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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.