Breaking News About How To Mass Produce Tamiflu Drug To Help Combat Bird Flu
September 8th, 2008

Since antiviral medications could be effective in treatment of the bird flu, or avian influenza, the U.S. government has purchased 26 million antiviral treatment courses and expects to have on hand a total of 81 million treatment courses by the end of 2008. HHS is stockpiling enough antiviral medications to treat 25% of the U.S. population, which is based on historical data from past pandemics showing that roughly 25% of the population would get sick in a pandemic. These people would benefit from antiviral treatment if started early in the course of the illness.

The antiviral drug known by the brand name, Tamiflu, is thought to be an effective treatment for humans infected with the H5N1 bird flu if started in the early part of the illness. The demand for this drug in the event of a pandemic will be enormous.

Scientists from the ROC National Heath Research Institutes (NHRI) have claimed to have succeeded in producing a generic version of tamiflu. On October 21, Taiwanese manufacturers of generic drugs from several different companies began trial production of the medication under auspices of the NHRI to prepare for mass production for commercial purposes. NHRI researchers were optimistic that the island’s generic drug makers would be ready to mass-produce stockpiles of Tamiflu within five months, once a license to manufacture is obtained and a supply of raw materials were collected.

New technologies are still in the experimental stage, and at the present time Taiwan only has enough Tamiflu for about 1% of the population. They are planning to build a vaccine factory in preparation for a flu pandemic. The patent-holder of the drug Tamiflu, Roche, has offered to allow others to produce the drug, which is known generically as oseltamivir phosphate. “We are prepared to discuss all available options, including granting sublicenses, with any government or private company who approaches us to manufacture Tamiflu or collaborate with us in its manufacturing,” William M. Burns, CEO of Roche Pharma, said in a statement.

A company called Cipla, located in India, plans to produce the drug and says that they don’t need Roche’s permission to do so. “I am not intending to sell the product where there are valid patents,” says Cipla Chairman Yusuf K. Hamied. He also points out that India has yet to grant Roche a patent on Tamiflu and will object if it is granted. Cipla plans to sell Tamiflu in India and 49 less developed countries where the company already sells AIDS treatments.

One major obstacle that supplies face is the difficulty in obtaining the key raw material, shikimic acid. It is extracted from star anise, in China where the major source of the material is located. Even if the materials are obtained, 10 daunting major steps are required to produce the drug, taking as long as 12 months. The process involves using potentially explosive sodium azide to introduce nitrogen into the molecule. Familiarity with this manufacturing process is the best way to increase output, says Roche.

Roche says that they are doing their best to increase Tamiflu’s production and says they can fill most orders within the year. They announced that the FDA has just granted it the right to open another capsule manufacturing plant in the U.S. and have extended their licensing offer to allow others to make the drug. All this after Roche has been accused of not doing enough to help the situation. To further complicate the development of public health strategies, resistance to Tamiflu has appeared in the avian flu virus isolated from a Vietnamese patient. This drug may not be the answer to the problem, but nonetheless will be in great demand and short supply in the event that a global avian flu pandemic occurs.

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