PharmAsia News: Weekly Roundup: November 26, 2007

Thailand's Low-Cost Generic Drugs Scheme a Boon for Poor (Thailand)

Activists have praised Thailand for its recent decision to issue compulsory licenses for life-saving medications. These compulsory licenses temporarily remove patent protections on brand-name drugs. By doing so, Thailand will be able to import and produce less-expensive versions of these medications. Activists say Thailand is setting an example for developing nations who want to ensure quality healthcare for their citizens. Other countries, including Brazil, have already taken steps to institute similar programs. Major pharmaceutical companies have protested the Thai government's move arguing it is a violation of their intellectual property rights. However, experts say Thailand's actions are within the bounds of international law. So far, the country has issued compulsory licenses for the heart medication Plavix as well as AIDS treatments Kaletra and Efavirenz. Already generic versions of these drugs are flowing in from major Indian generics producers. In addition, the Thai government has announced it is also considering suspending patents for four cancer treatments. (Click here for more )

"Thailand's Low-Cost Generic Drugs Scheme a Boon for Poor"
MedIndia (11/24/07)

Astellas to Spend Another Y40bn on Buybacks This Fiscal Year (Japan)

Astellas Pharma Inc. reports it will spend as much as 40 billion yen to buy back up to 8 million of its own shares, or about 1.54 percent of those outstanding, this fiscal year. The drugmaker has ample cash on hand, and is facing a pressing need to manage its assets more efficiently. The plan means that Astellas will have bought more than 16 million of its own shares in the current fiscal year ending March 2008. Its treasury stock would surpass 20 million, or approximately 4 percent of outstanding shares. The company's policy is to keep treasury stock at around 1 percent to 2 percent of outstanding shares, so it will probably retire more than 10 million shares, possibly next year. The firm's shareholders have been demanding that it use its funds more efficiently. (Click here for more - May Require Paid Subscription)

"Astellas to Spend Another Y40bn on Buybacks This Fiscal Year"
Nikkei Weekly (11/23/07)

Small Cap: Bionics to Test Anti-Cancer Drug on Humans (Australia)

Biotechnology company, Bionomics Limited, will soon initiate clinical trials of a new cancer treatment in Australia. The company's Nov. 22 announcement comes on the heels of the approval of its Investigational New Drug application by the U.S. FDA. The application will also pave the way for further clinical tests of the experimental drug in both Australia and the United States. As a result of the announcement, South Australia-based Bionomics saw its shares rise 7 percent. The new treatment, called BNC105, employs a cancer-fighting method designed to destroy tumors by cutting off their blood supply. BNC105 is just one of Bionomics experimental cancer treatments. In addition to cancer research, the company has also started drug discovery and development programs for multiple sclerosis, anxiety and epilepsy. (Click here for more )

"Small Cap: Bionics to Test Anti-Cancer Drug on Humans"
Australasian Investment Review (11/22/07)

Chugai Pharmaceutical to Run 3 Domestic Plants Instead of 2 (Japan)

Chugai Pharmaceutical Co. has decided to continue operating one of its plants in Japan it was initially planning to close, saying it will run three plants instead of two. The Tokyo-based pharmaceutical maker, part of the Roche Holding AG group, announced in 2005 it would concentrate its domestic production facilities into two plants from five plants. However, it has now decided not to close its Tokyo plant, which the company discovered has a longer-than-expected lifespan for the production of biological products. (Click here for more - May Require Paid Subscription)

"Chugai Pharmaceutical to Run 3 Domestic Plants Instead of 2"
Nikkei Weekly (11/22/07)

Big Risks From Quick Drug Trials (Australia)

Australian clinical drug trials must be approved by an ethics committee, which was formed in 1991 in an attempt to speed up the drug research and development process. Before that, all trials had to be approved by the Therapeutic Goods Administration. The committee has dramatically cut approval time from three years to three months. The quick approval process allowed over 3,000 clinical sites to be registered for trials last year. The Australian drug industry invests about $520 million a year on research and development. Approximately 90 percent of that money goes to clinical trials. In addition, many large U.S.-based pharmaceutical companies have also been attracted to the Australian R&D market. But critics worry the system may be too lax. Although there have been no major problems in Australia, health and safety regulations have been under increased scrutiny around the globe. Last year six healthy volunteers in England died during a drug trial, highlighting the risks of a clinical trial system that is largely self-regulating. (Click here for more )

"Big Risks From Quick Drug Trials"
Sydney Morning Herald (Australia) (11/20/07) Ryle, Gerard

China Pharma Q3 Revenue Hits $8.3 Million (China)

China Pharma Holdings Inc. announced third quarter revenues of $8.3 million, up more than 65 percent from the same period a year ago. Net income was up 80.73 percent to $3.08 million. China Pharma has primarily focused on the discovery, development, manufacturing and marketing of drugs and supplements in China's growing pharmaceutical market. The company's distribution network spans over 29 provinces and autonomous regions around the country. (Click here for more )

"China Pharma Q3 Revenue Hits $8.3 Million"
China Knowledge (11/19/07)

Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials (China)

Sinovac Biotech has reported no serious adverse events from the Phase I and Phase II clinical trials for its vaccine designed to prevent the deadly H5N1 strain of bird flu. Sinovac had been given official approval to conduct the trials in April by the China State Food and Drug Administration. The first Phase II trial tested the vaccine on 401 patients ranging in age from 18 to 65. All participants were given either a 5 ug, 10 ug, or 15 ug dose of the vaccine. The second Phase I and Phase II trials divided 160 volunteers ranging from age three to 70 into four age groups. The same dosing rules applied to these groups with the addition of a 30 ug dose. Sinovac has also announced it will soon be reporting its official financial results for the third quarter. The Chinese company, which specializes in developing vaccines, already has treatments approved for Hepatitis A and B as well as normal influenza. (Click here for more )

"Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials"
Xinhua News Agency (11/19/07)

MIT and India to Create Health Science and Technology Institute (India)

MIT and the government of India's Department of Biotechnology has launched a partnership that will result in the creation of a new Translational Health Science and Technology Institute (THSTI) in India. This new institute, which will be modeled after the Harvard-MIT Division of Health Sciences and Technology (HST), will include faculty from multiple disciplines and professions, offer degrees through multidisciplinary programs, and develop strong ties with other institutions. Funded by the Indian government, the Indian HST will be a multidisciplinary, multiprofessional research and training center that is highly interconnected with regional centers of excellence. The institute will increase India's capacity for translating scientific and technological advancements into medical innovations that have the potential to improve healthcare both in India and around the world. To foster a culture of innovation in THSTI, HST will help recruit and train new THSTI faculty members. Each year starting in September 2008 and continuing until 2011, four recruited THSTI faculty fellows will join the HST faculty. These faculty fellows will train at HST for two years. During their stay they will develop translational research programs, design courses and curricula for THSTI, and develop close relationships with HST faculty and students. (Click here for more )

"MIT and India to Create Health Science and Technology Institute"
Business Wire (11/19/07)

U.S. Big 3 Look for New Indian Drug Suppliers (India)

Large U.S. drug wholesalers plan to outsource their requirements from upcoming Indian manufacturers, a move that will provide competition to such leading Indian drug manufacturers as Ranbaxy, Dr Reddy's, Sun Pharma, Lupin and Zydus Cadila, who have benefited tremendously from sales in the U.S. market. At least ten tier-II and tier -III Indian pharmaceutical companies with plants in Mumbai, Ahmedabad, and Hyderabad that are approved, or may be approved by the U.S. FDA, are reportedly on the radar of distributors McKesson Corporation, Cardinal Health, and AmerisourceBergen. These three wholesalers control nearly all the entire drug distribution market in the U.S.
McKesson and Cardinal Health have reportedly sent executives to India to assess the capabilities of these companies. "It is difficult for any Indian company to do business with the U.S. without the big three who control over 90 per cent of the US drug market," said Sujay Shetty, associate director, PricewaterhouseCoopers. "India has the maximum US FDA approved plants outside the US and it is natural for them to look at India for new opportunities." India has a share of approximately 23 percent in the total abbreviated new drug applications approvals and 48 percent of the drug master filings with the U.S. FDA. The United States is the largest generics market, with 28 percent of global generic sales. This is expected to hit $94 billion by 2010 and drugs worth $65-70 billion are going off-patent in the next 4-5 years, according to research reports by Crisil Research and SSKI Investment. The move by wholesalers is aimed at tapping cost-effective generic manufacturers directly, increasing the supply base across the world. (Click here for more )

"U.S. Big 3 Look for New Indian Drug Suppliers"
Business Standard (India) (11/17/07)

Manipal Group Sets Up Stem Cell Arm in Malaysia (Malaysia)

Stempeutics Research Pvt. Lab recently disclosed plans to open a subsidiary in Malaysia. The startup will be dubbed Stempeutics Research Malaysia Sdn Bhd. Stempeutic's parent company, the India-based Manipal Education and Medical, will invest between $6 million and $10 million in Stempeutics Malaysia over the next three years. Manipal will also use Stempeutics Malaysia as a jumping off point for research and commercialization in Taiwan and Singapore. Manipal has already invested $7 million in Stempeutics for the company's stem cell research program. Stempeutics is currently researching the prospect of using adult stem cells to treat a number of ailments, including myocardial infarction, multiple sclerosis, limb ischemia and cerebral stroke. Adult stem cells come in two forms. The first are autologous stem cells that are harvested from the patient's own bone marrow. Stempeutics is already conducting several clinical trials into the possible benefits of these stem cells. The company is also waiting for approval from the Indian Council of Medical Research to conduct trials with allogenic stem cells. This type of adult stem cell comes from non-related donor cells. Allogenic stem cells have the benefit of being produced on a large scale. Manipal plans to invest $5 million over the next two years to build a cell manufacturing plant in India. (Click here for more )

"Manipal Group Sets Up Stem Cell Arm in Malaysia"
LiveMint (11/16/07) Singh, Seema

Healthcare Sector Woos Investors (China)

China's health care sector is quickly emerging as a hot new target for foreign investors. Venture Capital firm FAV predicts that China will have the sixth-ranked health care market in the world by 2010. FAV also projects an industry turnover worth over $28 billion by that year. The growing market is being fueled by an aging population and an overall economic growth rate averaging between 8 percent and 9 percent since 1978. Domestic researcher ChinaVenture says health care venture capital investment rose to $31 million for the third quarter. That figure is up almost 200 percent from the second quarter of 2007. The healthy inflow of cash into the sector has also encouraged seven initial public offerings by Chinese health care companies in foreign markets so far this year. Despite the growing market, analysts say the industry can still be a risky investment, particularly when it comes to pharmaceutical research. However, insiders point out that Chinese drug companies have the advantage of an efficient drug approval system and lower R&D costs. (Click here for more )

"Healthcare Sector Woos Investors"
China Daily (11/12/07) Xing, Wang

Pharma Firms Seek to List R&D Arms, but Funding Risks Remain (India)

A number of large Indian drug makers are preparing to list their research and development sectors as a separate unit on the India stock exchange. Both Nicolas Piramal India Ltd. And Ranbaxy Laboratories have been vocal about the likelihood of listed R&D units in their futures. This move may not be the best course of action, according to KPMG International's John Morris. In his opinion, the Indian stock market is not mature enough to provide companies with the $100 million to $200 million in funding they are going to need. According to KPMG estimates Indian drug companies will spend $500 million on research and development by 2010 and $1.2 billion by 2015. He says Indian companies looking to raise that kind of major cash should look to private equity investors. He suggests partnerships with funds in West Asia or Russia might be particularly profitable. Another option, according to Morris, is to partner with large international pharmaceutical companies. Whether he is correct remains to be seen. So far, Sun Pharma Advanced Research Ltd. is the only research unit posted on the Bombay Stock Exchange. Currently, the company is trading at Rs83.25, 4.48 percent below its initial public offering price. (Click here for more )

"Pharma Firms Seek to List R&D Arms, but Funding Risks Remain"
LiveMint (11/12/07) Shrivastava, Bhuma

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November 26, 2007

Weekly Roundup: November 26, 2007

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