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[Richard Elliott]

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http://www.bloomberg.com/apps/news?pid=20601082
<http://www.bloomberg.com/apps/news?pid=20601082&sid=a3iAW8wuUu84&refer=cana
da> &sid=a3iAW8wuUu84&refer=canada



Canada to Let Biolyse Make Generic Version of Roche's Tamiflu

By Alexandre Deslongchamps

Sept. 27 (Bloomberg) -- Biolyse Pharma Corp., a closely held Canadian firm,
may soon become the first company to use a World Trade Organization treaty
to make a low-cost generic copy of Roche Holding AG's Tamiflu and help
developing countries fight a potential avian-flu pandemic.

The Canadian government on Sept. 21 added the drug, also known as
oseltamivir, to a list of patented medicines that can be produced and
exported to developing countries even as the patent remains active, a
process called compulsory licensing, Doug Clark, Industry Canada's director
of patent policy, said in an interview today. The list, which was
established in compliance with the 2003 WTO treaty and contains 58 drugs,
hasn't yet been used.

``We still have a lot of work to do, but, as of today, we can turn the
burners up,'' John Fulton, executive vice president with Biolyse, said in an
interview today. Biolyse is planning on producing 500,000 to 1,000,000 doses
a day once its facility is fully operational, he said.

Demand for drugs such as Tamiflu has surged since last October, when U.S.
scientists reported finding similarities between the H5N1 avian influenza
strain in Asia, which has killed at least 146 people since 2003, and the
Spanish flu that killed as many as 50 million in 1918 and 1919.

The World Health Organization said in May that Tamiflu is the most effective
treatment to the avian flu.

``Now that the product has been registered, there's nothing in the law to
stop them from proceeding with their clinical trials and then their license
requests,'' Industry's Clark said.

Developing World

After showing the country's health department its drug is biologically
equivalent to Tamiflu and getting orders from developing countries, Biolyse
will be granted a compulsory license, allowing it to export the drug under
strict price and profit restrictions, Fulton said. The earliest Biolyse
would start shipping its pills is in six months, he said.

Roche said in an August statement there was no need for Canada to add
Tamiflu to the list, because it had already granted licenses to generic-drug
makers that would be able to meet demand. Leigh Funston, Roche's national
manager for product and corporate communications, declined to comment
because she wasn't aware of the government's decision.

St. Catharines, Ontario-based Biolyse said it has found a way to produce the
drug from tree needles and started in January to extract shikimic acid, the
drug's main ingredient, from discarded Christmas trees.

Biolyse, founded in 1980, also makes the cancer drug paclitaxel. In May
2005, the company won a Supreme Court patent- infringement case against
Bristol-Myers Squibb Co., which sued Biolyse on the grounds that its drug
was a copy of Bristol's Taxol.

Biolyse extracts paclitaxel from a yew bush that is common in Canada,
instead of the rare Pacific yew bushes where the chemical was first
discovered.

To contact the reporter on this story: Alexandre Deslongchamps in Ottawa at
adeslongcham@bloomberg.net



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