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Pharma company seeks foreign partner for flu drug clinical trials

By Kyle Sherer
May 17 - 23, 2010
Fameflu
Fameflu, produced by Fame Pharmaceuticals, uses a similar compound to Tamiflu, a medicine used to treat A(H1N1) infuenza. Pic: Christopher Davy

A YANGON-BASED pharmaceutical company that says it has developed an antiviral drug containing the same active ingredient as Tamiflu is seeking an international partner willing to test the medicine on human subjects infected with the A(H1N1) virus.

U Tin Maung Aye, director of Fame Pharmaceuticals, told The Myanmar Times that the company doesn’t have the facilities to trial the drug in Myanmar and Fame is in talks with a South Korean organisation about the possibility of conducting clinical trials there.
Previous discussions with a German company were unsuccessful, he said.

Fame Pharmaceuticals, which manufactures organic and traditional medicine, last year began producing Fameflu – a product which contains shikimic acid, the active ingredient in Tamiflu. As with Tamiflu, Fame Pharmaceuticals uses shikimic acid drawn from the Chinese star anise plant.

According to U Tin Maung Aye, the company manufactured 100,000 boxes of Fameflu last year. He said that the product is not manufactured every month, due to the relatively low level of demand in comparison to other Fame products, but he said that if demand were high enough the factory could produce up to 10,000 boxes of Fameflu a month.

Tamiflu is the trade name for the anti-viral drug oseltamivir, a flu treatment that is one of two drugs identified by the World Health Organisation as being effective in combating the A(H1N1) strain, commonly referred to as “swine flu”.

Fameflu is currently being sold in Myanmar for K1000 per box as a treatment for regular influenza, with no reference to A(H1N1) on the packaging.

U Tin Maung Aye said that the company would not market Fameflu as an A(H1N1) treatment until it could satisfy official regulations, which require clinical human tests.

The patent for Tamiflu is controlled by Swiss company Roche Holding AG. However, the company’s intellectual property rights to the drug’s compound only apply in countries where it has secured a patent.

U Tin Maung Aye said that because of differences between Fameflu and Tamiflu, there is no breach of patent rights. He said that in addition to shikimic acid, Fameflu contains other extracts from the star anise plant.

A product description in the Fame Pharmaceuticals catalogue, which is included inside Fameflu boxes, makes specific mention of both Roche and oseltamivir.

“Star anise fruit has been used in Traditional Chinese Medicine since thousands of years ago,” the description says. “Recently Roche, a Swiss Pharmaceutical Company, discovered the active compound inside the fruit called oseltamivir which is the only available medicine for treatment of influenza. FAME has also developed the extraction method to have anti-viral compounds for influenza and the product is known as ‘Fameflu’.”

The Myanmar Times emailed Roche to ascertain whether the company held a patent for Tamiflu in Myanmar but received no response. The Roche website lists Thailand, the Philippines and Indonesia as examples of countries where a Tamiflu patent is not held.

As fear over influenza pandemics rose and demand for the drug soared in 2005, Roche reached agreements with the governments of India, China, and Vietnam that gave them sub-licences to produce the drug.

That same year, the government of Thailand announced that it would also start producing oseltamivir.

And a patent does not necessarily rule out the possibility of a local company producing oseltamivir. In 2008, the Indian company Cipla won a court case allowing it to manufacture a generic version of oseltamivir, resulting in a cheaper anti-flu medication that WHO judges to be just as effective as Tamiflu.