[Ip-health] Biolyse succeeds in getting Canadian government to list generic Tamiflu (oseltamivir) for waiver of WTO/Nafta rules on exports of medicines

[James Love]

This is the first hurdle that Biolyse has overcome in exporting
generic oseltamivir to developing countries.  The next is to obtain a
compulsory license for export from the Canadian government.  Jamie

http://www.canada.com/topics/bodyandhealth/story.html?id=61ff306e-
c50f-48d5-b85f-f15896936285&k=98506

Ontario company wins key approval for anti-flu drug
Would export generic version of Tamiflu to developing nations
Tom Blackwell
National Post

Thursday, July 06, 2006

CREDIT: Peter Redman/National Post
Biolyse Pharma would use Christmas tree needles to produce a generic
version of Tamiflu.

A Canadian drug company eager to make a generic version of Tamiflu
using needles from used Christmas trees -- and export the anti-flu
drug to developing countries -- has won a key approval from the
federal government.

A proposed new regulation would place the medicine on a list of drugs
that can be copied by generic manufacturers and sold to impoverished
nations before their patent expires.

Biolyse Pharma, the Ontario company that wants to make the Christmas-
tree product, called the government move exciting. It says it has
been flooded with offers from companies as far afield as Papua New
Guinea anxious to unload Christmas trees and other evergreens.

Biolyse extracts shikimic acid, the key ingredient in Tamiflu, from
the needles, an alternative source to the star anise plant available
only in China in limited quantities.

"We've been working on this for two years," said John Fulton, vice-
president of the firm based in St. Catharines, Ont. "We've invested
hundreds of thousands of dollars into research and development. We're
very happy."

But Hoffman-La Roche, which has the rights to market Tamiflu, said
yesterday there is no reason to let the Canadian firm duplicate its
drug, known scientifically as oseltamivir, since it is already
exceeding demand.

"We don't feel a need will present itself in the developing world to
access Canadian generic products," said Ilona Torontali of Roche
Canada. "We're quite confident we can meet demand."

Experts consider Tamiflu the leading weapon against a flu pandemic,
if one emerges, and there has been a worldwide rush to build
stockpiles of it.

As pandemic fears grew and orders for the anti-viral took off, the
prices charged by Chinese suppliers for star anise jumped from $50 a
kilogram to as much as $1,000, Mr. Fulton said.

But shikimic acid exists in many other plants, and scientists at
Biolyse found they could extract it relatively cheaply from evergreen
needles.

Just the announcement of that discovery has had an effect on the cost
of raw ingredients, it would seem. Chinese suppliers are now offering
star anise for about $150 a kilo, Mr. Fulton said. At that price, it
is actually cheaper to buy from China than to use the evergreen
extraction method, though prices are likely to rise again, he said.

The proposed regulation, which has yet to get final Cabinet approval,
would put oseltamivir under so-called schedule one of the Patent Act.

Generic versions of the 40 or so drugs on that list can theoretically
be made before the patent expires, if a developing country makes a
request for supply. It is part of a two-year-old law originally
designed to get expensive AIDS drugs to African countries that could
not afford brand-name prices.

Before Biolyse takes advantage of the new development, though, it
would have to get its generic version approved by Health Canada, and
a developing country would have to ask for some. Then the government
would issue a "compulsory licence" allowing the export, said Brigitte
Zirger, a policy expert at Health Canada.

Meanwhile, Hoffman-La Roche has already increased 10-fold its
capacity to produce Tamiflu, partly through sub-licences it has
granted companies in China, India and South Africa, said Ms.
Torontali. It can now make four billion capsules a year and it
charges lower prices in needy countries, Ms. Zirger said.

Biolyse has created its generic osletamivir pills in the laboratory
but still needs new-drug approval from Health Canada.

If a pandemic does hit, it could be the only North American-based
producer of the drug and it would likely be able to supply Canadians,
as well as its developing-world customers, Mr. Fulton said.

"We're the backup. We're the fire extinguisher," he said. "This place
will have to be fortified."

tblackwell@nationalpost.com
National Post 2006


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James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton