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.
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