Canada Adds Oseltamivir to Canadian Access to Medicines Regime

Biolyse Press Release
September 28, 2006

Biolyse Pharma Corporation announced today that the Governor General of Canada has approved and signed an order in council following Biolyse Pharma's request to amend Schedule 1 to the Patent Act to add "oseltamivir phosphate", in both capsule form as well as in powder for oral suspension, to the list of patented pharmaceutical products eligible to be exported under compulsory license of the Canada's Access to Medicines Regime (CAMR).

John R. Fulton, Executive Vice President of Biolyse Pharma, commented that "All Canadians should be proud of the work that all levels of government and non-government groups like Consumer Project on Technology, HIV/Aids Legal Network and Doctors Without Borders have done to make this a reality. Canada is the world's first country to adopt the World Trade Organisation's General Council 2003 decision and make real efforts to implement it. Rick Dykstra MP St.Catharines has been instrumental in making sure that the Biolyse request has been at the top of the federal government's "to do list". The Government of Canada is showing that it is not only committed to improving access to less expensive medicines urgently needed to treat HIV/AIDS and other diseases in developing countries, but also to global public health like the Bird Flu Pandemic".

Fulton further added: "We also would like to take this opportunity to express our concerns on the procedure to amend Schedule 1. The procedure designed in Article 21.03 (1) of the Patent Act requires a Governor in Council decision following the recommendation of both the Minister of Industry and the Minister of Health. During the process of drafting and passing the Jean Chr=E9tien Pledge to Africa Act, stakeholders were repeatedly assured that it would be a simple, rapid process for Governor in Council to add products to Schedule 1, but unfortunately it has not been the case. Biolyse Pharma formally requested the amendment in February 2006, more than 7 months have been needed to amend Schedule 1".

This announcement means that Biolyse can now fully industrialize their innovative process for making a generic version of Tamiflu, complete their application for regulatory approval and apply to Health Canada for a compulsory license. Under the JCPA Act over one hundred developing nations qualify for importation of Biolyse's low cost version of Tamiflu. Biolyse will be marketing their medicine at approximately 25% of the current world wide selling price.


John Fulton
EVP Biolyse Pharma Corporation

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