(Aug 31, 2009) Indian pharmaceutical company Aurobindo Pharma has received the FDA's final approval for clindamycin hydrochloride capsules USP 150mg and 300mg. Clindamycin hydrochloride capsules USP 150mg and 300mg are generic equivalent to Cleocin Hydrochloride Capsules 150mg and 300mg of Pharmacia & Upjohn Company.
According to Aurobindo Pharma, clindamycin hydrochloride is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and falls under the anti-infective therapeutic segment. The product will be launched shortly.
Wednesday, September 2, 2009
Human trial of swine flu vaccine to begin in India
New Delhi: Search for a H1N1 Influenza A (swine flu) has intensified in India even as at least 100 people have already succumbed to the virus across the country.
With the death toll due to swine flu rising, the Health Ministry has decided to give a go ahead to clinical trials of influenza vaccine on humans
The vaccine being purchased by international pharma companies will be tried by Indian scientists to see its affect on Indians.
Centre has written to all the four international pharma giants - Glaxo Smithkline, Baxter, Novartis and Sanofi.
Glaxo is the first one to have come on board and has agreed to conduct clinical trials in the country after Central Government clears the number of units it needs.
But Health Ministry is of the view that trial should be conducted by Indian scientists to get an unbiased result.
"We want India to be a part of the global trial because the vaccine might react differently to Indians. In India the law is that even international companies have to conduct batch tests before they can be approved," says ICMR Director General Dr VM Katoch.
But before the clinical trials start the Health Ministry is debating on the sample size or minimum number of people on whom the vaccine needs to be tested before it can be cleared for use, and the number can go into thousands.
"In the past vaccines have had very unfortunate results. We have to gauge the expected and unexpected side effects before allowing them for common use," says Dr Katoch.
The clinical trials are likely to take about two months so the H1N1 vaccine will only be available around November.
The vaccines will be used for high risk groups including the medical fraternity and patients suffering from diabetes, chronic heart diseases and lung ailments. Also on the priority list are persons of the Armed Forces.
The four Indian companies who're also in the race to produce the vaccine indigenously are expected to be ready for clinical trials by November.
Sources in the Ministry say that till now Serum Institute is leading the vaccine race in the country. Once the Indian version of the vaccine is ready, it will be available to all.
With the death toll due to swine flu rising, the Health Ministry has decided to give a go ahead to clinical trials of influenza vaccine on humans
The vaccine being purchased by international pharma companies will be tried by Indian scientists to see its affect on Indians.
Centre has written to all the four international pharma giants - Glaxo Smithkline, Baxter, Novartis and Sanofi.
Glaxo is the first one to have come on board and has agreed to conduct clinical trials in the country after Central Government clears the number of units it needs.
But Health Ministry is of the view that trial should be conducted by Indian scientists to get an unbiased result.
"We want India to be a part of the global trial because the vaccine might react differently to Indians. In India the law is that even international companies have to conduct batch tests before they can be approved," says ICMR Director General Dr VM Katoch.
But before the clinical trials start the Health Ministry is debating on the sample size or minimum number of people on whom the vaccine needs to be tested before it can be cleared for use, and the number can go into thousands.
"In the past vaccines have had very unfortunate results. We have to gauge the expected and unexpected side effects before allowing them for common use," says Dr Katoch.
The clinical trials are likely to take about two months so the H1N1 vaccine will only be available around November.
The vaccines will be used for high risk groups including the medical fraternity and patients suffering from diabetes, chronic heart diseases and lung ailments. Also on the priority list are persons of the Armed Forces.
The four Indian companies who're also in the race to produce the vaccine indigenously are expected to be ready for clinical trials by November.
Sources in the Ministry say that till now Serum Institute is leading the vaccine race in the country. Once the Indian version of the vaccine is ready, it will be available to all.
Friday, August 7, 2009
Human trials of H1N1 vaccine by Dec: Serum
PUNE: The preventive vaccine against the H1N1 flu will be ready for clinical trials in humans by December, senior director of city-based Serum
Institute of India Limited (SIIL) Rajeev Dhere told on Thursday. "The development of the vaccine is in full swing. We obtained the H1N1 virus strain from UK-based National Institute for Biological Standards and Control (NIBSC) a month ago. If everything goes as per the scheduled plan and strategy, the vaccine will be out for human clinical trials in December," said Dhere. Elaborating on the scheduled plan of vaccine development, Dhere said, "First, a trial batch comprising a few thousand doses will be out and animal trials will be done by the third week of August to assess the immunogenicity of the vaccine," said Dhere. The company has zeroed in on two laboratories in India in Bangalore and Pune where animal trials will be carried out, Dhere added. "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted by the end of October to the Drugs Controller General of India (DCGI) for carrying out human clinical trials," said Dhere. "After obtaining the necessary permission from the DCGI, human clinical trials will begin in December," said Dhere. "The vaccine has to go through a regular testing process, but the DCGI had promised us they will do their best to fast-track the process following guidelines of the World Health Organisation (WHO) and European Medicines Agency," Dhere said. "If these human trials are successful, we have the technology to produce a vaccine which can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," he added. The SIIL was part of a teleconference spread over 30 countries with the director-general of the WHO, Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu hours after the disease was declared globally pandemic.
ANTI- H1N1 VACCINE DEVELOPMENT PLAN
1) SII obtains virus strain from UK-based NIBSC in July
2) Animal trials or pre-clinical trials will begin in August
3) A report of the toxicity and immunogenicity of the vaccine will be submitted to the DCGI in October
4) Safety trials in humans or clinical trials will begin by December
Institute of India Limited (SIIL) Rajeev Dhere told on Thursday. "The development of the vaccine is in full swing. We obtained the H1N1 virus strain from UK-based National Institute for Biological Standards and Control (NIBSC) a month ago. If everything goes as per the scheduled plan and strategy, the vaccine will be out for human clinical trials in December," said Dhere. Elaborating on the scheduled plan of vaccine development, Dhere said, "First, a trial batch comprising a few thousand doses will be out and animal trials will be done by the third week of August to assess the immunogenicity of the vaccine," said Dhere. The company has zeroed in on two laboratories in India in Bangalore and Pune where animal trials will be carried out, Dhere added. "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted by the end of October to the Drugs Controller General of India (DCGI) for carrying out human clinical trials," said Dhere. "After obtaining the necessary permission from the DCGI, human clinical trials will begin in December," said Dhere. "The vaccine has to go through a regular testing process, but the DCGI had promised us they will do their best to fast-track the process following guidelines of the World Health Organisation (WHO) and European Medicines Agency," Dhere said. "If these human trials are successful, we have the technology to produce a vaccine which can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," he added. The SIIL was part of a teleconference spread over 30 countries with the director-general of the WHO, Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu hours after the disease was declared globally pandemic.
ANTI- H1N1 VACCINE DEVELOPMENT PLAN
1) SII obtains virus strain from UK-based NIBSC in July
2) Animal trials or pre-clinical trials will begin in August
3) A report of the toxicity and immunogenicity of the vaccine will be submitted to the DCGI in October
4) Safety trials in humans or clinical trials will begin by December
Friday, July 31, 2009
Indian Pharma mkt valued at Rs 55,000 cr in FY09
The total size of Indian pharmaceutical industry, excluding exports and government purchases, stood at Rs 55,454 crore in the last fiscal, the Lok Sabha was informed today."As per the information available with the department through ORG-IMS, April (2009)MAT, value of Indian pharmaceutical market is Rs 55,454 crore," Minister of State for Chemical and Fertiliser Srikant Jena said while replying to a written query.The total value includes retail pharmaceutical market at Maximum Retail Price (MRP), generic and companies not tracked by ORG, hospitals and institutional sales excluding government procurement, direct doctor purchases, over the counter (OTC) products and diagnostics, Jena said."In addition to this, Indian pharma industry's export was worth Rs 38,433 crore in 2008-09," the minister added.The total size of the domestic industry in 2006-07 fiscal was at Rs 43,904 crore and in 2007-08 it was Rs 50,410 crore.
Wednesday, July 22, 2009
Healthcare industry to double in value by 2012: KPMG
Propelled by rising income levels as well as changing demographics and illness profiles, particularly with a shift from chronic to
lifestyle diseases, the Indian healthcare industry is estimated to double in value by 2012 at $14.2 billion and more than quadruple by 2017, says the latest Indian Healthcare edition of KPMG’s Global Infrastructure – Trend Monitor. According to the report, this is likely to result in considerable infrastructure challenges and opportunities. Of the 32 Indian states that the report considers, the six states of Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are estimated to represent approximately 50 per cent of the expenditure for the 2009-2013 period. Speaking on the release of this report, Pradip Kanakia, head of markets and healthcare services, KPMG, said, “While the Indian healthcare system has grown manifold over the past few years, it has yet not been able to keep pace with the rapid rise in the population. One example of that is the availability of hospital beds in our country – against a world average of 4 beds per 1000 population, India lags behind at just over 0.7 presently.” Thus, there is a dire need to introduce some radical reforms in the healthcare infrastructure development process. For instance, use of PPP models on a larger scale and foreign investments are some which could be considered. The report suggests that there is a growing need to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased the demand for these services. The report also looks into the fact that the Indian healthcare system is controlled by respective state authorities, presenting an opportunity to improve responsiveness to healthcare needs at a more local level. Ameeta Chatterjee, director - corporate finance, KPMG, said, “There has been an increasing awareness of private sector involvement in meeting the requirement of the country’s health services requirement. The Indian solutions that will evolve need to be focused on developing affordable, low cost basic healthcare services with scalability and sustainability as key drivers.” The report suggests that there is opportunity to improve responsiveness to the country’s healthcare needs at a more local level due to uneven focus on healthcare infrastructure in India This can be attributed to the healthcare system in the country which is controlled by respective state authorities. The variety of organizational structures and processes in healthcare delivery may result in greater inequalities between geographical areas. There is a growing agenda to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased demand for these services.
lifestyle diseases, the Indian healthcare industry is estimated to double in value by 2012 at $14.2 billion and more than quadruple by 2017, says the latest Indian Healthcare edition of KPMG’s Global Infrastructure – Trend Monitor. According to the report, this is likely to result in considerable infrastructure challenges and opportunities. Of the 32 Indian states that the report considers, the six states of Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are estimated to represent approximately 50 per cent of the expenditure for the 2009-2013 period. Speaking on the release of this report, Pradip Kanakia, head of markets and healthcare services, KPMG, said, “While the Indian healthcare system has grown manifold over the past few years, it has yet not been able to keep pace with the rapid rise in the population. One example of that is the availability of hospital beds in our country – against a world average of 4 beds per 1000 population, India lags behind at just over 0.7 presently.” Thus, there is a dire need to introduce some radical reforms in the healthcare infrastructure development process. For instance, use of PPP models on a larger scale and foreign investments are some which could be considered. The report suggests that there is a growing need to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased the demand for these services. The report also looks into the fact that the Indian healthcare system is controlled by respective state authorities, presenting an opportunity to improve responsiveness to healthcare needs at a more local level. Ameeta Chatterjee, director - corporate finance, KPMG, said, “There has been an increasing awareness of private sector involvement in meeting the requirement of the country’s health services requirement. The Indian solutions that will evolve need to be focused on developing affordable, low cost basic healthcare services with scalability and sustainability as key drivers.” The report suggests that there is opportunity to improve responsiveness to the country’s healthcare needs at a more local level due to uneven focus on healthcare infrastructure in India This can be attributed to the healthcare system in the country which is controlled by respective state authorities. The variety of organizational structures and processes in healthcare delivery may result in greater inequalities between geographical areas. There is a growing agenda to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased demand for these services.
Three Indian biotech cos get nod to develop swine flu vaccine
NEW DELHI: India’s drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu,
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.
DCGI, India to set up own labs to test new drugs
NEW DELHI: India’s top drug regulator Drug Controller General of India (DCGI) has identified six labs to test new drugs before launching them in the
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.
Saturday, June 27, 2009
Sandoz receives approval for Japanese biosimilar
Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.Sandoz CEO Jeff George said, "We are pleased that Sandoz, the pioneer in biosimilars and a company with a global reputation for offering high quality medicines at affordable prices, is paving the way in Japan as well. Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over the years and decades to come, both in Japan and worldwide."The Ministry of Health, Labour and Wealth (MHLW) announced the approval on June 22, barely three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles to the approval pathway already in place in the European Union.The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg / 10mg [Sandoz]. It is approved for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. This is the same range of indications covered by the reference product, Genotropin, as approved in Japan. It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product.Sandoz pioneered the field of biosimilars / follow-on biologics with the approval and subsequent launch of Omnitrope in the US and Europe. Omnitrope was the first such product to be made available to patients in both regions and the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products. Sandoz is the only company with three biosimilar medicines marketed in Europe.Biosimilars are an integral part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits. Due to the rising costs of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring and broadening global access to medicines. Sandoz is building a strong global biosimilar pipeline, with numerous projects at all stages of development.
St hammers Sun Pharma as USFDA seizes 33 drugs of arm
MUMBAI: US authorities seized drugs made by Sun Pharmaceuticals’ US subsidiary for violation of manufacturing standards, pushing down share prices
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
US drug officals raid Sun Pharma subsidiary in Michigan
MUMBAI: The US Food and Drug Administration (FDA) on Thursday seized 33 drugs manufactured by a subsidiary of Indian pharma major Sun
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Tuesday, June 23, 2009
Dr Reddy's launches Bispec in India
Dr Reddy's Laboratories, the second largest Indian pharma giant, has commenced marketing of Bispec (Solifencin succinate) in India for the treatment of over active bladder (OAB). Bispec is the best-in-class for OAB and has lesser incidence of dry mount and constipation. The product is available in tablet form and in dosages of 5 mg and 10 mg.People suffering from OAB have a warning time of about 12 seconds. Solifencin succinate helps to increase the warning time to about 32 seconds. The market size for product used in the treatment of OAB is about Rs 19.4 crore and it growing at a rate of 7 per cent per annum. Solifencin acts by competitively inhibiting Acetyl choline from binding to cholinergic receptors present in bladder. This reduces bladder contractions and improves warning time in over active bladder patients. DRL has other leading brand TORQ in this segment.
Aurobindo gets nod for 5 new registrations from MCC - South Africa
Aurobindo Pharma Ltd, Hyderabad based generic pharmaceutical and API company, has received Medicines Control Council (MCC) South Africa's approval to manufacture and market five products in South Africa.According to a company press release, the MCC has approved two ARV category drugs of Auro-Abacavir 300mg tablets (Abacavir), Auro-Abacavir 20mg/ml (Abacavir) oral solution and three anti-infective category drugs of Auroprozil 250mg & 500mg (Cefprozil) tablets, Auro-Cefotaxime 250mg, 500mg, 1000mg & 2000mg (Cefotaxime) injection and Auro-Cefalexin 250mg & 750mg (Cefalexin) tablets. Aurobindo now has a total of 36 registrations approved by the MCC, the release said.
German, UK-based biotech cos eye India for outsourcing
BANGALORE: As part of the cost-cutting measures to combat global recession, German and UK-based biotech companies plan to outsource more work,
transfer technology and tap India’s burgeoning biotechnology market.
“We will see more collaborations in industrial enzyme technology, bio-food technology, renewable energies and regenerative medicine. Several companies plan to bring in over $100 million investments to India this year and set up production facilities here,” said Martin Pohle, consultant Bio Mitteldeutschland Gmbh, which works towards strengthening the BT industry in Anhalt, Central Germany. The Indian bio-tech industry is poised to grow by 18% in FY09 to Rs 12,137 crore from Rs 10,274 crore in FY08, said CMD of Biocon Kiran Mazumdar Shaw. This year, more partnerships are likely to be struck between Western and Indian companies, she said. Germany’s Biobase Gmbh, which provides biological databanks, will be bringing more work to India and expand its infrastructure. “We have more than 50% cost advantage in India, and now only 10-15% of our work is done in Germany, 85% of the work is done in India,” said Biobase CEO, Michael Tysiak. Companies like UK-based Oxygen Healthcare (O2H) are setting up new labs in Ahmedabad SEZ. It will source molecules from India because of the cost advantage here and market them in Japan, US and Europe. These molecules will be used for drug discovery procedures for diseases such as cancer. “The Indian base makes us competitive. We are able to deliver the same kind of quality as in the UK and US, where you pay three times more compared to India,” said Ekta Ahuja, manager business development, O2H. Britian’s Institute of Pharmaceutical Innovations (IPI) is looking at a JV with Indian companies and will transfer technology through its two spin-outs — Crystec Pharma and Lena Naoceutics. “With Crystec, we have a plant in China and now we want to set up a plant in India. We will collaborate with Indian partners through Lenananoceutics. A total investment of £20 million is required for these ventures,” said Anant Paradkar, professor at IPI.
transfer technology and tap India’s burgeoning biotechnology market.
“We will see more collaborations in industrial enzyme technology, bio-food technology, renewable energies and regenerative medicine. Several companies plan to bring in over $100 million investments to India this year and set up production facilities here,” said Martin Pohle, consultant Bio Mitteldeutschland Gmbh, which works towards strengthening the BT industry in Anhalt, Central Germany. The Indian bio-tech industry is poised to grow by 18% in FY09 to Rs 12,137 crore from Rs 10,274 crore in FY08, said CMD of Biocon Kiran Mazumdar Shaw. This year, more partnerships are likely to be struck between Western and Indian companies, she said. Germany’s Biobase Gmbh, which provides biological databanks, will be bringing more work to India and expand its infrastructure. “We have more than 50% cost advantage in India, and now only 10-15% of our work is done in Germany, 85% of the work is done in India,” said Biobase CEO, Michael Tysiak. Companies like UK-based Oxygen Healthcare (O2H) are setting up new labs in Ahmedabad SEZ. It will source molecules from India because of the cost advantage here and market them in Japan, US and Europe. These molecules will be used for drug discovery procedures for diseases such as cancer. “The Indian base makes us competitive. We are able to deliver the same kind of quality as in the UK and US, where you pay three times more compared to India,” said Ekta Ahuja, manager business development, O2H. Britian’s Institute of Pharmaceutical Innovations (IPI) is looking at a JV with Indian companies and will transfer technology through its two spin-outs — Crystec Pharma and Lena Naoceutics. “With Crystec, we have a plant in China and now we want to set up a plant in India. We will collaborate with Indian partners through Lenananoceutics. A total investment of £20 million is required for these ventures,” said Anant Paradkar, professor at IPI.
Pfizer charges Sun with another patent violation
MUMBAI: A legal battle between US pharma giant Pfizer and Indian company Sun Pharmaceutical has escalated, with the world’s largest maker of
medicines alleging in court filings that in addition to the original patent that it claims Sun violated, it infringed another patent when it sought approval for its generic version of Lyrica, a blockbuster drug used to treat seizures. In a case filed in the US District Court for the District of Delaware on May 3, 2009, Pfizer had alleged that Sun infringed on a patent that Pfizer and Northwestern University held. Last week, the company charged Sun with violating another patent for Lyrica. Incidentally, Pfizer will lose patent protection for this drug only in 2018. Lyrica (pregabalin) is used for treating pain caused by neurological diseases such as postherpetic neuralgia as well as seizures. Lyrica currently ranks third in the anti-seizure market, and is estimated to have global sales of approximately $1.2 billion. The drug’s sales jumped 45% in 2008 to $675 million, offsetting Pfizer’s losses from its blockbuster drug Lipitor. Lyrica may become Pfizer’s leading product by 2012. The pharma giant, in its filing, said it had received a letter from Sun Pharma informing that Sun’s abbreviated new drug application (ANDA) contained a claim that the “175 patent was invalid, unenforceable, and not infringed by Sun’s proposed product”. Pfizer is seeking an injunction that would bar Sun from marketing and manufacturing generic versions of Lyrica (pregabalin) prior to patent expiration as well as monetary relief, if Sun were to sell its generic product, and fees and costs.” When contacted, a Sun Pharma spokesperson said: “We don’t comment on our product pipeline or the associated litigation.” Indian pharma majors Lupin and Wockhardt have also been taken to court by Pfizer for infringement of other patents related to the same drug. Teva, Sandoz, Actavis, Cobalt Laboratories, Alphapharm are some of the other generic companies that Pfizer is in litigation with over Lyrica.
medicines alleging in court filings that in addition to the original patent that it claims Sun violated, it infringed another patent when it sought approval for its generic version of Lyrica, a blockbuster drug used to treat seizures. In a case filed in the US District Court for the District of Delaware on May 3, 2009, Pfizer had alleged that Sun infringed on a patent that Pfizer and Northwestern University held. Last week, the company charged Sun with violating another patent for Lyrica. Incidentally, Pfizer will lose patent protection for this drug only in 2018. Lyrica (pregabalin) is used for treating pain caused by neurological diseases such as postherpetic neuralgia as well as seizures. Lyrica currently ranks third in the anti-seizure market, and is estimated to have global sales of approximately $1.2 billion. The drug’s sales jumped 45% in 2008 to $675 million, offsetting Pfizer’s losses from its blockbuster drug Lipitor. Lyrica may become Pfizer’s leading product by 2012. The pharma giant, in its filing, said it had received a letter from Sun Pharma informing that Sun’s abbreviated new drug application (ANDA) contained a claim that the “175 patent was invalid, unenforceable, and not infringed by Sun’s proposed product”. Pfizer is seeking an injunction that would bar Sun from marketing and manufacturing generic versions of Lyrica (pregabalin) prior to patent expiration as well as monetary relief, if Sun were to sell its generic product, and fees and costs.” When contacted, a Sun Pharma spokesperson said: “We don’t comment on our product pipeline or the associated litigation.” Indian pharma majors Lupin and Wockhardt have also been taken to court by Pfizer for infringement of other patents related to the same drug. Teva, Sandoz, Actavis, Cobalt Laboratories, Alphapharm are some of the other generic companies that Pfizer is in litigation with over Lyrica.
Retail sale of swine flu drug under lens
NEW DELHI: The Drug Controller General of India (DCGI) may soon crack the whip on those selling oseltamivir, the medicine to treat swine flu, in
retail stores. In a move to step up vigil on the retail sale of the drug at high prices, the DCGI has asked all state drug inspectors to keep a check on the movement, manufacture and sale of the medicine in their jurisdictions, a health ministry official, who asked not to be named, said. The present warning from the health ministry reiterating that the drug should not be sold in the open market and in private hospitals by pharmacies comes at a time when companies are urging the government to allow retail sale of the drug.Drug makers manufacturing or importing oseltamivir are allowed to either sell it to government hospitals or directly to the government through a tender. The government is worried about a possible illegal stocking of the drug and panic consumption that could result in the virus developing a resistance to the medicine. “There may be people willing to take advantage of swine flu and make money out of it. This product is meant for government supply only and it is not permitted to be sold through retail chemists and druggists in India. Indiscriminate use of this drug by the public could result in the virus developing resistance to this,” the official said. Companies, such as Cipla, Ranbaxy and Hetero, have developed generic version of the drug. The DCGI’s move was prompted by reports that the only drug, oseltamivir, to treat swine flu is available at various pharmaceutical retail outlet at a very high price. The World Health Organisation (WHO) has reported 35,928 laboratory confirmed cases of H1N1 influenza, from 76 countries till Monday. According to the health ministry, so far samples of 329 persons have been tested in India, of which 35 have been tested positive for novel influenza A H1N1.
retail stores. In a move to step up vigil on the retail sale of the drug at high prices, the DCGI has asked all state drug inspectors to keep a check on the movement, manufacture and sale of the medicine in their jurisdictions, a health ministry official, who asked not to be named, said. The present warning from the health ministry reiterating that the drug should not be sold in the open market and in private hospitals by pharmacies comes at a time when companies are urging the government to allow retail sale of the drug.Drug makers manufacturing or importing oseltamivir are allowed to either sell it to government hospitals or directly to the government through a tender. The government is worried about a possible illegal stocking of the drug and panic consumption that could result in the virus developing a resistance to the medicine. “There may be people willing to take advantage of swine flu and make money out of it. This product is meant for government supply only and it is not permitted to be sold through retail chemists and druggists in India. Indiscriminate use of this drug by the public could result in the virus developing resistance to this,” the official said. Companies, such as Cipla, Ranbaxy and Hetero, have developed generic version of the drug. The DCGI’s move was prompted by reports that the only drug, oseltamivir, to treat swine flu is available at various pharmaceutical retail outlet at a very high price. The World Health Organisation (WHO) has reported 35,928 laboratory confirmed cases of H1N1 influenza, from 76 countries till Monday. According to the health ministry, so far samples of 329 persons have been tested in India, of which 35 have been tested positive for novel influenza A H1N1.
Sun Pharma USFDA nod for anti hypertensive drug
MUMBAI: Sun Pharmaceutical Industries on Friday said it has got the approval for its Abbreviated New Drug Application (ANDA) for the generic version
of Quinapril Hydrochloride tablets used in the treatment of hypertension and congested heart failure. The Quinapril Hydrochloride Tablets are generic version of 'Accupril' tablets from Pfizer's portfolio and are available in four strengths, the company said in a filing to Bombay Stock Exchange. The drug have annual sales of approximately $ 45 million in US, it added.
of Quinapril Hydrochloride tablets used in the treatment of hypertension and congested heart failure. The Quinapril Hydrochloride Tablets are generic version of 'Accupril' tablets from Pfizer's portfolio and are available in four strengths, the company said in a filing to Bombay Stock Exchange. The drug have annual sales of approximately $ 45 million in US, it added.
NEW DELHI: Elder Pharmaceuticals has signed an agreement with US-based MD Anderson Cancer Center to conduct human experiments for its
NEW DELHI: The domestic pharmaceutical industry has demanded exemption in income-tax and fiscal incentives in the forthcoming Budget for promoting
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
Elder signs deal with US co for human trials of anti-cancer drug
NEW DELHI: Elder Pharmaceuticals has signed an agreement with US-based MD Anderson Cancer Center to conduct human experiments for its
newly-discovered anti-cancer drug. As per the agreement, the cancer centre will invest into human trials in the US, while Elder Pharmaceuticals would retain exclusive manufacturing rights for the drug. “The deal is unique, as the ownership rights of the drug will lie with MD Anderson and the manufacturing rights will be with Elder. MD Anderson has the option of selling the rights to any major pharma company in the world, but that company will have to manufacture the same only through Elder,” said Elder Pharmaceuticals director (international) Alok Saxena. The anti-cancer drug, developed by Elder Pharmaceuticals, is an alternative to chemotherapy, and hence, has no known major side-effects, said a company official. The drug can be delivered both through intravenous as well as oral methods. The company expects the commercial launch of the drug by 2012. The market size for such cancer therapies is estimated to be at around $3 billion across the globe. The US, Europe and Japan together contribute 78% to this market. Elder estimates this drug to have a potential to capture a global market share of 3-4%. According to a company official, the cancer centre is likely to invest around $200 million on human trials. Elder Pharmaceuticals has a presence in niche therapeutic segments, such as female healthcare, osteoporosis, dermatology, pain management, cardiology, diabetology, nutraceuticals and vitamin supplements. The company also have a major presence in calcium supplements, wound healing and injectable B12 vitamin. The company shares dipped 3.83% to Rs 27.60 at the Bombay Stock Exchange on Thursday. The company follows the non-infringing business model of either in-licensing products of innovator companies or manufacturing off-patented drugs. It has entered into marketing and manufacturing alliances with 30 international companies to launch their research-based products in India, said the official.
newly-discovered anti-cancer drug. As per the agreement, the cancer centre will invest into human trials in the US, while Elder Pharmaceuticals would retain exclusive manufacturing rights for the drug. “The deal is unique, as the ownership rights of the drug will lie with MD Anderson and the manufacturing rights will be with Elder. MD Anderson has the option of selling the rights to any major pharma company in the world, but that company will have to manufacture the same only through Elder,” said Elder Pharmaceuticals director (international) Alok Saxena. The anti-cancer drug, developed by Elder Pharmaceuticals, is an alternative to chemotherapy, and hence, has no known major side-effects, said a company official. The drug can be delivered both through intravenous as well as oral methods. The company expects the commercial launch of the drug by 2012. The market size for such cancer therapies is estimated to be at around $3 billion across the globe. The US, Europe and Japan together contribute 78% to this market. Elder estimates this drug to have a potential to capture a global market share of 3-4%. According to a company official, the cancer centre is likely to invest around $200 million on human trials. Elder Pharmaceuticals has a presence in niche therapeutic segments, such as female healthcare, osteoporosis, dermatology, pain management, cardiology, diabetology, nutraceuticals and vitamin supplements. The company also have a major presence in calcium supplements, wound healing and injectable B12 vitamin. The company shares dipped 3.83% to Rs 27.60 at the Bombay Stock Exchange on Thursday. The company follows the non-infringing business model of either in-licensing products of innovator companies or manufacturing off-patented drugs. It has entered into marketing and manufacturing alliances with 30 international companies to launch their research-based products in India, said the official.
Wednesday, June 17, 2009
Pharma Dept sets up task force to implement industry recommendations on R&D
New Delhi:- The Department of Pharmaceuticals has set up a task force to implement a number of proposals including special support on the small and medium sector for taking up research and development activities and project funding through special purpose vehicle, as part of the target to make India a hub for R&D in pharma.
The department recently held a brainstorming session on the topic with the industry representatives to elicit their views and chalked out a set of recommendations which will be implemented under the guidance of the task force. Industry will interact with university system to make use of the available expertise and facilities, inventory of expertise and technology with universities will be compiled, and project funding would be implemented, according to the set of recommendations made by the meeting.
Technology forecasting for neglected diseases, identification of institutions abroad for training and exchange programmes, and support to SMEs were among the other recommendations. The task force will have representatives of Torrent, Sam Pharma, Piramal Healthcare, Alkem, FICCI representative and Lalit Kumar Jain of SPIC as members. The participants at the meeting also have been asked to send their suggestions and take up the prevailing statutory barriers with the department.
Pharma secretary Ashok Kumar, while urging the industry to focuses on R&D, asked the industry to forward suggestions as to what the department could do to facilitate research. The perception of the industry was solicited to consolidate efforts towards process development for generics and enlarge geographical boundaries. The brainstorming session covered areas like structural issues, activities on new chemical entities, human resources development, honouring scientists, infrastructure, project funding, and fiscal incentives.
The Department also sought the opinion of the industry on setting up a special purpose vehicle for project funding and reduce the risk in R&D investment through an insurance coverage. The industry, on its part, said it could shoulder 50 per cent of R&D expenses while the rest should be found from other sources. The department said the government may not be in a position to extend financial assistance.
The department recently held a brainstorming session on the topic with the industry representatives to elicit their views and chalked out a set of recommendations which will be implemented under the guidance of the task force. Industry will interact with university system to make use of the available expertise and facilities, inventory of expertise and technology with universities will be compiled, and project funding would be implemented, according to the set of recommendations made by the meeting.
Technology forecasting for neglected diseases, identification of institutions abroad for training and exchange programmes, and support to SMEs were among the other recommendations. The task force will have representatives of Torrent, Sam Pharma, Piramal Healthcare, Alkem, FICCI representative and Lalit Kumar Jain of SPIC as members. The participants at the meeting also have been asked to send their suggestions and take up the prevailing statutory barriers with the department.
Pharma secretary Ashok Kumar, while urging the industry to focuses on R&D, asked the industry to forward suggestions as to what the department could do to facilitate research. The perception of the industry was solicited to consolidate efforts towards process development for generics and enlarge geographical boundaries. The brainstorming session covered areas like structural issues, activities on new chemical entities, human resources development, honouring scientists, infrastructure, project funding, and fiscal incentives.
The Department also sought the opinion of the industry on setting up a special purpose vehicle for project funding and reduce the risk in R&D investment through an insurance coverage. The industry, on its part, said it could shoulder 50 per cent of R&D expenses while the rest should be found from other sources. The department said the government may not be in a position to extend financial assistance.
GSK ties up with Dr Reddy's Labs to develop & market selected products in emerging markets
Mumbai-GlaxoSmithKline plc (GSK) announced an agreement with Dr Reddy's Laboratories Ltd (Dr Reddy's) to develop and market selected products across an extensive number of emerging markets, excluding India.Abbas Hussain, president emerging markets, GlaxoSmithKline said, "This is another significant step forward in our strategy to grow and diversify GSK's business in emerging markets. Growth in both population and economic prosperity is leading to increased demand for branded pharmaceuticals. This new alliance will combine Dr Reddy's portfolio of quality branded pharmaceuticals together with GSK's extensive sales and marketing capabilities. Together we will be able to deliver more medicines of value to more patients in these countries."GV Prasad, vice chairman & CEO, Dr Reddy's said, "We are extremely pleased to combine forces with GSK, a global leader, to fully realise the potential of our strengths in technology, product development and manufacturing across a range of high growth emerging markets. We hope to take our purpose of providing affordable and innovative medicines to a much wider population through this partnership."Under the terms of the agreement, which is already effective, GSK will gain exclusive access to Dr Reddy's rich and diverse portfolio and future pipeline of more than 100 branded pharmaceuticals in fast growing therapeutic segments such as cardiovascular, diabetes, oncology, gastroenterology and pain management.The products will be manufactured by Dr Reddy's, and licensed and supplied by GSK in various countries in Africa, the Middle East, Asia Pacific and Latin America. In certain markets, products will be co-marketed by the GSK and Dr Reddy's. Under the terms of the agreement, revenues will be reported by GSK and shared with Dr Reddy's as per the agreed terms.
Advinus Therapeutics' new drug discovery facility in Pune commissioned
Mumbai-Advinus Therapeutics, a TATA enterprise, announced that it has commissioned a new state-of-the-art drug discovery facility in Pune. In the first phase, the company has commissioned about 70,000 sq ft of lab and office space and has another 40,000 sq ft of expansion space. The new facilities have been meticulously designed keeping in mind the collaborative nature of pharmaceutical innovation and need for exchange of ideas between scientists. In another key development, the company also announced that it has filed its first IND with the DCGI last week for a type-2 diabetes molecule and expects to commence phase-1 clinical trials shortly after approval. Speaking on the occasion, Dr Rashmi Barbhaiya, the CEO and managing director of the company stated, "Our drug discovery operations have now been expanded to almost three folds of what they were. The new facility will give us a lot of room for growth of internal programmes and innovative models for future partnerships. I am very proud that in less than three years we have been able to file our first IND for approval of clinical trials which is a combined effort of both our Pune and Bangalore operations."Dr Kasim Mookhtiar, chief scientific officer of the company said, "The filing of Advinus' first IND marks the beginning of the company's delivery of a pipeline of innovative products that addresses large unmet medical needs."
Baxter expects to deliver A/H1N1 vaccine to WHO by July
Baxter International Inc. has completed testing and evaluation of the A/H1N1 influenza virus and is now in full-scale production of a commercial A/H1N1 vaccine using its Vero cell culture technology. Baxter received an A/H1N1 strain from the US Centers for Disease Control and Prevention [a World Health Organization (WHO) Collaborating Center] in early May and is diligently working to deliver a pandemic vaccine for use as early as July.WHO raised the pandemic alert level to phase-6, indicating a global influenza pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and other global public health authorities regarding the pandemic. A number of national public health authorities have existing pandemic agreements with Baxter that allow them to place orders for a vaccine now that a pandemic has been declared by WHO. These public health authorities will be evaluating their needs to determine their orders for vaccine supply. Despite the company's existing obligations to supply vaccine under a pandemic phase-6 alert, Baxter is also committed to working with WHO to allocate a portion of the company's commercial production to address global public health issues deemed most urgent.Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) approval for a mock-up pandemic vaccine called Celvapan, the brand name for the company's pandemic vaccine. The qualification, development and manufacturing processes used in gaining mock-up licensure for Celvapan apply as the company uses this new influenza A/H1N1 virus strain to produce a pandemic vaccine. The Celvapan EMEA licensure supports fast track approval of a pandemic vaccine containing the A/H1N1 virus strain. Baxter will submit the A/H1N1 vaccine for approval upon completion of initial manufacturing runs.Baxter's research and development, manufacturing capabilities and pandemic planning expertise allow the company to efficiently develop candidate vaccines against potentially emerging influenza viruses. Baxter believes that its Vero cell technology can be used to safely and reliably produce a vaccine in response to this global public health issue. It is possible that Baxter's Vero cell technology may offer advantages, in that it may allow more rapid production and delivery of pandemic vaccines.Baxter International through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.
New price formula for 184 drugs; 77 to get cheaper
NEW DELHI: The country’s top drug price regulator has reworked the prices of 184 bulk drugs, thus making 77 medicines more affordable, and brought
in another 71 under its purview. The National Pharmaceutical Pricing Authority (NPPA), which fixes the prices of bulk drugs that go into the making of essential medicines to ensure that they stay within the reach of the common man, also hiked the prices of 36 medicines. “While some of the prices are reduced suo moto based on the reduction in their bulk drug prices, prices of some were revised based on the applications received from drug companies asking for a price revision,” an NPPA official said. Among the medicines that have become cheaper include those used in the treatment of arthritis, eye ailments, diabetes and infections, and some antibiotics, primarily marketed by companies such as Pfizer and Novartis. The price reduction is in the range of 0.41-34.38%. For instance, the price of a 2-ml vial of Pfizer’s Medrol 80-mg, a steroid used for treatment of arthritis, will now cost Rs 75.76 instead of Rs 88. 79. A 30-ml bottle of Novartis’ Vitalux TR tablets will now cost Rs 262.53 instead of Rs 304.76. Vitalux TR is a specially tailored combination of vitamins and minerals to maintain healthy eyes. NPPA fixes the prices of 74 bulk drugs, used to manufacture essential medicines, and revise their prices periodically based on a cost study. Prices of all medicines containing one or more of these bulk drugs are also directly controlled by the pricing authority. However, companies manufacturing any other medicines can increase the price of their drug by 10% annually. The latest price revision by NPPA also includes medicines that were being sold in the market without a price approval, the official said. The regulator has caught such price violations, calculated their cost of production and fixed the prices at which they should be sold henceforth. After this, selling these 71 medicines above the government fixed price would make the producers liable for punishment.
in another 71 under its purview. The National Pharmaceutical Pricing Authority (NPPA), which fixes the prices of bulk drugs that go into the making of essential medicines to ensure that they stay within the reach of the common man, also hiked the prices of 36 medicines. “While some of the prices are reduced suo moto based on the reduction in their bulk drug prices, prices of some were revised based on the applications received from drug companies asking for a price revision,” an NPPA official said. Among the medicines that have become cheaper include those used in the treatment of arthritis, eye ailments, diabetes and infections, and some antibiotics, primarily marketed by companies such as Pfizer and Novartis. The price reduction is in the range of 0.41-34.38%. For instance, the price of a 2-ml vial of Pfizer’s Medrol 80-mg, a steroid used for treatment of arthritis, will now cost Rs 75.76 instead of Rs 88. 79. A 30-ml bottle of Novartis’ Vitalux TR tablets will now cost Rs 262.53 instead of Rs 304.76. Vitalux TR is a specially tailored combination of vitamins and minerals to maintain healthy eyes. NPPA fixes the prices of 74 bulk drugs, used to manufacture essential medicines, and revise their prices periodically based on a cost study. Prices of all medicines containing one or more of these bulk drugs are also directly controlled by the pricing authority. However, companies manufacturing any other medicines can increase the price of their drug by 10% annually. The latest price revision by NPPA also includes medicines that were being sold in the market without a price approval, the official said. The regulator has caught such price violations, calculated their cost of production and fixed the prices at which they should be sold henceforth. After this, selling these 71 medicines above the government fixed price would make the producers liable for punishment.
Monday, June 15, 2009
SPV with cover for drug R&D soon
NEW DELHI: In a bid to promote new drug research in the country, the government is mulling creating special purpose vehicles (SPV) with insurance
cover which will be used to fund new drug research. The department of pharma is also toying with the idea of creating drug research facilities and centres that can be used by private companies for such research work on a pay-and-use basis. The suggestions are part of the initiatives proposed by pharma secretary Ashok Kumar in a recent meeting with the industry. The meeting was held in view of the government’s plan to make the country a hub for drug research and development (R&D). While a successful drug development project will provide lucrative returns, it is a risky investment and chances of failure are very high. “One possibility could be operate through a SPV route and the risk be covered through the insurance plan,” Mr Kumar said. But as the government has other priorities that are of social importance, financial help may not be viable. However, the department has sought the industry’s view to explore the proposal. Presently, the government provides 150% tax exemptions for investment made by drug companies in drug R&D.Globally, it takes up to a $1 billion to successfully develop a drug and funding is largely done by the companies themselves. In India, it is much lower. Indian companies have mastered the art of reverse engineering or developing low-cost version of off-patented drugs. But the industry is at a nascent stage in terms of developing new original drugs. Many big home grown companies are now making attempts to move to the second stage of drug research. Companies such as Ranbaxy, Glenmark, Dr Reddy’s, Sun Pharma, Biocon and Piramal Life Sciences have several new drugs in their pipeline but most don’t have the financial muscle to entirely fund the investment. Some of these drugs target diseases like Malaria which are widely prevalent in India and Africa, that have been neglected by global MNCs as the market for such is not lucrative enough. But as per SME Pharma Industries Confederation (SPIC) senior vice chairman Lalit Kumar Jain Indian companies should continue to focus on developing generic drugs as medicines made from 350 APIs (active pharmaceutical ingredients) can treat of more than 90% of the diseases in India. Unlike in western countries, there are thousands of small and medium drug makers in India and the government should also support research in small companies which focus on generic drugs.
cover which will be used to fund new drug research. The department of pharma is also toying with the idea of creating drug research facilities and centres that can be used by private companies for such research work on a pay-and-use basis. The suggestions are part of the initiatives proposed by pharma secretary Ashok Kumar in a recent meeting with the industry. The meeting was held in view of the government’s plan to make the country a hub for drug research and development (R&D). While a successful drug development project will provide lucrative returns, it is a risky investment and chances of failure are very high. “One possibility could be operate through a SPV route and the risk be covered through the insurance plan,” Mr Kumar said. But as the government has other priorities that are of social importance, financial help may not be viable. However, the department has sought the industry’s view to explore the proposal. Presently, the government provides 150% tax exemptions for investment made by drug companies in drug R&D.Globally, it takes up to a $1 billion to successfully develop a drug and funding is largely done by the companies themselves. In India, it is much lower. Indian companies have mastered the art of reverse engineering or developing low-cost version of off-patented drugs. But the industry is at a nascent stage in terms of developing new original drugs. Many big home grown companies are now making attempts to move to the second stage of drug research. Companies such as Ranbaxy, Glenmark, Dr Reddy’s, Sun Pharma, Biocon and Piramal Life Sciences have several new drugs in their pipeline but most don’t have the financial muscle to entirely fund the investment. Some of these drugs target diseases like Malaria which are widely prevalent in India and Africa, that have been neglected by global MNCs as the market for such is not lucrative enough. But as per SME Pharma Industries Confederation (SPIC) senior vice chairman Lalit Kumar Jain Indian companies should continue to focus on developing generic drugs as medicines made from 350 APIs (active pharmaceutical ingredients) can treat of more than 90% of the diseases in India. Unlike in western countries, there are thousands of small and medium drug makers in India and the government should also support research in small companies which focus on generic drugs.
Consolidation helps foreign pharma majors lead the India rank list
NEW DELHI: Merger and acquisitions (M&As) in the domestic and international pharma industry are gradually changing the Indian pharma landscape
in favour of foreign players. After acquiring Ranbaxy Laboratories, Japan’s Daiichi Sankyo has jumped to the second position in the domestic pharma market, behind market leader Cipla. Ranbaxy is India’s largest pharma company by sales, but is ranked second in the Rs 35,000-crore domestic market. Similarly, the world’s largest drugmaker Pfizer will be among the top eight firms in the domestic market once its integration with Wyeth’s India arm gets over. Pfizer agreed to buy Wyeth for $68 billion in January this year. Currently, the American firm is ranked 12th in the domestic market. Last week, Pfizer announced the acquisition of ICICI Venture-owned RFCL’s Rs 100-120 crore animal healthcare business. Besides, it’s in talks with Indian pharma companies for a strategic acquisition that could further strengthen the American giant’s hold in the domestic market. Another US major MSD will be catapulted to the top 35 in India, after it completes its acquisition of rival Schering Plough. Similarly, French major Sanofi Aventis, which is looking for acquisitions in India, could see a successful bid putting it back to the top 10 from its current position of 16. Before the recent round of M&As, India’s pharma market had only one foreign player — the UK-based GlaxoSmithKline (GSK) — among the top 10. Multinational companies, such as Pfizer, GSK and Novartis, played a dominant role in the domestic market till as recent as early-2007, but lost out to homegrown generics majors, such as Cipla, Ranbaxy and Zydus Cadilla. HDFC Securities institutional research VP Ranjit Kapadia said: “Till mid-90’s, foreign pharma firms dominated the Indian pharma industry. The introduction of the drug price control order in 1995 brought many of their drugs under price control, thus restricting their growth. At the same time, Indian pharma companies launched a slew of generic drugs outside price control, which boosted their growth.” Besides consolidation, a new patent regime will also drive the growth of foreign companies in India. Launched in 2005, the new patent laws provide patent holders exclusive marketing rights in India for 20 years. This will protect foreign pharma firms that hold patents from losing out to Indian companies that make low-cost copies of off-patent drugs.
in favour of foreign players. After acquiring Ranbaxy Laboratories, Japan’s Daiichi Sankyo has jumped to the second position in the domestic pharma market, behind market leader Cipla. Ranbaxy is India’s largest pharma company by sales, but is ranked second in the Rs 35,000-crore domestic market. Similarly, the world’s largest drugmaker Pfizer will be among the top eight firms in the domestic market once its integration with Wyeth’s India arm gets over. Pfizer agreed to buy Wyeth for $68 billion in January this year. Currently, the American firm is ranked 12th in the domestic market. Last week, Pfizer announced the acquisition of ICICI Venture-owned RFCL’s Rs 100-120 crore animal healthcare business. Besides, it’s in talks with Indian pharma companies for a strategic acquisition that could further strengthen the American giant’s hold in the domestic market. Another US major MSD will be catapulted to the top 35 in India, after it completes its acquisition of rival Schering Plough. Similarly, French major Sanofi Aventis, which is looking for acquisitions in India, could see a successful bid putting it back to the top 10 from its current position of 16. Before the recent round of M&As, India’s pharma market had only one foreign player — the UK-based GlaxoSmithKline (GSK) — among the top 10. Multinational companies, such as Pfizer, GSK and Novartis, played a dominant role in the domestic market till as recent as early-2007, but lost out to homegrown generics majors, such as Cipla, Ranbaxy and Zydus Cadilla. HDFC Securities institutional research VP Ranjit Kapadia said: “Till mid-90’s, foreign pharma firms dominated the Indian pharma industry. The introduction of the drug price control order in 1995 brought many of their drugs under price control, thus restricting their growth. At the same time, Indian pharma companies launched a slew of generic drugs outside price control, which boosted their growth.” Besides consolidation, a new patent regime will also drive the growth of foreign companies in India. Launched in 2005, the new patent laws provide patent holders exclusive marketing rights in India for 20 years. This will protect foreign pharma firms that hold patents from losing out to Indian companies that make low-cost copies of off-patent drugs.
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BASEL: Swiss pharmaceuticals company Novartis AG said on Friday it has successfully produced a first batch of swine flu vaccine weeks ahead of
expectations. The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said. The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September. Novartis said it would use the first batch of vaccine for pre-clinical evaluation and testing. It is also being considered for clinical trials, the company said. The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week. A second plant is being built in Holly Springs, North Carolina, the company said. Novartis said more than 30 governments have requested vaccine supplies, including the US Department of Health and Human Service, which placed a $289 million order in May.
expectations. The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said. The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September. Novartis said it would use the first batch of vaccine for pre-clinical evaluation and testing. It is also being considered for clinical trials, the company said. The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week. A second plant is being built in Holly Springs, North Carolina, the company said. Novartis said more than 30 governments have requested vaccine supplies, including the US Department of Health and Human Service, which placed a $289 million order in May.
Jubilant Organosys ties up with US-based Endo Pharmaceuticals
NEW DELHI: Jubilant Organosys through its Bangalore-based subsidiary Jubilant Biosys has entered into a three-year drug discovery & development
collaboration with US-based Endo Pharmaceuticals to come out with a portfolio of oncology molecules. The focus of the tie-up is to develop pre-clinical candidates for joint clinical development, a Jubilant Organosys release said. Endo will own the compounds developed under the partnership and will also be responsible for its worldwide commercialisation. Delhi-based Jubilant Organosys will receive research funding and success-based milestone payments from the American firm, besides royalties on successful commercialisation, the company statement added. Jubilant Organosys CMD Shyam Bhartia and Co-CMD Hari Bhartia in a joint statement said: “We anticipate significant rewards on successful development of compounds and its subsequent commercialisation.” While funding for research is expected to kick in from this quarter onwards, milestone linked payments for such research projects usually takes 6-9 months, subject to meeting the targets.
collaboration with US-based Endo Pharmaceuticals to come out with a portfolio of oncology molecules. The focus of the tie-up is to develop pre-clinical candidates for joint clinical development, a Jubilant Organosys release said. Endo will own the compounds developed under the partnership and will also be responsible for its worldwide commercialisation. Delhi-based Jubilant Organosys will receive research funding and success-based milestone payments from the American firm, besides royalties on successful commercialisation, the company statement added. Jubilant Organosys CMD Shyam Bhartia and Co-CMD Hari Bhartia in a joint statement said: “We anticipate significant rewards on successful development of compounds and its subsequent commercialisation.” While funding for research is expected to kick in from this quarter onwards, milestone linked payments for such research projects usually takes 6-9 months, subject to meeting the targets.
Dr Reddy's Labs gets USFDA nod for Omeprazole Mg OTC
MUMBAI: Drug manufacturer Dr Reddy’s Laboratories on Wednesday said it has received US regulatory approval for anti-heartburn capsules.
The company has received US Food and Drug Administration approval for its Abbreviated New Drug Application for Omeprazole Mg OTC, Dr Reddy’s Laboratories said in a filing to the Bombay Stock Exchange. Omeprazole Mg OTC is indicated for the treatment of heartburn. Dr Reddy’s formulation contains 20.6 mg Omeprazole Mg and the dosage form is a capsule, the filing added.
The company has received US Food and Drug Administration approval for its Abbreviated New Drug Application for Omeprazole Mg OTC, Dr Reddy’s Laboratories said in a filing to the Bombay Stock Exchange. Omeprazole Mg OTC is indicated for the treatment of heartburn. Dr Reddy’s formulation contains 20.6 mg Omeprazole Mg and the dosage form is a capsule, the filing added.
India can become a global pharma innovation hub, experts say
WASHINGTON: India has the potential to emerge as a global innovation hub and the US's collabortion with Indian pharma and health companies will not
only help the two countries, but also entire world, eminent experts and industry leaders said. Speaking in favour of the US forging collaborations with Indian firms and academic institutes in the field of biopharma and healthcare sector, Pfizer President (Global R&D) Martin Mackay said not only there is a great willingness to collaborate in India, there is a great ability of Indian companies to adapt to western needs. India can be a major centre for innovation globally said Joe Smith, Vice-President at Johnson & Johnson. J&J doesn't view India as an emerging market and felt infectious innovation can come from India, he added. William Chin, Vice-President, Discovery Research & Clinical Investigation, Eli Lilly, felt the pharma industry is under siege with flood of patent expiries, higher safety hurdles and pricing pressure. As the sector is facing the problem of managing the huge data at its disposal, Chin said India with its IT strengths can play a vital role. Lilly has moved beyond level 1 partnerships, based on cost arbitrage, to level II based on partnerships of shared rewards and risks in India. Lilly would eventually like to move towards level III partnerships based on equity stake in Indian companies to share success, he said.
only help the two countries, but also entire world, eminent experts and industry leaders said. Speaking in favour of the US forging collaborations with Indian firms and academic institutes in the field of biopharma and healthcare sector, Pfizer President (Global R&D) Martin Mackay said not only there is a great willingness to collaborate in India, there is a great ability of Indian companies to adapt to western needs. India can be a major centre for innovation globally said Joe Smith, Vice-President at Johnson & Johnson. J&J doesn't view India as an emerging market and felt infectious innovation can come from India, he added. William Chin, Vice-President, Discovery Research & Clinical Investigation, Eli Lilly, felt the pharma industry is under siege with flood of patent expiries, higher safety hurdles and pricing pressure. As the sector is facing the problem of managing the huge data at its disposal, Chin said India with its IT strengths can play a vital role. Lilly has moved beyond level 1 partnerships, based on cost arbitrage, to level II based on partnerships of shared rewards and risks in India. Lilly would eventually like to move towards level III partnerships based on equity stake in Indian companies to share success, he said.
Monday, June 8, 2009
Row over generic drugs intensifies after seizure in Germany
NEW DELHI: German authorities last month seized a large consignment of antibiotic Amoxicillin made by Chennai-based Medopharm during transit at
Frankfurt over alleged trademark infringement, in the latest incident of European Union nations interfering in legitimate trade of generic medicine. Amoxicillin is used to treat a wide range of bacterial infections. Medopharm was exporting its drugs to Republic of Vanuatu in the Pacific. The development has intensified global healthcare groups’ and Indian drugmakers’ opposition to the EU Border Measures Regulation that allows seizure of drugs during transit for alleged patent, trademark violation and counterfeit charges. “There is no valid reason for detaining these medicines especially since the name Amoxicillin is an international non-proprietary name (INN),” said a joint statement issued by five social organisations, Health Action International (HAI), Oxfam International, BUKO-pharma, Medico International and Third World Network. The consignment worth e28,000, seized on May 5, was released on May 20 after British company GlaxoSmithKline, the former patent holder for Amoxil brand of Amoxicillin, said that there was no trademark infringement. “This seizure is the latest in the list of cases that demonstrate that EU regulations are actively hampering timely access to medicines to developing countries,” it added. Last year, 17 consignments of Indian medicines were halted at the Netherlands. This year again, the Dutch authorities seized several Indian consignments, including those of Dr Reddy’s, Aurobindo and Cipla. The Frankfurt seizure was the first in Germany. The group of NGOs has asked the European Commission to take immediate steps to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.
Frankfurt over alleged trademark infringement, in the latest incident of European Union nations interfering in legitimate trade of generic medicine. Amoxicillin is used to treat a wide range of bacterial infections. Medopharm was exporting its drugs to Republic of Vanuatu in the Pacific. The development has intensified global healthcare groups’ and Indian drugmakers’ opposition to the EU Border Measures Regulation that allows seizure of drugs during transit for alleged patent, trademark violation and counterfeit charges. “There is no valid reason for detaining these medicines especially since the name Amoxicillin is an international non-proprietary name (INN),” said a joint statement issued by five social organisations, Health Action International (HAI), Oxfam International, BUKO-pharma, Medico International and Third World Network. The consignment worth e28,000, seized on May 5, was released on May 20 after British company GlaxoSmithKline, the former patent holder for Amoxil brand of Amoxicillin, said that there was no trademark infringement. “This seizure is the latest in the list of cases that demonstrate that EU regulations are actively hampering timely access to medicines to developing countries,” it added. Last year, 17 consignments of Indian medicines were halted at the Netherlands. This year again, the Dutch authorities seized several Indian consignments, including those of Dr Reddy’s, Aurobindo and Cipla. The Frankfurt seizure was the first in Germany. The group of NGOs has asked the European Commission to take immediate steps to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.
Pharma firms continue to face patent violation charges in Europe
NEW DELHI: Even after India raised concerns with EU, troubles of generic companies which export drugs to developing countries through Europe are far
from over as seizures by Dutch customs still continue. In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt. In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement. Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.) When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination. These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says. DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added. The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru. According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.
from over as seizures by Dutch customs still continue. In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt. In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement. Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.) When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination. These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says. DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added. The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru. According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.
Saturday, June 6, 2009
Fish cure has competition
HYDERABAD: As the scientific community’s chorus against the fish medicine gets shriller, Ayurvedic experts have decided to provide some stiff competition to the Bathini brothers by organising their own camp for asthma patients on June 8.
A panel of doctors from the Ayurvedic Services Trust, announced on Wednesday, that they would provide medicine to people suffering from asthma, colds and allergies.
The Ayurvedic camp would be held at Gandhi Gyan Mandir, opp Koti women’s College from 8 am to 7 pm. The patients shall be attended by a team of ayurvedic doctors, lead by Dr M P Sharma and the medicine provided will be “purely vegetarian”. It would be prepared with herbs which can be consumed with medicated water provided at the camp.
“The medicine will be more effective if taken on the auspicious day of Mrigashira Karti and if consumed after that, then it may not be that effective,” said Dr Rajender. “The main aim of conducting such a camp is to promote vegetarianism in society and helping people getting beating diseases such as asthma,” said Dr Mahesh Agarwal. The medicine is prepared as per an ancient formula and has no side-effects.
“The camp is being organised from the past 23 years and this year we are expecting more the 13,000 people,” said Dr Rajender.
After taking the medicine with medicated water, the patient shall be provided a pack of 6 tablets for the next 45 days.
“Many other social welfare organisations are also associated in this healthy cause,” said Dr Agarwal.
A panel of doctors from the Ayurvedic Services Trust, announced on Wednesday, that they would provide medicine to people suffering from asthma, colds and allergies.
The Ayurvedic camp would be held at Gandhi Gyan Mandir, opp Koti women’s College from 8 am to 7 pm. The patients shall be attended by a team of ayurvedic doctors, lead by Dr M P Sharma and the medicine provided will be “purely vegetarian”. It would be prepared with herbs which can be consumed with medicated water provided at the camp.
“The medicine will be more effective if taken on the auspicious day of Mrigashira Karti and if consumed after that, then it may not be that effective,” said Dr Rajender. “The main aim of conducting such a camp is to promote vegetarianism in society and helping people getting beating diseases such as asthma,” said Dr Mahesh Agarwal. The medicine is prepared as per an ancient formula and has no side-effects.
“The camp is being organised from the past 23 years and this year we are expecting more the 13,000 people,” said Dr Rajender.
After taking the medicine with medicated water, the patient shall be provided a pack of 6 tablets for the next 45 days.
“Many other social welfare organisations are also associated in this healthy cause,” said Dr Agarwal.
US FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug
Maryland: The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves' disease.
"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."
PTU was approved for marketing in 1947. A total of 32 cases of serious liver injury associated with the use of PTU were reported to the FDA's Adverse Event Reporting System since that system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant.
Graves’ disease is an autoimmune disorder that leads to overactivity of the thyroid gland. The thyroid gland, located in the front of the neck just below the Adam’s Apple, releases hormones that regulate the rate of the body’s metabolism and are critical for body temperature control, energy, weight, mood, and blood calcium levels.
PTU is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Because a rare birth defect has been reported with methimazole and not with PTU, PTU may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy.
"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."
PTU was approved for marketing in 1947. A total of 32 cases of serious liver injury associated with the use of PTU were reported to the FDA's Adverse Event Reporting System since that system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant.
Graves’ disease is an autoimmune disorder that leads to overactivity of the thyroid gland. The thyroid gland, located in the front of the neck just below the Adam’s Apple, releases hormones that regulate the rate of the body’s metabolism and are critical for body temperature control, energy, weight, mood, and blood calcium levels.
PTU is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Because a rare birth defect has been reported with methimazole and not with PTU, PTU may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy.
TNPCB asks Aurobindo to close Cuddalore unit for illegal production of intermediate 7-AVNA
The Tamil Nadu Pollution Control Board (TNPCB) has issued closure notice to the Aurobindo Pharma for closing its Cuddalore plant at Tamil Nadu for violation of conditions prescribed in the consent given to the Cuddalore plant. Since then, the company has closed all its activities in the plant. The TNPCB has given the company to produce the drug intermediate, 6-APA, in March 2008. But it has started producing another chemical product 7-AVNA, said S Asokan, district environment engineer (DEE), Cuddalore. He said his office has issued show cause notice to the company 15 days ago, and the chairman of TNPCB has given the closure notice on June 4.According to him, the Board has got complaints from the public that the Unit was producing a chemical product 7-AVNA. Following it, the DEE has carried out an inspection in the unit. Sources from the Board told Pharmabiz that there was clear proof that the unit has produced the chemical product in the plant. In the DEE's inspection, it was found that the unit had transported consignments of 7-AVNA on several occasions in the month of March and April this year, to other places.When the general manager of the unit at Cuddalore, S Govindan, was contacted by Pharmabiz, he said the company got permission from the Pollution Control Board to manufacture the intermediate 6-APA in March 2008. Later in the month of December the company has submitted application to the State Level Expert Appraisal Committee for change of product. "There was no market for 6-APA product, so we wanted to produce 7-AVNA. Both are intermediaries. So we started only a trial run and closed even before the inspection held. After all, there was some problem with the plant and we closed the unit one month ago. Now power shortage is also there," Govindan said.After issuing the closure notice, the Board has ordered the state electricity board to disconnect the power supply to the unit.The joint chief environmental engineer at the TNPCB, Jayakumar TC Ethiraj, said the pharma company cannot do trial run production without prior consent from the Board. There was clear evidence that the company has produced the chemical product 7-AVNA, illegally.
APDCA to spend Rs 1.39 cr for facility upgradation in 2009-10
Mumbai-The Andhra Pradesh Drug Control Administration (APDCA) will utilise Rs 1.39 crore sanctioned under the Department for International Development (DFID) programme, the international financial assistance agency of the UK, to strengthen its monitoring activities in the current financial year.The government, which sanctioned Rs 290.93 lakh and Rs 138.59 lakh in 2007-08 and 2008-09, respectively, has allocated Rs 138.59 lakh for the current financial year for the administration to collect and analyse drug samples from tribal and under-served areas and to enhance the working condition of drug control officials, according to APDCA sources. DFID, from the year 2007, has sanctioned considerable fund to improve the healthcare delivery mechanism in Andhra Pradesh.This year, the fund allocated for procurement of drug samples for analysis in tribal and under-served areas with Rs 12 lakh, mobility support for enforcement officers with Rs 40.32 lakh and improvement of communication system with Rs 5.33 lakh. An amount of Rs 29.20 lakh will be spend for strengthening of drugs control laboratory in Vijayawada including creation of Rs 10 lakh estimated training centre and Rs 50.74 lakh is allocated for computerization and net working of drugs control administration, informed R P Meena, director general, Drugs and Copyrights, Drug Control Administration, Andhra Pradesh.At present, the administration collects almost 350 samples from under-served and remote areas every month apart from regular samples of 400 samples to ensure the quality of pharmaceutical products distributed in these hard-to-reach regions. "Under the programme, communication is improved by providing cell phones to all officers and fax machines to all offices in the state. Transport facilities for officers are improved by providing 50 four-wheelers to officers," informed Meena.In the year 2007-08, under the programme, the government had released an amount of Rs 40.32 lakh for mobility of enforcement officers in remote areas. Subsequently the government has also released another Rs 40.32 lakh afresh during the year 2008-2009, under the programme. Through these funds, the administration has hired services of 62 vehicles for the enforcement officials for intensifying the raid, search and drug seizure activities. The fund will also be utilised to complete the modernisation programmes in the administration's two drug testing laboratories - at Hyderabad and Vijayawada - to be upgraded with National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation. The upgradation project has received more than Rs 10 crore in the past three financial years from DFID Programme.During the last five years, from 2004-05 to 2008-09, as many as 23287 samples have been analyzed in both the drugs control laboratories. Out of this, 454 drug samples have been found to be not of standard quality during the years. The percentage of not of quality standard drugs prevailing in the state is less than two per cent even as the national average during this period is reported as six to eight per cent. The prevalence of spurious drugs in the state is 0.21 per cent where as the national average for the same is 0.47 per cent, according to APDCA officials.
KPMG-IDMA seminar on opportunities & challenges for Indian pharma in Mumbai on June 9
Mumbai-The global consultancy firm KPMG, in collaboration with the Indian Drug Manufacturers' Association (IDMA), will organise a half day seminar on the opportunities and challenges for the Indian pharmaceutical industry in global markets on June 9, 2009 in Mumbai.The conference on 'Bringing Medicine to Global Markets - Opportunities and Challenges' is poised to provide insight on the regulatory perspectives, the price reporting methods and business challenges in various countries for the Indian pharma industry. The aim is to update the latest developments, opportunities and challenges in these markets, where the Indian companies have their business prospects active.The opening remarks will be delivered by N R Munjal, president, IDMA, Arpinder Singh, executive director, KPMG in India and Karen Harper, principal advisor, KPMG LLP by providing insight on the vision for the future of drug development, drug approval and audit methods in emerging markets. William Sarraille, partner, Sidley Austin LLP, will detail on the pharmaceutical price reporting, a must for companies operating in the United States. In the light of heavy fines levied by US for non-compliance, William Sarraille will deliver on review of VA Inspector General's requirements for written policies and procedures, methods to implement an internal audit and to face the VA's voluntary disclosure program.The challenges in developing an industry perspective global compliance program to meet the regulatory challenges and business challenges and to maintain best practices with a global overview will be elaborated by Abhiroop Gandhi, director of global compliance, Actelion Pharmaceuticals.The challenges faced by India Pharma to enter and expand operations in the regulated markets will be another topic to update the participants from the industry. The importance of developing a winning strategy, finding the right business model, managing risk/return equation and keeping a focus on the competency development for this will be elucidated by Sanjay Singh, associate director- corporate finance, KPMG India.A panel discussion on the emerging issues faced by pharma companies in India on protection of their Intellectual Property as well as FCPA and anti-bribery issues will be held following the session. The panel, consisting of V V Parsuram, vice- president - corporate governance, Dr Reddy's Lab, Adheesh Nargolkar, senior associate, AZB & Partners and Gaganpreet Singh Puri, director, KPMG in India, will also address some of the typical issues faced by pharma companies when operating in Indian Market, informed KPMG officials.
Friday, June 5, 2009
India confirms fifth case of swine flu
NEW DELHI: Health ministry has confirmed a fifth case of swine flu in a 28-year-old man who travelled from the United States through London.
The man arrived in Hyderabad on May 31 and two days later reported symptoms of fever, cold and sore throat, said a ministry statement issued late Friday. He tested positive for the virus and is in stable condition. "His close contacts are being traced and advised home quarantine and their health status is being monitored," the statement said. The World Health Organization says swine flu has reached 69 countries and infected more than 22,000 people, causing 125 deaths.
The man arrived in Hyderabad on May 31 and two days later reported symptoms of fever, cold and sore throat, said a ministry statement issued late Friday. He tested positive for the virus and is in stable condition. "His close contacts are being traced and advised home quarantine and their health status is being monitored," the statement said. The World Health Organization says swine flu has reached 69 countries and infected more than 22,000 people, causing 125 deaths.
Thursday, June 4, 2009
Panacea Biotec plans to foray European market
NEW DELHI: Vaccine maker Panacea Biotec plans to foray into the lucrative European retail market by the end of the year. The company’s Baddi plant
has received the German drug regulator’s approval and expects to get approval of three of its drugs by September this year, the company’s joint MD Rajesh Jain told ET. “Once we get the permission to sell our drug in Germany, other Euro-pean countries would expedite our applications as there is mutual rec-ognition of European regulators,“ Mr Jain added. These products are formulations medicines. Unlike the institutional international sales of vaccines, which form bulk of the company’s current Rs 800 annual sales, retail sales offer a higher margin. The company has also set up a wholly-owned subsidiary in Germany, its second in Europe after its Swiss subsidiary. However, the company expects to get a significant revenue stream from its overseas sales after three years when it will sell a larger product range in Europe and its US sales, the world’s largest drug market, kicks in. The Delhi-based company is also expected to soon apply to the US Food and Drug Administration (FDA) to sell its drugs from its Baddi plant, in Himachal Pradesh. In addition, PharmAthene Inc a US-based drug company that specialises in biodefence, in which Panacea Biotec hold 14.5% stake, is in the process of applying to the USFDA to sell its Anthrax vaccines. At present, formulations segment accounts for less than a thrid of the company’s total sales. In the last fiscal, its formulation business grew 14% at Rs 228 crore, while its vaccines sales declined to Rs 548 crore from Rs 637 crore.
has received the German drug regulator’s approval and expects to get approval of three of its drugs by September this year, the company’s joint MD Rajesh Jain told ET. “Once we get the permission to sell our drug in Germany, other Euro-pean countries would expedite our applications as there is mutual rec-ognition of European regulators,“ Mr Jain added. These products are formulations medicines. Unlike the institutional international sales of vaccines, which form bulk of the company’s current Rs 800 annual sales, retail sales offer a higher margin. The company has also set up a wholly-owned subsidiary in Germany, its second in Europe after its Swiss subsidiary. However, the company expects to get a significant revenue stream from its overseas sales after three years when it will sell a larger product range in Europe and its US sales, the world’s largest drug market, kicks in. The Delhi-based company is also expected to soon apply to the US Food and Drug Administration (FDA) to sell its drugs from its Baddi plant, in Himachal Pradesh. In addition, PharmAthene Inc a US-based drug company that specialises in biodefence, in which Panacea Biotec hold 14.5% stake, is in the process of applying to the USFDA to sell its Anthrax vaccines. At present, formulations segment accounts for less than a thrid of the company’s total sales. In the last fiscal, its formulation business grew 14% at Rs 228 crore, while its vaccines sales declined to Rs 548 crore from Rs 637 crore.
Zydus files IND application with DCGI for diabetes and obesity
AHMEDABAD: Healthcare major, Zydus Cadila has filed IND (Investigational New Drug) application for anti-diabetic and anti-obesity drug with Drugs
Controller General of India (DCGI). The drug (ZYD1) designed and developed by Zydus Research Centre is a novel candidate in the class of anti-diabetic agents known as incretin mimetics and has displayed a better efficacy and safety profile. According to the company, the anti-diabetic drug agent (incretin mimetics) is poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging the un-met medical needs that still continues to dodge the treatment and care of diabetes. The new class of drugs called incretins came to the fore in May 2005. ZYD1 has demonstrated beneficial effects in preclinical animal models on glucose reduction and added benefits of weight loss. During the preclinical studies, the new drug displayed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation. Commenting on the development, Pankaj Patel, Chairman and Managing Director, Zydus Cadila, said, “This discovery is an important achievement for us. We believe that it holds promising commercial potential as a best-in-class candidate due to un-met medical needs in the treatment of diabetes.” The number of diabetics in the world, now estimated to be 246 million and is expected to increase rapidly to 380 million in 2025. Currently 41 million (16.6%) of the diabetic population lives in India and it is expected to rise to 70 million (18.4%) by 2025. In 2025 nearly half of the world’s diabetic population will be from India, China, Brazil, Russia and Turkey. The global anti-diabetic market was estimated at $24 bn in 2008.
Controller General of India (DCGI). The drug (ZYD1) designed and developed by Zydus Research Centre is a novel candidate in the class of anti-diabetic agents known as incretin mimetics and has displayed a better efficacy and safety profile. According to the company, the anti-diabetic drug agent (incretin mimetics) is poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging the un-met medical needs that still continues to dodge the treatment and care of diabetes. The new class of drugs called incretins came to the fore in May 2005. ZYD1 has demonstrated beneficial effects in preclinical animal models on glucose reduction and added benefits of weight loss. During the preclinical studies, the new drug displayed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation. Commenting on the development, Pankaj Patel, Chairman and Managing Director, Zydus Cadila, said, “This discovery is an important achievement for us. We believe that it holds promising commercial potential as a best-in-class candidate due to un-met medical needs in the treatment of diabetes.” The number of diabetics in the world, now estimated to be 246 million and is expected to increase rapidly to 380 million in 2025. Currently 41 million (16.6%) of the diabetic population lives in India and it is expected to rise to 70 million (18.4%) by 2025. In 2025 nearly half of the world’s diabetic population will be from India, China, Brazil, Russia and Turkey. The global anti-diabetic market was estimated at $24 bn in 2008.
Adcock Angram decides not to acquire Cipla Medpro SA
Adcock Ingram has abandoned its earlier decision to acquire Cipla Medpro SA (CMSA) on account of a key suspensive condition to proposed transaction and opposition from Cipla India. During April 2009, Adcock had shown interest to make an offer to acquire the entire issued share capital of CMSA. However, the company found that there is no reasonable prospect of a key suspensive condition pertaining to the contractual relationship between Cipla India and CMSA. Commenting on the withdrawal, CEO Jonathan Louw said, "While we are disappointed to withdraw from a transaction which had such a compelling commercial rationale, we have been placed in an untenable position. Given the lack of response from the CMSA Board, the uncertainty over the precise nature of the contractual relationship between Cipla India and CMSA, and the potential risk of retributive action by Cipla India in respect of its commercial relationship with CMSA, the prospect of successfully completing a commercially viable transaction is no longer possible. We remain committed to our strategy of growing Adcock Ingram through prudent acquisition, and delivering value to shareholders." Adcock Ingram is a leading South African healthcare group. Adcock's Pharmaceutical division holds the No 1 position in OTC medicines and the No 2 position in prescription generics. Adcock has leading market shares in key segments, with two prescription brands (namely Synap Forte and Adco-Zolpidem) ranked No 1 in their respective treatment segments. In addition, Adcock has three of the top ten OTC brands: Adco-Dol, Panado and Corenza C. Adcock's Hospital Products division is South Africa's leading supplier of hospital and critical care products; these include blood systems, accessories and products used for renal dialysis.The company's press release said that the Adcock Board has repeatedly requested the CMSA Board to provide its view on the merits of the proposed transaction. Despite its public undertakings to do so, the CMSA Board has yet to respond to the merits of the Firm Intent Notice. Instead, the CMSA Board focused attention on the stated opposition of CMSA's principal supplier, Cipla India to the proposed transaction with a view to discouraging Adcock in proceeding with the proposed offer. While Adcock recognises the value of CMSA's relationship with Cipla India, Adcock has consistently maintained that it would seek the formal support of Cipla India at the appropriate time - which would be after the CMSA Board had published its views on the merits of the proposed transaction to CMSA shareholders. Adcock believes that if the CMSA Board is of the opinion that the proposed transaction represents a fair opportunity for CMSA shareholders, it would be the CMSA Board's responsibility to persuade Cipla India to reconsider its view.
Zydus, Teva end patent disputes
MUMBAI: Ahmedabad-based ZydusCadila and Israeli generic major Teva have settled their patent disputes over active pharmaceutical ingredients (APIs)
used to make generic versions of GlaxoSmithKline’s heart drug and Johnson & Johnson’s anti-psychotic drug. Zydus will now be able to sell its generic versions of these products in the US without legal implications from Teva. Teva currently controls a majority market share in these products. When contacted about the settlement and the company’s product launch in the US, a Zydus Cadila spokesperson declined to comment. Judge Garrett E Brown Jr. of the US District Court of New Jersey signed a stipulation on May 14 of dismissal, bringing an end to the claims and counterclaims of patent infringement and federal antitrust law violations in a lawsuit over two of Teva’s patents related to blood pressure and congestive heart failure treatment Coreg.
GlaxoSmithKline makes the heart drug Coreg, while Johnson & Johnson makes the antipsychotic drug Risperdal. Teva had filed a case against Zydus over the patent that Teva had for preparing a chemical compound Carvedilol — a pharmaceutical compound used in the treatment of congestive heart failure. It is the API used in the product sold by GSK under the trade name Coreg. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. Annual sales of Risperdal were approximately $2.6 billion in the US for the year ended March 31, 2008. In 2006, just before it went off-patent, Coreg grossed revenues of £195 million for GSK. Teva currently controls a majority share in this market, closely with GSK. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. The dispute had centred on Zydus’s alleged infringement of Teva’s patents relating to Carvedilol, the active ingredient in Coreg. In its complaint, Teva said it attempted to obtain information on the composition and processes the company intended to use in May 2007, but Zydus declined to produce the samples, forcing it to file its lawsuit on October 12, 2007. In the case of Risperidone, Zydus had submitted a motion to transfer the case to the US District Court for the Eastern District of Virginia, which it later withdrew. Zydus had sued Teva in the court for violating antitrust laws and deceiving the Patent and Trademark Office in the US in obtaining the patents for preparation of Risperidone
used to make generic versions of GlaxoSmithKline’s heart drug and Johnson & Johnson’s anti-psychotic drug. Zydus will now be able to sell its generic versions of these products in the US without legal implications from Teva. Teva currently controls a majority market share in these products. When contacted about the settlement and the company’s product launch in the US, a Zydus Cadila spokesperson declined to comment. Judge Garrett E Brown Jr. of the US District Court of New Jersey signed a stipulation on May 14 of dismissal, bringing an end to the claims and counterclaims of patent infringement and federal antitrust law violations in a lawsuit over two of Teva’s patents related to blood pressure and congestive heart failure treatment Coreg.
GlaxoSmithKline makes the heart drug Coreg, while Johnson & Johnson makes the antipsychotic drug Risperdal. Teva had filed a case against Zydus over the patent that Teva had for preparing a chemical compound Carvedilol — a pharmaceutical compound used in the treatment of congestive heart failure. It is the API used in the product sold by GSK under the trade name Coreg. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. Annual sales of Risperdal were approximately $2.6 billion in the US for the year ended March 31, 2008. In 2006, just before it went off-patent, Coreg grossed revenues of £195 million for GSK. Teva currently controls a majority share in this market, closely with GSK. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. The dispute had centred on Zydus’s alleged infringement of Teva’s patents relating to Carvedilol, the active ingredient in Coreg. In its complaint, Teva said it attempted to obtain information on the composition and processes the company intended to use in May 2007, but Zydus declined to produce the samples, forcing it to file its lawsuit on October 12, 2007. In the case of Risperidone, Zydus had submitted a motion to transfer the case to the US District Court for the Eastern District of Virginia, which it later withdrew. Zydus had sued Teva in the court for violating antitrust laws and deceiving the Patent and Trademark Office in the US in obtaining the patents for preparation of Risperidone
Sun Pharma to spend Rs 332 cr in R&D
NEW DELHI: Sun Pharmaceuticals, India's biggest drug company by market capitalisation, will spend Rs 332 crore in research & development of
low-cost version of original drugs to be sold in domestic and global markets, a top company executive said. The Mumbai-based drug maker had last year spent Rs 290 crore on R&D activities. In an analysts call on Monday, the company's chairman and managing director Dilip Shanghvi said the firm will file 30 ANDA applications with the US Food and Drug Administration (FDA) before March 2010. ANDA or abbreviated new drug applications are filed by generic drug makers to sell their low-cost copies of original drugs sold in the US.
Last year, the Mumbai-based company and its American subsidiary Caraco Pharma got approval to sell nine products in the US, Mr Shanghvi added. Drug development for riskier new products is done through the company's subsidiary Sun Pharma Advanced Research Company (SPARC). Sun Pharma's research team of 500 scientists will focus on its core strengths - cardiology, psychiatry, neurology and gastroenterology segments. The investments will be used to develop active pharmaceutical ingredients, the basic chemical used in a medicine, for both domestic and international market, besides the ANDA applications to the US, the world's largest drug market. Mr Shanghvi said it was not possible to give a potential earnings estimate from the US, where it has 108 pending applications, because revenue of such drugs are dependent on multiple factors. More than a third of the company's sales come from the US. Due to an ongoing regulatory hurdle at its Detroit facility the company's sales from the US market has dropped significantly and was partly responsible for global sales declining 10% to Rs 1,134 crore for the quarter ended March 31, 2009. The company, which reported revenues of Rs 4,272 crore for 2008-09, expects its sales to grow 13-15% this year, if the rupee-dollar exchange rate remains constant at the current level of Rs 48.
low-cost version of original drugs to be sold in domestic and global markets, a top company executive said. The Mumbai-based drug maker had last year spent Rs 290 crore on R&D activities. In an analysts call on Monday, the company's chairman and managing director Dilip Shanghvi said the firm will file 30 ANDA applications with the US Food and Drug Administration (FDA) before March 2010. ANDA or abbreviated new drug applications are filed by generic drug makers to sell their low-cost copies of original drugs sold in the US.
Last year, the Mumbai-based company and its American subsidiary Caraco Pharma got approval to sell nine products in the US, Mr Shanghvi added. Drug development for riskier new products is done through the company's subsidiary Sun Pharma Advanced Research Company (SPARC). Sun Pharma's research team of 500 scientists will focus on its core strengths - cardiology, psychiatry, neurology and gastroenterology segments. The investments will be used to develop active pharmaceutical ingredients, the basic chemical used in a medicine, for both domestic and international market, besides the ANDA applications to the US, the world's largest drug market. Mr Shanghvi said it was not possible to give a potential earnings estimate from the US, where it has 108 pending applications, because revenue of such drugs are dependent on multiple factors. More than a third of the company's sales come from the US. Due to an ongoing regulatory hurdle at its Detroit facility the company's sales from the US market has dropped significantly and was partly responsible for global sales declining 10% to Rs 1,134 crore for the quarter ended March 31, 2009. The company, which reported revenues of Rs 4,272 crore for 2008-09, expects its sales to grow 13-15% this year, if the rupee-dollar exchange rate remains constant at the current level of Rs 48.
Taro acquisition may cost Sun Pharma Rs 1,000 crore
NEW DELHI: Indian drug firm Sun Pharma may have to shell out up to Rs 1,000 crore this fiscal for acquiring Israel-based Taro Pharmaceuticals.
"If we are able to get all the shares of Taro Pharmaceuticals, including promoters shares, then the total cost would be up to Rs 1,000 crore," Sun Pharmaceutical Industries Chairman Dilip Shanghvi said at conference call today. And without promoters' shareholdings, it could be anywhere between Rs 200 crore and Rs 1,000 crore, he added. Sun Pharmaceutical has around a 36 per cent stake in Taro and is waiting for the Supreme Court of Israeli's nod to close the open offer. Sun Pharma and Taro had entered into a USD 454-million merger agreement in May 2007 which was unilaterally terminated by Taro alleging under valuation. After this, both companies had filed suits against each other and later Sun Pharma launched the open offer to acquire additional shares of the Israeli firm.
The Indian pharma company had commenced an open offer at a price of USD 7.75 per share in June last year through its subsidiary to acquire all shares of Taro, which was again challenged by the Israeli firm and the court prohibited Sun from closing the offer until it gave a verdict on the issue. Sun Pharma had extended the expiry date of the open offer for the 10th time in a row.
"If we are able to get all the shares of Taro Pharmaceuticals, including promoters shares, then the total cost would be up to Rs 1,000 crore," Sun Pharmaceutical Industries Chairman Dilip Shanghvi said at conference call today. And without promoters' shareholdings, it could be anywhere between Rs 200 crore and Rs 1,000 crore, he added. Sun Pharmaceutical has around a 36 per cent stake in Taro and is waiting for the Supreme Court of Israeli's nod to close the open offer. Sun Pharma and Taro had entered into a USD 454-million merger agreement in May 2007 which was unilaterally terminated by Taro alleging under valuation. After this, both companies had filed suits against each other and later Sun Pharma launched the open offer to acquire additional shares of the Israeli firm.
The Indian pharma company had commenced an open offer at a price of USD 7.75 per share in June last year through its subsidiary to acquire all shares of Taro, which was again challenged by the Israeli firm and the court prohibited Sun from closing the offer until it gave a verdict on the issue. Sun Pharma had extended the expiry date of the open offer for the 10th time in a row.
FDA reviewing Ranbaxy corrective action plan
NEW DELHI: The US health regulator Food and Drug Administration (FDA) is working on a corrective action plan submitted by Ranbaxy Laboratories
after 30 medicines of the company manufactured at two of its plants in India were banned from exporting to America. "The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective," US FDA spokesperson Christopher C Kelly said in a response to an e-mailed query. "(The) FDA received the Corrective Action Operating Plan (CAOP) from Ranbaxy on May 18, 2009. The CAOP is currently under review by the Center for Drug Evaluation and Research's Office of Compliance," the regulator said. The next steps will be dependent on the actions identified on the CAOP, it added. Ranbaxy's new CEO Atul Sobti on Sunday said that the company has submitted a corrective plan to the US FDA. The US health regulator on September last year had banned the import of 30 generic drugs, manufactured at company's plants located in Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh, alleging fraudulent practice.
after 30 medicines of the company manufactured at two of its plants in India were banned from exporting to America. "The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective," US FDA spokesperson Christopher C Kelly said in a response to an e-mailed query. "(The) FDA received the Corrective Action Operating Plan (CAOP) from Ranbaxy on May 18, 2009. The CAOP is currently under review by the Center for Drug Evaluation and Research's Office of Compliance," the regulator said. The next steps will be dependent on the actions identified on the CAOP, it added. Ranbaxy's new CEO Atul Sobti on Sunday said that the company has submitted a corrective plan to the US FDA. The US health regulator on September last year had banned the import of 30 generic drugs, manufactured at company's plants located in Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh, alleging fraudulent practice.
Nafdac Seizes N32 Million Fake Anti-Malarial Drugs
Nigeria: The National Agency for Food and Drug Administration and Control (NAFDAC), has foiled an attempt to import into the country a consignment of fake and adulterated antimalarial drugs Maloxine and Amalar tablets with an estimated street value of N32.1 million.
Officials of the agency, working on a tip-off, intercepted the container load of the fake drugs as it was about to be cleared at the Phase IV Kirikiri Lighter Terminal, Lagos, on Wednesday May 20, 2009.
Director General, NAFDAC, Dr. Paul Orhii, said the interception of the fake drugs may have saved hundreds of thousands of Nigerians from possible effects such as treatment failure, drug resistance, complications like anaemia and death had the drugs been circulated into the open market.
Orhii, who spoke in Lagos yesterday, added that a clearing agent who was trying to clear the consignment had been arrested while the case is currently being investigated by the agency.
He said the agency swung into action immediately it obtained a text message on the evening of the day from an informant that a company with an address at Tejuosho Street, Yaba, Lagos, imported a container load (1 x 20FT) of Maloxine tablet but was declared as seal tape (cellotape).
"Within 24hours, NAFDAC located the said container with number PCIU 2184458 at the terminal and a A 100 per cent physical inspection of the content revealed it contained 348,000 tablets of Maloxine in sachets of three tablets each, contained in 6,960 boxes packed in 960 cartons with Batch No: EM-396 and manufacturing and expiring dates 04/2008 and 03/2011 respectively.
It also contained 294,000 sachets of Amalar packed as three tablets each, contained in 5,880 boxes packed in 196 cartons with Batch No: ARTP 0053 and manufacturing and expiring dates of January 2007 and January 2010 respectively."
Orhii was emphatic that although the labels on the products indicated they were manufactured in India, the bill of lading showed the port of loading to be Xingang in China, and the exporter as Heihe Cheng Feng Trading co, Ltd. (Shenzhen Shenghetai Trading Co. Ltd).
Laboratory tests by the agency showed that the fake antimalarials which were produced in China but labelled "Made in India," contained only sulfadioxine and no pyrimethamine.
"The implications of using these fake drugs include treatment failure, drug resistance as the malaria parasite will develop immunity towards these drugs, complications like anaemia and death if no effective drug is given thereafter.
"If these fake drugs were not intercepted by NAFDAC, 642,000 adults will be affected. This figure will go up if children are given half or quarter dose as some parents and guardians sometimes do that," he added.
Calling on all Nigerians to be alert and report any suspected fake drug, unwholesome food and any other substandard regulated product, the NAFDAC boss urged all and sundry to always purchase their drugs from licensed pharmacies and other authorised outlets and to ensure all purchases are receipted.
Officials of the agency, working on a tip-off, intercepted the container load of the fake drugs as it was about to be cleared at the Phase IV Kirikiri Lighter Terminal, Lagos, on Wednesday May 20, 2009.
Director General, NAFDAC, Dr. Paul Orhii, said the interception of the fake drugs may have saved hundreds of thousands of Nigerians from possible effects such as treatment failure, drug resistance, complications like anaemia and death had the drugs been circulated into the open market.
Orhii, who spoke in Lagos yesterday, added that a clearing agent who was trying to clear the consignment had been arrested while the case is currently being investigated by the agency.
He said the agency swung into action immediately it obtained a text message on the evening of the day from an informant that a company with an address at Tejuosho Street, Yaba, Lagos, imported a container load (1 x 20FT) of Maloxine tablet but was declared as seal tape (cellotape).
"Within 24hours, NAFDAC located the said container with number PCIU 2184458 at the terminal and a A 100 per cent physical inspection of the content revealed it contained 348,000 tablets of Maloxine in sachets of three tablets each, contained in 6,960 boxes packed in 960 cartons with Batch No: EM-396 and manufacturing and expiring dates 04/2008 and 03/2011 respectively.
It also contained 294,000 sachets of Amalar packed as three tablets each, contained in 5,880 boxes packed in 196 cartons with Batch No: ARTP 0053 and manufacturing and expiring dates of January 2007 and January 2010 respectively."
Orhii was emphatic that although the labels on the products indicated they were manufactured in India, the bill of lading showed the port of loading to be Xingang in China, and the exporter as Heihe Cheng Feng Trading co, Ltd. (Shenzhen Shenghetai Trading Co. Ltd).
Laboratory tests by the agency showed that the fake antimalarials which were produced in China but labelled "Made in India," contained only sulfadioxine and no pyrimethamine.
"The implications of using these fake drugs include treatment failure, drug resistance as the malaria parasite will develop immunity towards these drugs, complications like anaemia and death if no effective drug is given thereafter.
"If these fake drugs were not intercepted by NAFDAC, 642,000 adults will be affected. This figure will go up if children are given half or quarter dose as some parents and guardians sometimes do that," he added.
Calling on all Nigerians to be alert and report any suspected fake drug, unwholesome food and any other substandard regulated product, the NAFDAC boss urged all and sundry to always purchase their drugs from licensed pharmacies and other authorised outlets and to ensure all purchases are receipted.
Spurious drugs seized in Panchkula (Himachal pradesh,india)
Panchkula: Following the arrest of Sandeep Kumar, a partner of the industry found manufacturing spurious drugs in the Industrial Area, the drug controller department seized huge quantity of medicines, energy drinks and raw material to manufacture medicines, including food colours, essence labels and machinery, here today.
A team of drug control department, headed by assistant drug controller GL Singhal, sealed the unit last Friday when the partners of the firm did not reach at the premises despite they were informed about the presence of officials outside the locked factory. Other team members were Rajinder Harna, SDCO Karnal; C P Aaggarwal, SDCO, Ambala: Lalit Goel, DCO, Yamuna Nagar & Parjinder Singh, DCO, Ambla.
The officials, however, after waiting for several hours, returned after sealing the unit that day.
Today a team of Rajasthan police, however, raided the house of Sandeep at Rajpura and arrested him for manufacturing the spurious drugs.
The police officials from Rajasthan said spurious drugs manufactured by Sandeep were found being sold at Ganga Nagar in the month of March. Following the investigations they raided the house of Sandeep and seized 35 boxes of amoxycilin from his house. However, Sandeep could not be arrested, said the police.
Sandeep, who was present on the spot, said he was a property dealer when his friend Sunny Papneja contacted him to start this business. Sunny was employed at a pharma unit at Panchkula he said. Thereafter both of them, after obtaining a licence under food product manufacturing from municipal council, started manufacturing here in a portion of plot No. 315 at the Industrial Area II.
Assistant drug controller Singhal said while the accused had no license to manufacture drugs, all medicines and other products were being manufactured under unhygienic conditions.
A team of drug control department, headed by assistant drug controller GL Singhal, sealed the unit last Friday when the partners of the firm did not reach at the premises despite they were informed about the presence of officials outside the locked factory. Other team members were Rajinder Harna, SDCO Karnal; C P Aaggarwal, SDCO, Ambala: Lalit Goel, DCO, Yamuna Nagar & Parjinder Singh, DCO, Ambla.
The officials, however, after waiting for several hours, returned after sealing the unit that day.
Today a team of Rajasthan police, however, raided the house of Sandeep at Rajpura and arrested him for manufacturing the spurious drugs.
The police officials from Rajasthan said spurious drugs manufactured by Sandeep were found being sold at Ganga Nagar in the month of March. Following the investigations they raided the house of Sandeep and seized 35 boxes of amoxycilin from his house. However, Sandeep could not be arrested, said the police.
Sandeep, who was present on the spot, said he was a property dealer when his friend Sunny Papneja contacted him to start this business. Sunny was employed at a pharma unit at Panchkula he said. Thereafter both of them, after obtaining a licence under food product manufacturing from municipal council, started manufacturing here in a portion of plot No. 315 at the Industrial Area II.
Assistant drug controller Singhal said while the accused had no license to manufacture drugs, all medicines and other products were being manufactured under unhygienic conditions.
FICCI to organize India-focused activities on clinical trial at DIA annual meet in US
Mumbai: The Federation of Indian Chamber of Commerce and Industry (FICCI) is organizing India-focused activities for promoting Indian clinical trial industry in the upcoming 45th annual DIA meeting from June 21 to 25 at San Diego, US. The main objective of the programme is to highlight the progress made by Indian clinical research industry, the enabling role of the government and showcase the services offered by the companies complying the GCP and best practices that exist in the clinical research arena.
The DIA annual meeting is the biopharmaceutical industry's largest global, multidisciplinary event, features the biggest names from industry, regulatory and academia.
A delegation of senior government officials and industry is expected to be led by the secretary, department of pharmaceuticals Ashok Kumar along with joint secretary, department of pharmaceuticals Devendra Chaudhary, joint secretary, Ministry of Health & family welfare Debashish Panda, advisor, department of biotechnology Dr T S Rao and Drugs Controller General of India Dr Surinder Singh.
As an update on the Indian clinical research environment, the FICCI - E&Y Knowledge Paper would be unveiled at the DIA along with the Indian industry directory for distribution in the DIA.
DIA sources said that this will be an impetus for the clinical trial industry in the country as this is for the first time that the Indian clinical trial industry gets government support towards its promotion abroad.
On June 23, a roundtable discussion and networking dinner reception with participation from government (India & US) and industry (India, US and other countries participating in the DIA) will see discussions on the ethical practices in India and capacity and capability building efforts.
On June 24, the DIA session on Global Clinical Trials: Destination India, will see the Indian government officials highlighting the enabling role of the government. Senior government officials and others are expected to deliver speeches in the session.
The DIA annual meeting is the biopharmaceutical industry's largest global, multidisciplinary event, features the biggest names from industry, regulatory and academia.
A delegation of senior government officials and industry is expected to be led by the secretary, department of pharmaceuticals Ashok Kumar along with joint secretary, department of pharmaceuticals Devendra Chaudhary, joint secretary, Ministry of Health & family welfare Debashish Panda, advisor, department of biotechnology Dr T S Rao and Drugs Controller General of India Dr Surinder Singh.
As an update on the Indian clinical research environment, the FICCI - E&Y Knowledge Paper would be unveiled at the DIA along with the Indian industry directory for distribution in the DIA.
DIA sources said that this will be an impetus for the clinical trial industry in the country as this is for the first time that the Indian clinical trial industry gets government support towards its promotion abroad.
On June 23, a roundtable discussion and networking dinner reception with participation from government (India & US) and industry (India, US and other countries participating in the DIA) will see discussions on the ethical practices in India and capacity and capability building efforts.
On June 24, the DIA session on Global Clinical Trials: Destination India, will see the Indian government officials highlighting the enabling role of the government. Senior government officials and others are expected to deliver speeches in the session.
Sunday, May 31, 2009
India poised to be next global petri dish
The good news is that science is in vogue. According to the India Science Report, 2005, nearly one-fourth of Indians who qualified at the
graduate level had a background in science. Further, as per the National Science Survey 2004, around 3/4th of the respondents felt that science and technology was vital for education. The C in the PCM group of subjects at high school chemistry offers lot of scope in the industry today. According to career counsellors, a specialisation in chemistry opens up avenues in the areas of clinical research, environmental sciences, food technology and leather industry. After IT and ITES, India is soon poised to be the global petri dish. According to industry estimates, the market for clinical research activities is expected to touch $two billion by 2010. Spiralling R&D costs and rising overheads are forcing many global pharmaceutical majors to outsource clinical research to India. Not only that, even Indian pharmaceutical majors have moved out from reverse engineering to new drug discovery (NDD). This, in turn, provides ample career opportunities for chemists and analysts. "Clinical research organisations are on the lookout for people qualified in biochemistry," says Arun Bhat, president, ClinInvent. The starting salaries for a clinical research analyst (CRAs) is anywhere between Rs 2 lakh and Rs 3 lakh per annum.
The next in the hierarchy are senior clinical research analyst, clinical team leader, clinical study manager, project manager, and so on. According to a senior official from Orchid Chemicals and Pharmaceuticals: "An under-graduation in chemistry is not enough. Its a must to have a Phd if one aspires to be a group leader." "Chemistry offers career scope in the field of environmental sciences. With numerous chemicals polluting the environment, companies across the globe are looking at ways and means of containing such pollutants," says educational counsellor Kalavathi Amarachelvam. And, with working couples becoming the norm, the dependance on processed foods is higher than before and these contain certain natural and chemicals. This in turn offers career opportunities for young graduates.
graduate level had a background in science. Further, as per the National Science Survey 2004, around 3/4th of the respondents felt that science and technology was vital for education. The C in the PCM group of subjects at high school chemistry offers lot of scope in the industry today. According to career counsellors, a specialisation in chemistry opens up avenues in the areas of clinical research, environmental sciences, food technology and leather industry. After IT and ITES, India is soon poised to be the global petri dish. According to industry estimates, the market for clinical research activities is expected to touch $two billion by 2010. Spiralling R&D costs and rising overheads are forcing many global pharmaceutical majors to outsource clinical research to India. Not only that, even Indian pharmaceutical majors have moved out from reverse engineering to new drug discovery (NDD). This, in turn, provides ample career opportunities for chemists and analysts. "Clinical research organisations are on the lookout for people qualified in biochemistry," says Arun Bhat, president, ClinInvent. The starting salaries for a clinical research analyst (CRAs) is anywhere between Rs 2 lakh and Rs 3 lakh per annum.
The next in the hierarchy are senior clinical research analyst, clinical team leader, clinical study manager, project manager, and so on. According to a senior official from Orchid Chemicals and Pharmaceuticals: "An under-graduation in chemistry is not enough. Its a must to have a Phd if one aspires to be a group leader." "Chemistry offers career scope in the field of environmental sciences. With numerous chemicals polluting the environment, companies across the globe are looking at ways and means of containing such pollutants," says educational counsellor Kalavathi Amarachelvam. And, with working couples becoming the norm, the dependance on processed foods is higher than before and these contain certain natural and chemicals. This in turn offers career opportunities for young graduates.
Only the bad times are good for pharma
The one good thing about a potential global pandemic is that it puts drugmakers in an extremely favourable light. Even if the dangers of swine flu are not as dire as first thought, it is comforting to know agents like Tamiflu and Relenza exist and that governments around the world are buying them.
Pharmaceutical situations where everyone is happy are rare. Companies hitherto seen as money-grabbing and disease-mongering are suddenly acknowledged as saviours, using their expertise to protect the public from unknown and possibly fatal threats. Scientists go into over-drive, manufacturing capacity is notched up a few gears, distributors are busy, shareholders are cockahoop. The only people sidelined are those in marketing because when something is really needed it doesn't need selling.
In that scenario is a painfully simple truth: that what people want from the pharmaceutical industry is products that don't need selling. People want things that work. And what is true for vaccines against viruses the human world has never seen is true for all pharmaceuticals. People want things that make them better. They don't want to pay for them. They don't want side-effects. Ideally, they don't even want to know they are taking them. The bottom line is they don't really want to acknowledge they need them.
This widespread blindness to the fact that people do age, get sick and, heaven forbid, die, has far-reaching consequences for the industry. It puts enormous pressure on governments and insurance companies to pay truly astronomical monopoly prices to give people suffering from cancer a few weeks, perhaps months, of life. These premium prices accelerate the innovation mill to the extent there are now 861 new cancer drugs and vaccines in human trials or awaiting approval by the FDA. Whether those governments and insurance companies are able to pay for the products that are approved remains to be seen.
On another level, this quest to be fixed, whatever the cost, can be seen in nurses being employed to text overweight patients on their mobile phones to remind them to take their obesity pills. Or in the UK's NHS providing smokers with alternative means of maintaining their nicotine addiction in patches and chewing gum at prices that are set in line with tobacco and it's associated high taxes to help people stop people smoking in the first place.
Because people so much want to be made better, the distribution of healthcare resources is highly illogical. Palliative care workers and cancer surgeons would love just a fraction of the money that is poured into cancer drugs. And just about anyone would benefit from the healthcare resources spent urging people to take pills to help them lose weight (one would think they could do this for themselves), or maintain a nicotine habit that allows people to continue puffing in private and chewing in public.
Not only are they illogical but some think they are also not fair. In a recent CNN interview former US president Bill Clinton was not the first to point out that US drug prices are significantly higher than anywhere else. "At our AIDS clinic down the street here in Harlem, the taxpayers pay $10,000 a year to treat people with the big pharmaceutical companies' AIDS medicine," he said. "That medicine costs about $3,500 a year in Canada and Europe, countries with per capita incomes as high as America."
As the US grapples with how to absorb no less than 46 million uninsured Americans into state-funded programmes, different conclusions are drawn from the fact that everyone else pays lower prices than they do. Some, for example, insist it is because no-one else (except New Zealanders) can advertise direct to consumers; others think that everyone else freeloads on the back of Americans, who pay the lion's share of R&D costs. What no-one mentions is the propensity of a culture to take medicine and, with that, all the implications about how responsible people are for their individual health, how much they want to be fixed, and what they will allow (television advertising, for example) to make that fix as widely available as possible.
Cultural factors also go some way to explaining how the World Health Organisation can show Cubans and Americans expecting to live roughly the same number of healthy life-years while the former pay just over $225 a year for their healthcare and the latter more than $5,000.
Cultural or lifestyle factors are hard for healthcare systems to deal with, because, as said, people, generally speaking, just want to be made better as imperceptively as possible with products that work, that don't need advertising, that don't cost an arm and a leg and don't draw attention to the fact they are ill, fat, old, dying or any other condition they don't want to face up to and properly acknowledge. Which is why, in the normal course of events, they only view the industry positively when something like a global pandemic looms on the horizon.
Pharmaceutical situations where everyone is happy are rare. Companies hitherto seen as money-grabbing and disease-mongering are suddenly acknowledged as saviours, using their expertise to protect the public from unknown and possibly fatal threats. Scientists go into over-drive, manufacturing capacity is notched up a few gears, distributors are busy, shareholders are cockahoop. The only people sidelined are those in marketing because when something is really needed it doesn't need selling.
In that scenario is a painfully simple truth: that what people want from the pharmaceutical industry is products that don't need selling. People want things that work. And what is true for vaccines against viruses the human world has never seen is true for all pharmaceuticals. People want things that make them better. They don't want to pay for them. They don't want side-effects. Ideally, they don't even want to know they are taking them. The bottom line is they don't really want to acknowledge they need them.
This widespread blindness to the fact that people do age, get sick and, heaven forbid, die, has far-reaching consequences for the industry. It puts enormous pressure on governments and insurance companies to pay truly astronomical monopoly prices to give people suffering from cancer a few weeks, perhaps months, of life. These premium prices accelerate the innovation mill to the extent there are now 861 new cancer drugs and vaccines in human trials or awaiting approval by the FDA. Whether those governments and insurance companies are able to pay for the products that are approved remains to be seen.
On another level, this quest to be fixed, whatever the cost, can be seen in nurses being employed to text overweight patients on their mobile phones to remind them to take their obesity pills. Or in the UK's NHS providing smokers with alternative means of maintaining their nicotine addiction in patches and chewing gum at prices that are set in line with tobacco and it's associated high taxes to help people stop people smoking in the first place.
Because people so much want to be made better, the distribution of healthcare resources is highly illogical. Palliative care workers and cancer surgeons would love just a fraction of the money that is poured into cancer drugs. And just about anyone would benefit from the healthcare resources spent urging people to take pills to help them lose weight (one would think they could do this for themselves), or maintain a nicotine habit that allows people to continue puffing in private and chewing in public.
Not only are they illogical but some think they are also not fair. In a recent CNN interview former US president Bill Clinton was not the first to point out that US drug prices are significantly higher than anywhere else. "At our AIDS clinic down the street here in Harlem, the taxpayers pay $10,000 a year to treat people with the big pharmaceutical companies' AIDS medicine," he said. "That medicine costs about $3,500 a year in Canada and Europe, countries with per capita incomes as high as America."
As the US grapples with how to absorb no less than 46 million uninsured Americans into state-funded programmes, different conclusions are drawn from the fact that everyone else pays lower prices than they do. Some, for example, insist it is because no-one else (except New Zealanders) can advertise direct to consumers; others think that everyone else freeloads on the back of Americans, who pay the lion's share of R&D costs. What no-one mentions is the propensity of a culture to take medicine and, with that, all the implications about how responsible people are for their individual health, how much they want to be fixed, and what they will allow (television advertising, for example) to make that fix as widely available as possible.
Cultural factors also go some way to explaining how the World Health Organisation can show Cubans and Americans expecting to live roughly the same number of healthy life-years while the former pay just over $225 a year for their healthcare and the latter more than $5,000.
Cultural or lifestyle factors are hard for healthcare systems to deal with, because, as said, people, generally speaking, just want to be made better as imperceptively as possible with products that work, that don't need advertising, that don't cost an arm and a leg and don't draw attention to the fact they are ill, fat, old, dying or any other condition they don't want to face up to and properly acknowledge. Which is why, in the normal course of events, they only view the industry positively when something like a global pandemic looms on the horizon.
Friday, May 29, 2009
Sanofi pulls out of race for Shantha; GSK in fray
NEW DELHI: British drug major GlaxoSmithKline Pharmaceuticals is in advanced talks to buy at least a 51% stake from French company Merieux Alliance
in Shantha Biotech after the other contender, Sanofi Aventis, dropped out of the race, two persons privy to the development said.
“Only a few matters relating to the valuation need to be finalised,” a senior industry executive said, asking that neither his name nor that of his company be revealed. Sanofi Aventis is understood to have come to the conclusion that the privately-held company’s product portfolio was not attractive enough for it to proceed with negotiations, one of them said. France’s Merieux Alliance bought a 60% stake in Shantha Biotech in 2006 and subsequently increased it to about 80%. GSK is interested in buying at a majority stake in Shantha Biotech and shore up its vaccine business, especially the five-in-one pentavalent variety where it has lost out to rivals such as Panacea Biotec, Novartis and Shantha Biotech, a senior industry executive said.
The pentavalent vaccine protects infants from diphtheria, whooping cough, tetanus, hepatitis-B and the Haemophilus influenzae type b bacterium which causes diseases such as pneumonia and meningitis. While the size of a potential deal is not known, the French owners are seen estimating the value of Shantha Biotech at Rs 1,000-1,200 crore. In March, ET had reported that GSK and Sanofi Aventis were in the fray to buy the company. A Merieux spokeswoman said, “Merieux Alliance has been contacted many times by different international vaccine companies. There is nothing new on this topic and Merieux Alliance has no comments to add.” A GSK India spokesman said the company did not “comment on market speculation”. The original promoter KI Varaprasad Reddy, who is also the firm’s MD, owns about a 17% stake. Mr Reddy said he was not aware of any likely deal, terming the development a “rumour”. Shantha Biotech, whose sales are estimated to be around Rs 200 crore, shot into fame in 1997 after it became the first Indian firm to develop and market a recombinant Hepatitis B vaccine. It employs over 700 people and markets a range of vaccines in India and global markets. It also provides contract research and manufacturing services and has a wholly-owned subsidiary in the US. The proposed deal demonstrates the changing business dynamics in the global drug industry which is increasingly expanding into the generics business to maintain revenues. Indian drug companies are experts in making low-cost versions of blockbuster drugs. Shantha Biotech also provides low-cost manufacturing and research hub.
in Shantha Biotech after the other contender, Sanofi Aventis, dropped out of the race, two persons privy to the development said.
“Only a few matters relating to the valuation need to be finalised,” a senior industry executive said, asking that neither his name nor that of his company be revealed. Sanofi Aventis is understood to have come to the conclusion that the privately-held company’s product portfolio was not attractive enough for it to proceed with negotiations, one of them said. France’s Merieux Alliance bought a 60% stake in Shantha Biotech in 2006 and subsequently increased it to about 80%. GSK is interested in buying at a majority stake in Shantha Biotech and shore up its vaccine business, especially the five-in-one pentavalent variety where it has lost out to rivals such as Panacea Biotec, Novartis and Shantha Biotech, a senior industry executive said.
The pentavalent vaccine protects infants from diphtheria, whooping cough, tetanus, hepatitis-B and the Haemophilus influenzae type b bacterium which causes diseases such as pneumonia and meningitis. While the size of a potential deal is not known, the French owners are seen estimating the value of Shantha Biotech at Rs 1,000-1,200 crore. In March, ET had reported that GSK and Sanofi Aventis were in the fray to buy the company. A Merieux spokeswoman said, “Merieux Alliance has been contacted many times by different international vaccine companies. There is nothing new on this topic and Merieux Alliance has no comments to add.” A GSK India spokesman said the company did not “comment on market speculation”. The original promoter KI Varaprasad Reddy, who is also the firm’s MD, owns about a 17% stake. Mr Reddy said he was not aware of any likely deal, terming the development a “rumour”. Shantha Biotech, whose sales are estimated to be around Rs 200 crore, shot into fame in 1997 after it became the first Indian firm to develop and market a recombinant Hepatitis B vaccine. It employs over 700 people and markets a range of vaccines in India and global markets. It also provides contract research and manufacturing services and has a wholly-owned subsidiary in the US. The proposed deal demonstrates the changing business dynamics in the global drug industry which is increasingly expanding into the generics business to maintain revenues. Indian drug companies are experts in making low-cost versions of blockbuster drugs. Shantha Biotech also provides low-cost manufacturing and research hub.
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