Drug manufacturers begin trial runs on generic Tamiflu

        After scientists from the ROC National Health Research Institutes (NHRI) claimed to have succeeded in creating a generic version of the antiviral drug Tamiflu Oct. 21, several Taiwanese manufacturers of generic drugs began trial production of the medication under the auspices of the NHRI in preparation for mass production for commercial purposes.

        NHRI researchers expressed optimism that once a license to manufacture is obtained and a sufficient supply of raw materials collected, the island's generic drug makers would be ready to mass-produce stockpiles of Tamiflu within five months.

        Scinopharm Taiwan, Ltd. and the state-run Pharmaceutical Industry Technology and Development Center are among the institutions contracted to conduct preliminary testing of the drug, according to Lee Jih-heng, director of the Department of Health's (DOH) office on new flu controls. Officials expect that domestic production of enough generic Tamiflu doses to treat at least 2.3 million people will be possible by June.

        The NHRI's Vaccine Research and Development Center is ready to produce 100,000 doses of an antiviral vaccine by the summer, in preparation for increased demand from the public, according to Su Ih-jen, head of clinical research at NHRI. Su said that his department is working on next-generation vaccines against a possible mutated strain of the bird-flu virus.

        New technologies are still in the experimental stage, while at present, Taiwan only has enough Tamiflu to treat about 1 percent of its population, according to Center for Disease Control Director Kuo Hsu-sung. In light of the increased risk of a flu pandemic, the government in Taiwan plans to build a vaccine factory, Kuo said. Tenders were accepted as part of a US$180 million project proposed by the Cabinet in 2004.

        In an effort to get more foreign manufacturers to set up vaccine plants in Taiwan, the government offered incentives including lower taxes, special production agreements and a guaranteed minimum purchase of vaccines produced by participating factories. A build-operate-transfer pilot project run by the NHRI is expected to lead to an operational vaccine plant within five years, according to Deputy Health Minister Chen Tzay-jinn.

        Up to 40,000 preliminary doses of generic Tamiflu are expected to be manufactured for use on an emergency basis before the end of the month, according to the NHRI, whose immediate goal is to have Taiwan's antiviral drug stockpiled by April. NHRI representatives involved in the licensing negotiations with the Tamiflu patent holder, Roche Holdings AG, expect to reach a satisfactory conclusion in this regard as early as this month, according to DOH Secretary General Lai Jing-shiang.

        The legal options for circumventing the licensing process are being studied by law firms hired by the DOH, as well as the government's Intellectual Property Office (IPO), in the event of an outbreak in the immediate region, according to Health Minister Hou Sheng-mou. Under ROC patent law, the IPO would permit manufacturing for limited, non-commercial use in case of a national emergency, regardless of a lack of consent from the patent holder.

        Taiwanese scientists have been in a race against time, and against their counterparts abroad, to develop an antiviral solution to a hypothetical mutated strain of the regular H5N1 bird-flu virus now spreading throughout Asia. Health experts agree that should such a mutation occur allowing the bird flu to be transmitted from human to human, a major pandemic of global proportions would result.

        As of Nov. 14, 126 people in Southeast Asia have been infected, with 64 confirmed deaths from the H5N1 bird-flu virus, according to a World Health Organization report. In association with the rising number of confirmed human cases of avian influenza, tens of millions of birds have been culled in Asian countries to prevent the spread of the virus.