Bolivia and Biolyse sign landmark agreement for export of COVID-19 vaccines

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Biolyse Pharma has reached an agreement with a South American country that could change the way critical and affordable drugs are manufactured for countries in need.

ST.CATHARINES, ON, May 12, 2021 /CNW/ - On May 11, 2021, Biolyse, an Ontario-based manufacturer of sterile injectable medicines, announced an agreement with Bolivia to produce and export COVID-19 vaccines, should Biolyse be allowed to make and export a COVID-19 vaccine, by way of a compulsory or voluntary license or intellectual property waiver.

Should the deal be formally concluded, it would help resolve deep inequities in vaccine distribution to countries lacking the capacity for a comprehensive rollout of patent protected vaccines in a public health crisis.

Rogelio Mayta, the Bolivian Minister of Foreign Affairs, announced the deal during the press conference held in La Paz. Brigitte Kiecken, President of Biolyse and Antony Taubman Director, Intellectual Property Division of the World Trade Organization joined the announcement online.

The initiative will also bolster the Canadian pharmaceutical production sector, while putting skin in the game to Canada's global commitment in vaccinating populations with limited access.

Biolyse has the potential to produce up to 50-million doses a year of an already-approved vaccine. Earlier this year the company started an effort to license the patents under the Canadian Access to Medicines Regime (CAMR), which allows export for humanitarian purposes.

CAMR is the Canadian legislation implementing article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which is an agreement between members of the World Trade Organization.

This Canadian measure has only been used once before, in 2007 by Apotex, to manufacture HIV medicines for export to Rwanda in Africa.

Earlier this year, Biolyse contacted Johnson & Johnson (J&J) for a license transfer request to produce the Ad26.COV2.S vaccine, but the company refused.

With J&J unwilling, Biolyse can use CAMR for authorization from the Canadian government through the Canadian Commissioner of Patents to make and export the vaccine, with a royalty fee paid to Johnson & Johnson.

In the meantime, Biolyse is continuing to convert and scale its biosimilars production facility to accommodate this bolstered COVID-19 vaccine production for Bolivia, and potentially other nations in need.

About Biolyse Pharma:

Biolyse Pharma is a research-driven, fully integrated pharmaceutical company headquartered in St. Catharines (Niagara), Ontario.

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SOURCE Biolyse Pharma


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