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    Shanghai Pharma applies for license to produce Tamiflu 11/2/2005
        Swiss drug company Roche is assessing an application sent by a Shanghai pharmaceutical company for a licence to produce Tamiflu. 

        With the spread of bird flu prompting high demand for the antiviral medication Tamiflu, Shanghai Pharmaceutical Group Co Ltd (SPG) submitted a written application for the license. 

        If approved, SPG will be the first Chinese company to produce Tamiflu, which according to tests is effective against bird flu in humans. 

        "We made the application in view of the growing demand for the drug and its high price," said Huang Yanzheng, vice-president of SPG. 

        Developed by Hoffmann-La Roche Inc and Gilead Sciences, Tamiflu received government approval in October 1999. In pill or liquid form, the drug is now available in about 80 countries around the world. 

        But given the worldwide shortage of the medication, the Swiss drug-maker was criticized because it would not give up its patent, which is reportedly protected until 2016, and only recently voiced willingness to work with others to produce it.

        Currently all Tamiflu in China is imported through Shanghai Roche Pharmaceutical Ltd. 

        Priced at 298 yuan (US$37) per 10 granules, the drug is now being purchased only through the government, an indicator of stringent supply. 

        Domestically produced Tamiflu could be as much as 30 per cent cheaper than imports, said Zhou Qianjun, a doctor with Shanghai No 1 People's Hospital. 

        "Yet domestic consumers might not benefit from the saved cost as there is the possibility that SPG will monopolize the business," Zhou added. 

        Roche headquarters will carry out an intensive evaluation of SGP's capabilities, including its raw materials, facilities and processes, Xu Chao, corporate communications manager of Roche's Shanghai office, said yesterday. 

        SGP is gearing up for the coming evaluation, said Huang. Declining to reveal more details, he said: "I will be able to provide better answers in two to three weeks." 

        The application came after a verbal exchange between the top management of the two companies when Roche's Chairman and Chief Executive Officer Franz Humer paid a visit to Shanghai last week. 

        Humer revealed during his trip that Roche was in talks with a number of Chinese authorities about jointly producing Tamiflu to boost its global production, amid fears supplies will fall short of what is needed in case of a flu pandemic. 

        But the Ministry of Health denied on Monday that it held negotiations with Roche recently. 

        The company expects to increase production tenfold by mid-2006, according to Roche's Shanghai office. 

        China reported 50 bird flu outbreaks last year, but no humans were infected by the virus, authorities said. 

        Since autumn this year, the H5N1 bird flu strain has been reported in Central China's Hunan Province, East China's Anhui Province and Inner Mongolia Autonomous Region. 

         (Source: China Daily)
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