[Ip-health] News: Biolyse develops generic version of Tamiflu (Globe & Mail, 15 Feb 2006)

[Richard Elliott]

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[One clarification about the story below:  Apotex is seeking approval to
export an HIV/AIDS drug to developing countries but the application has not
yet been approved.  Readers should not be left with the impression that the
application has been refused.  In fact, the triple-combination drug was
already added to the list of drugs that are eligible for compulsory
licensing for export, but the other steps in the process set out in the
legislation are still in progress as far as we know.]





The Globe and Mail (Report on Business), February 15, 2006, p. B4

http://www.theglobeandmail.com/servlet/story/LAC.20060215.RBIOLYSE15/TPStor=
y
/?query=3D



BIOTECHNOLOGY


Biolyse develops generic version of Tamiflu


Will seek Ottawa's approval for export


LEONARD ZEHR

BIOTECHNOLOGY REPORTER

Generic drug maker Biolyse Pharma Corp. of St. Catharines, Ont., says it ha=
s
developed a generic formulation of Tamiflu and intends to seek government
approval to export the medicine to developing countries for stockpiling
against a possible pandemic outbreak of bird flu.

In a letter to the federal ministers of Health and Industry, Tony Clement
and Maxime Bernier, respectively, the company requested that its generic
formulation be added to a list of drugs eligible for export. It's understoo=
d
that generic drug maker Apotex Inc. of Toronto is seeking approval to expor=
t
an HIV/AIDS drug to developing countries but the application has not been
approved.

Under the 2005 Jean Chr=E9tien Pledge to Africa Act, amendments to the Pate=
nt
Act give Ottawa authority to grant compulsory licenses of patented drugs fo=
r
export to eligible countries in need of lower-cost medicines to address
public health problems.

Swiss-based F. Hoffmann-La Roche Ltd. holds the patents for the antiviral,
which treats seasonal influenza and could be used as a first line of defenc=
e
against pandemic bird flu. The multinational drug maker has an annual
capacity to make 300 million treatments of Tamiflu, consisting of 10
capsules taken twice daily for five days. However, it has been unable to
meet current demand for the drug from governments around the world.

Biolyse specializes in extracting chemicals from plants and biomaterials,
and now makes a generic version of the cancer drug paclitaxel from yew
trees. In December, it unveiled plans to manufacture shikimic acid, the mai=
n
ingredient used to make Tamiflu, from the needles of discarded Christmas
trees.

Most shikimic acid is now extracted from star anise, the fruit of a
slow-growing evergreen in China, which is harvested for only several months
each year. That's why Roche's production of Tamiflu takes about 12 months
and there isn't enough of the drug to go around for government stockpiling.

John Fulton, executive vice-president of Biolyse, said the company is
gearing up to make 50 kilograms a day of finished product or about 666,000
pills daily. It has been working on a generic version of Tamiflu for the
past two years and has developed a process to shorten the manufacturing
process to five weeks. No drug has yet been manufactured for stockpiling
because of Roche's patents.

He said Biolyse hopes its request can be added to the government list of
drugs eligible for export in the next few weeks. That would be followed by
studies to show that its generic formulation is bioequivalent to Roche's
brand-name product.

Noting that the Chr=E9tien Africa Act received unanimous support of all
parties in Parliament, he said the "legislation was intended to fast-track
these applications, so we hope we could clear this in a couple of months,
instead of a couple of years."

_____________________________________________



Richard Elliott

Deputy Director -- Directeur adjoint

Canadian HIV/AIDS Legal Network -- R=E9seau juridique canadien VIH/sida

1240 Bay Street, Suite 600

Toronto, Ontario, Canada M5R 2A7

T +1 (416) 595 1666 ext. 229

F +1 (416) 595 0094

www.aidslaw.ca





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