Life Saving AIDS Drug for Africa Gets Final Clearance



    TORONTO, Sept. 21 /CNW/ - The Federal Commissioner of Patents issued
today a compulsory licence for ApoTriavir under Canada's Access to Medicines
Regime Program (CAMR) allowing Apotex to proceed with manufacturing of the
product. This drug, a triple combination AIDS therapy, was the first product
to be approved by Health Canada under the provisions of the CAMR. ApoTriavir
was approved by Health Canada in August 2006 and is pre-qualified by the World
Health Organization.
    The CAMR was designed to help developing countries that have little or no
pharmaceutical manufacturing capacity in their fight against HIV/AIDS,
tuberculosis, malaria and other diseases.
    Rwanda was the first African country to request ApoTriavir under this
established process and the licence today opens the way for us to provide
quality medicine at an affordable price to the Government of Rwanda. The delay
between approval by Health Canada and issuance of the compulsory license
highlights the problems with the process as it exists. It is unnecessarily
complex and does not adequately represent the interests of those who require
treatment. As it now stands the process is voluntary and controlled by the
multinational pharmaceutical companies who hold patents for drugs like
Apo-Triavir. In this case, Glaxo Smith Kline (GSK), Shire and Boehringer
Ingelheim were the three patent holders and each put forward numerous
conditions for issuing a voluntary license.
    In the end, GSK and Shire did not oppose the application, but chose not
to grant a voluntary licence, requiring Apotex to navigate the complexities of
the CAMR. Boehringer Ingelheim was also not prepared to freely grant a
licence.
    This process of obtaining a license to produce a product has to be
restarted every time a new country makes a request. There is no assurance that
the patent holders will not attempt to once again delay the process and the
supply of these vital medicines to developing countries in the future. "We are
doing this on a not-for-profit basis and hope that this life-saving drug gets
to the thousands of patients in Africa dying every month; the Canadian Federal
Government must change the process to get quality affordable medicines to
those who have no access", stated Jack Kay, President and COO of Apotex.

    Apotex is Canada's largest pharmaceutical company with over 300 medicines
exported to 115 countries and its planned R&D expenditures over the next 10
years are $2 Billion.





For further information:

For further information: Elie Betito, Director, Public & Government
Affairs, Apotex Inc., Tel: (416) 749-9300, Cell: (416) 558-5491, e-mail:
ebetito@apotex.com


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