Weekly Roundup: August 27, 2007
- McKinsey Sees Indian Drug Industry at US$20bn By 2015 (India)
- Analysis: Four Major Drugmakers Likely to Top FY07 Earnings Forecasts (Japan)
- Novartis to Move Indian R&D (India)
- New Zealand Bans Larger Doses of Arthritis Drug Prexige, Cites Liver Damage Risk (New Zealand)
- Bayer Anticipates High-speed Growth After Merger (China)
- Ajanta Out-Licenses Product to Taiwan Firm (India)
- Eisai Pushes For Development Of Cancer Drugs (Japan)
- Ranbaxy Labs Mulls Testing Unit Spin-off (India)
- Reforms in Pharma on Snail Pace (India)
- Drug Regulator to Monitor Side Effects (India)
- WHO To Help Fast-Track Improvements In China Products Regulation (China)
- Cadila Pharma Looks for Acquisitions in Europe, US (India)
- World Courier Launches China Cold Chain Network (China)
McKinsey Sees Indian Drug Industry at US$20bn By 2015 (India) Global consulting firm McKinsey forecasts the Indian pharmaceutical market tripling by 2015, from the current $6.5 billion to $20 billion. According to McKinsey's latest report, titled, "India Pharma 2015: Unlocking the Potential of the Indian Pharmaceuticals Market," the sector will grow by 12% annually for the next few years. One key driver for the expected market growth in India is the doubling of disposable income and an increase in the number of middle-class households. Several other factors will play a key role in the growth of the pharmaceutical market, including large private sector investments in health infrastructure, an increase in the number of physicians, greater penetration of health insurance, the rising prevalence of chronic diseases, and aggressive market penetration by smaller companies. However, concerns over drug pricing policies and product patent regulations could threaten the expected growth. McKinsey's report suggests that while the present generics industry will continue to dominate the Indian pharmaceutical market, patented products will constitute close to 10 percent of the market in the next ten years. (Click here for more ) Analysis: Four Major Drugmakers Likely to Top FY07 Earnings Forecasts (Japan) Earnings for Japan's top four pharmaceutical companies are already expected to exceed annual projections. This prediction is made based on surprisingly strong first quarter performances by Takeda Pharmaceutical Co., Astellas Pharma Inc., Daiichi Sankyo Co., and Eisai Co. In fact, Daiichi Sankyo has already achieved 43 percent of its forecasted pretax profit for the year, while Takeda, Astellas, and Eisai have made 33 percent, 29 percent, and 25 percent respectively. Healthy international sales, combined with a relatively weak yen, have been the major cause of the booming profit margins. Takeda's biggest overseas earner was Actos, a diabetes medication. Astellas got a boost from Prograf, which prevents organ rejection. And Eisai's success largely stemmed from Aricept, its anti-Alzheimer's drug. Even if the yen does get stronger, it is unlikely it will have much effect on the earnings of these companies. This factor leads experts to believe all four companies will probably raise their expected annual earnings after announcing figures for the first half of the year in October. (Click here for more - May Require Paid Subscription) Novartis to Move Indian R&D (India) Swiss pharmaceutical firm Novartis plans to move hundreds of millions of dollars in planned investments from India in the next few years in response to a court's rejection of the company's attempt to protect the patent on the cancer medicine Glivec, a ruling that weakens intellectual property rights on new medicines. Daniel Vasella, chief executive of Novartis, said, "This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It's not a punishment, it's just a question of the culture for investment." India has enjoyed an upturn in investment by some pharmaceutical companies after tougher patent rules were introduced in 2005, matched by strong market growth and the presence of skilled and affordable doctors and researchers. However, other international drug makers have made larger investments elsewhere in places like China and Singapore, due to stronger legal protection. In the Glivec case, the court said that "incremental innovation" did not qualify the drug as a new chemical entity justifying protection. Novartis says such an interpretation violates World Trade Organization agreements and will be a disincentive for investment, because much pharmaceutical innovation occurs through incremental research. Vasella says he has no plans for a fresh appeal against the latest court ruling, stating that it is a matter for the WTO. (Click here for more - May Require Paid Subscription) New Zealand Bans Larger Doses of Arthritis Drug Prexige, Cites Liver Damage Risk (New Zealand) New Zealand's medicine watchdog Medsafe has imposed a ban on the supply of high-level doses of the pain relief drug Prexige, which has been linked to an increased risk of liver damage. The government agency has ordered the withdrawal of 200 milligram and 400 milligram doses of Prexige tablets, produced by Swiss pharmaceutical company Novartis AG. The agency says that the 100 milligram dose tablets would stay on the market, though their use would be closely monitored. The anti-inflammatory drug was withdrawn in Australia after it was blamed for the deaths of two people and for triggering liver failure that required two others to have transplants. Medsafe spokesman Stewart Jessamine says its medicines adverse reactions committee discussed the overall risks and benefits of the use of Prexige with regulators in Australia, Singapore and Britain. It "concluded that the data for higher doses of lumiracoxib, the active ingredient in Prexige, support an association with liver damage that was greater than that seen for other anti-inflammatory medicines," he says. "This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200 milligram and 400 milligram dose," Jessamine adds. Sheldon Jones, a spokesman for Novartis in Switzerland, said, "We're continuing to work with the health authorities about the recent information." (Click here for more - May Require Free Registration) Bayer Anticipates High-speed Growth After Merger (China) Bayer Schering Pharmaceuticals China expects to maintain growth of over 30 percent in the market, as the merger of the healthcare units of Bayer and Schering nears completion. Liam Condon, managing director of Bayer Healthcare China and chief of Bayer Schering Pharmaceuticals China, reports Bayer Schering saw growth of about 50 percent in 2005 and is targeting a further 30 to 50 percent this year. "Our business scale (this year) will be much larger than last year's for sure," says Condon. U.S. healthcare industry research company IMS Health says that China's pharmaceutical market will grow by 14.4 percent this year. The Chinese pharmaceutical market is shifting focus from antibiotics to treatment for cancers, cardiovascular and cerebrovascular diseases, and diabetes. Bayer Schering also plans to introduce more of its blockbuster medicines to the Chinese market. (Click here for more ) Ajanta Out-Licenses Product to Taiwan Firm (India) India-based drug maker Ajanta is currently bucking the market trend of in-licensing foreign pharmaceuticals for production in India. Instead, Ajanta is out-licensing its anti-scar drug Vanzia to Taiwan-based Orient Europharma. Under the contract the drug will be marketed by Orient in Singapore, Macau, Hong Kong, and Malaysia, as well as Taiwan. Ajanta has also agreed to sell manufacturing technology to the drug in exchange for an up-front cash payout, and further revenue sharing. (Click here for more) Eisai Pushes For Development Of Cancer Drugs (Japan) Eisai Co. is accelerating its development of antibody drugs, hoping to leverage the technologies of U.S. subsidiary Morphotek Inc. to spur growth in the field of cancer treatment. Morphotek plans to begin by December phase II clinical testing of MORAb-009, an antibody that recognizes and binds to a cell-surface protein called mesothelin, which is strongly associated with the spread of cancer. The Eisai subsidiary is conducting safety and efficacy tests on MORAb-009 to treat pancreatic cancer, mesothelial cancer, small-cell lung cancer and ovarian cancer. The company will also start phase I clinical trials in fiscal 2008 for two other antibody drugs for cancer treatment: MORAb-028 to treat metastatic melanoma and MORAb-004 to prevent the formation of blood vessels that supply nutrients to tumors. (Click here for more - May Require Paid Subscription) Ranbaxy Labs Mulls Testing Unit Spin-off (India) Ranbaxy Laboratories Ltd, India's second largest drugmaker, has invested heavily in research and development (R&D). The company is considering options such as spinning off the testing and development services part of its R&D facility into a separate company and partnering a leading clinical trials firm. Ranbaxy "is in talks with a few multinational players in the drug development business to set up a joint venture company that will undertake development services of Ranbaxy as well as similar projects from outside," according to an unidentified person familiar with the situation. Another proposed option is to expand Ranbaxy's partnership model in core drug discovery research. Ranbaxy signed a multi-year agreement with global drug maker GlaxoSmithKline Plc. for drug discovery research earlier this year, and hopes to forge similar partnerships with other firms. "This will help reducing dependence on the parent company to sustain high-cost R&D and will also optimize utilization of the already created infrastructure," the person said. Ranbaxy's off-patent or generic drugs R&D pipeline has about 88 drug applications pending with the FDA, approximately 20 first-to-file generic drug candidates that can be commercialized soon, and four new drug compounds at various development stages. (Click here for more ) Reforms in Pharma on Snail Pace (India) India-based pharmaceutical companies are calling on government officials to reform the country's price control policy. They claim the government does not take into account the costs of packaging when establishing price restrictions on drugs. Drug manufacturers say without this consideration, it is not cost effective to produce packaging necessary to discourage the sale of substandard imitation drugs. This leaves pharmaceutical companies with a major dilemma. They can either foot the cost of packaging or risk a glut of fraudulent drugs flooding the market. Representatives for India's pharmaceutical companies worry that to avoid this quandary some manufacturers will stop making price controlled products. Unfortunately, the 75 drugs on India's price controlled list, like Iron and Vitamin A supplements, are necessary for the health of the country's population. (Click here for more ) Drug Regulator to Monitor Side Effects (India) The Central Drugs Standard Control Organisation (CDSCO), the Indian drug regulator, is planning a major overhaul in the country's drug adverse reaction monitoring system. A team of approximately 100 clinical pharmacologists across the country will be appointed to collect adverse drug reaction reports and patient complaints from hospitals, clinics, and practicing clinicians. The drug review system typically works through collecting adverse reaction reports and analyzing them in the context of safety, efficacy, and dosage compliance. It is now being proposed as a regular procedure to keep a close watch on all approved drugs in the post-marketing phase. "Though US FDA frequently publishes drug reviews and follow-up actions (recalls or restricted-use notifications) on its website, such moves are still unheard of in India," says C.J. Shishoo, trustee, Consumer Education and Research Centre, a consumer action group. According to Dr Shishoo, at least half a dozen drugs with questionable safety profiles are still being marketed in India as there were no adverse reports available with the regulator. According to a senior official from the CDSCO, "currently our mechanism is grossly inadequate to tackle the issues related to pharmacovigilance as there are no public interaction systems wherein the doctors or patients can (share) their experiences with drugs that they use (with) the regulator directly. Since the department is also facing severe people crunch, it is not able to dedicate special cells or people with the task of collecting patient responses." (Click here for more ) WHO To Help Fast-Track Improvements In China Products Regulation (China) The World Health Organization is working to fast-track improvements of food and products regulation in China, whose exports have become a source of safety concern in recent months. "The Food and Safety department of the World Health Organization in Geneva has been working with the government of China to streamline their regulation of food and products," WHO Director-General Dr. Margaret Chan said. Chan announced a special experts meeting in Beijing scheduled for mid-September. "The government of China is committed to improving their system," she added. In an effort to regain consumer confidence, a Cabinet-level panel announced last week the launch of a nationwide safety campaign focused on food and drugs, as well as increased monitoring of exports. (Click here for more - May Require Paid Subscription) Cadila Pharma Looks for Acquisitions in Europe, US (India) Cadila Pharmaceuticals Ltd. is one of India's leading drug manufacturers. The company has also already put down roots in America, Africa, Central and South-East Asia, Japan, Middle East and Europe. Cadila is now looking for acquisitions within regulated international markets that will help it better cultivate its brand across the globe. It is specifically targeting companies with established pharmaceutical or biotechnology products. Cadila's hope is to close a deal that will allow it the same penetration of regulated markets as it already enjoys in its production of generic drugs within unregulated markets in India and several parts of Africa. (Click here for more ) World Courier Launches China Cold Chain Network (China) World Courier has expanded its cold shipping services, used for biological specimens and investigational drugs, to 36 major Chinese cities, with cold chain transport services and supplies to every clinical trial location currently approved by the Chinese State Food and Drug Administration. Henning Voss, director for World Courier, North Asia said, "China is poised to become the fourth largest pharmaceutical market by 2012. With our new operational network in place, we look forward to helping pharmaceutical companies, central labs and clinical research organizations improve their supply chain efficiencies in this vital, but complex country." (Click here for more )
India Infoline (08/23/07)
Nikkei Weekly (08/21/07) Oku, Takashi
Financial Times (08/21/07) Jack, Andrew
International Herald Tribune (08/20/07)
China Daily (08/21/07) Baijia, Liu
livemint.com (08/20/07) Unnikrishnan, C.H.
Nikkei Weekly (08/24/07)
livemint.com (08/23/07) Unnikrishnan, C.H.
Economic Times of India (08/19/07)
livemint.com (08/26/07)
Asian Wall Street Journal (08/23/07)
Business Standard (India) (08/21/07) Dutta, Vishal
China Economic Review (08/07) Powell, Gareth
