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December 27, 2007

Semiweekly Roundup: Dec. 27, 2007

Japan To Compensate Hepatitis C Victims, Leave Drug Makers Liable (Japan)
The Japanese government plans to enact legislation early in the new year to compensate some of an estimated 1,000 patients infected with hepatitis C after being given tainted blood products. The proposed bill would let the courts decide who would be eligible, as well as the fate of drug makers responsible for the suspect blood products. Under the bill being discussed by legislators, government compensation would be confined to patients given fibrinogen and hemostatic agents, but not to those infected through transfusions. Prime Minister Yasuo Fukuda apologized in person to four of the 200 people who filed suits. (Click here for more )

“Ruling Parties Debate HCV Bill Details”
Yomiuri Shimbun (Japan) (12/27/07)

High Cost Of Research Leads MNCs To Shanghai-Based WuXi Pharmatech (China)Thanks to moves by multinational pharmaceutical companies, Shanghai-based WuXi Pharmatech is expected to have more chemists on its staff than the world’s largest drug maker, Pfizer. Pfizer and other MNCs look to WuXi for research that could lead to a possible blockbuster drug for them as they face a need to reduce costs, in part by trimming personnel levels. That has allowed WuXi to flourish to the extent it was able to transform itself into a public company whose market value has doubled in four months. CEO Ge Li acknowledges the company exists because of excessive research costs elsewhere. (Click here for more )

“WuXi Has More Chemists Than Pfizer As Shanghai Research Surges”
Bloomberg (U.S.) (12/27/07)

AstraZeneca Loses Bid For India Patent On New Prilosec Formulation (India)
Indian authorities have denied AstraZeneca a patent for a new formulation of its Prilosec (omeprazole) drug for treating ulcers. Indian drug maker Torrent Pharma had filed opposition to the patent. The Delhi patent office said it rejected the patent requiest because the new formulation did not provide enhanced therapeutic efficacy to the already-patented formulation. Generics of the drug have been available in India for several years. (Click here for more )

“AstraZeneca Denied Patent For Anti-Ulcer Drug”
Economic Times (India) (12/27/07)

India Pharma Looks To Research, Drug Discovery To Make Rosy 2008 (India)
Many of India’s drug makers see 2008 as a promising year for them and their decision to focus on discovering new drugs and doing research for multinationals. The chairman of Nicholas Piramal India says foreign pharmas finally have realized Indian companies have those capabilities. The realization came near the end of 2007, however, so the Indian industry depended on mergers and acquisitions strategies that largely failed to be fruitful. Indian pharmaceuticals did benefit in 2007 from increased sales in the domestic market. (Click here for more )

"Pharma Set For Small Buys In ’08”
Hindustan Times (India) (12/26/07)

China State Council Approves Plan To Encourage Drug Innovation (China)
China’s Cabinet approved a technological project aimed at encouraging independent innovation and industrial competitiveness in the manufacturing of pharmaceuticals. The drug project, one of three approved by the State Council, is aimed at treatments and preventatives for serious diseases and discovery of key drugs. The council said it adopted the project in the interests of providing safe, effective and affordable medical products. The other two projects involved telecommunications and water pollution control. (Click here for more )

“Telecom, Drug Plans Approved”
China Daily (Xinhua) (12/26/07)

China Taking Greater Steps To Reduce Cost Of Key Drugs (China)
China’s Health Ministry plans to create an independent system for production, procurement and distribution of basic drugs as part of a medical reform proposal presented to the legislature. Health Minister Chen Zhu told the Standing Committee of the National People’s Congress that the government should play a bigger role in medical care and public health service. He suggested greater government responsibility and input in such things as ensuring safer and cheaper drugs. He noted a lack of government funding has led medical institutions to rely on profits from medical services and prescriptions, driving up the prices for both, and said the ministry would reduce hospital involvement in drug sales. (Click here for more )

“China Outlines Medical Reform Plan”
China Daily (12/26/07)

Chinese Middle Class Shuns Western Drugs In Favor Of Traditional Medicine (China)
Western drug makers are finding China’s middle class a tough sell even though Chinese in that group are fans of U.S. cars and Starbucks. They still confine their drug spending to an average $10 a year, compared with the $900 American average. The Chinese middle class is as large as the entire U.S. population, but drug makers who have invested more than $1 billion in China the past 15 years have had little success in cracking the Chinese preference for traditional local medicine based on ingredients in plants. China also prohibits direct-to-consumer advertising for prescription drugs. (Click here for more )

“Global Pharma MNCs Find China Tough”
Economic Times (India) (12/26/07)

Taiwan Women’s Activists Challenge Marketing Effort For Gardasil (Taiwan)
Women’s rights activists accused Merck, Sharpe & Dohme of giving women misleading information in an effort to market its Gardasil, the only vaccine available against human papillomavirus. The head of Taiwan Women’s Link said the vaccine protects against only certain HPV virus strains and is not a substitute for regular pap smears, yet it is marketed as “three shots protecting you for life.” At a news conference, it was noted some gynecologist offices offered tickets to see a popular singer and gave a Gardasil sales pitch to those who sought the tickets. The vaccinations are not publicly funded, but the Department of Health is considering coverage. (Click here for more )

“Women’s Groups Scrutinize HPV Vaccine Marketing”
Taipei Times (Taiwan) (12/26/07)

Japan Health Panel Finds No Causal Link Between Tamiflu, Abnormal Behavior (Japan)
Researchers at Japan’s Ministry of Health, Labor and Welfare found no causal link between Roche’s anti-flu drug Tamiflu (oseltamivir phosphate) and incidents of abnormal behavior. The group surveyed physicians and relatives of 10,000 flu patients 18 years old and younger, and found 79.3 percent of them took the drug. The survey disclosed symptoms of abnormal behavior in 9.7 percent of patients given Tamiflu and 22 percent of those who did not take the drug. The leader of the researchers cautioned no conclusion could be made until the results are analyzed further. (Click here for more )

“Analysis Shows No Causal Link Between Tamiflu, Abnormal Behavior”
Japan Today (12/26/07)

Indian Drug Makers Fire Back At Rebelling Sales Reps (India)
Indian drug makers are retaliating against sales representatives who accused them of exploitation and violations of government price caps. The Indian Drug Manufacturers Association, comprising more than 650 medium-size and small drug makers, has asked the Labor minister to reclassify the sales reps as “workmen” rather than as “medical representatives” considered a part of a company’s management team. The proposed change is supported by the Organisation of Pharmaceutical Producers of India representing about 100 MNCs and Indian research-based pharmas. The Federation of Medical and Sales Representatives Associations of India also has been trying to get the government to govern their working conditions, such as requiring work days no longer than eight hours. (Click here for more )

“Drug Firms, Salesmen On Collision Course”
Business Standard (India) (12/26/07)

Vaccine Discoveries Drive India’s Biotech Industry (India)
India’s biotechnology companies count on the vaccines end of their business to drive the rest of their work in developing therapeutics, diagnostics and other segments. The vaccines segment accounts for more than 70 percent of biotech work in the country, increasing at a rate of more than 30 percent a year, reaching the $3 billion mark by 2010. The biotechs rely heavily on public institutions to do early-stage research, such as producing cell lines, so the companies can focus on process and clinical development. That trend was begun by Shantha Biotechnic’s work in developing a hepatitis B vaccine based on earlier work by the Centre for Cellular and Molecular Biology. (Click here for more )

“Discovery-Led Innovation Driving Biopharma”
Business Standard (India) (12/25/07)

Vietnam Counts 20 Percent Increase In Foreign Pharmas Operating There (Vietnam)
The number of foreign pharmaceutical companies operating in Vietnam grew by nearly 20 percent this year, the first after the nation acceded to World Trade Organization rules. The head of the Vietnam Pharmaceutical Management Bureau said the number of foreign firms grew from 312 to 370 this year, with India now accounting for 81 of the total. Korea and China were next, but most of the companies are considered no larger than medium-size. The bureau also said drugs made in India and Korea accounted for 58 percent of the country’s medicine imports, but they also accounted for most of the 19 drugs pulled from the market because of quality violations. (Click here for more )

“Pharmaceutical Firms Thriving As Prices Climb”
Vietnam Economy (12/24/07)

Chinese Bird Flu Vaccine For Humans Clears Phase II Trials (China)
Sinovac Biotech said its bird flu vaccine for use in humans has passed Phase II clinical trials without affecting any of the 402 participants. Zhang Jiansan, vice-general manager of the Beijing-based firm, said the test results indicate the vaccine could offer several choices for treatment. The executive also said the nation is capable of producing an appropriate quantity of the vaccine should it be needed. Zhang said the company was able to control the dosage and immunity procedure for the vaccine during the trials, adding to enhanced scientific and effective methods for combating the disease. (Click here for more )

“China’s Human-Use Bird Flu Vaccine ‘Safe’ And ‘Effective’”
Xinhua (China) (12/24/07)

Probe Ordered Into India Patent For Roche’s Valcyte (India)
India’s controller general ordered an investigation of a decision by the patent office in Chennai to grant F. Hoffman-LaRoche a patent for its Valcyte (valganciclovir hydrochloride) for HIV/AIDS infection developed during organ transplants. The patent office granted the patent to the Swiss drug maker without hearing opposition by a patient group, as required by law. A Mumbai lawyers group filed a pre-grant opposition last year, but the Chennai office granted the patent to Roche in September without a hearing on the group’s filing. The group challenged the patent on grounds Roche relied on a pre-1995 molecule, and thus could not have received a patent under Indian law that says only post-2005 drugs are eligible for patent protection. (Click here for more )

“Controller Orders Inquiry Into Chennai Office Patent For Roche”
Livemint (India) (12/22/07)

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