AEGiS-PRn: 3TC(R) Approved in Canada for Use in Combination With AZT First Initial Therapy for HIV Since 1990 PRNewswireImportant note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
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3TC(R) Approved in Canada for Use in Combination With AZT First Initial Therapy for HIV Since 1990

PR Newswire - December 12,1995


MONTREAL and TORONTO, Dec. 12 /PRNewswire/ -- Glaxo Wellcome Inc. and BioChem Pharma Inc. announced today that the Drugs Directorate of the Health Protection Branch (HPB) of Health Canada has approved 3TC(R) (lamivudine) Tablets and Oral Solution under its priority review process for use in combination with Retrovir(R) (zidovudine, commonly known as AZT) for the treatment of HIV infection and AIDS.

Today's announcement marks the first time a combination therapy has been approved for initial treatment of HIV infection. "The HPB's action clears the way for more widespread availability of this combination which, while currently being studied for its impact on survival and delay in disease progression, has demonstrated the most pronounced and prolonged effect on clinical markers of HIV than any currently available therapy," said Dr. Emil Toma, Infectious Disease Specialist at the Hotel-Dieu-de Montreal. "The HPB's approval also supports the scientific opinion that, in the future, combination therapies will be the optimal treatments for improving the quality of life and extending the life of people living with HIV and AIDS."

3TC(R) is a new generation orally active nucleoside analogue belonging to a class of compounds that interferes with reverse transcriptase, an enzyme used by HIV to replicate. Pivotal clinical studies conducted by independent investigators in both Europe and North America and presented previously concluded that 3TC(R) used in combination with AZT has sustained effectiveness on improving immunity and lowering the amount of HIV in the blood, as indicated by CD4 cell counts and viral load. This combination was also shown to be well-tolerated.

3TC(R) was discovered by BioChem Pharma in Montreal, Quebec, and was developed by Glaxo Wellcome. "We are proud that 3TC(R) was discovered by our Canadian scientists and that, in partnership with Glaxo Wellcome, we are making this contribution to the treatment of HIV disease. The partnership between BioChem and Glaxo Wellcome has made possible the effective timely development of 3TC(R). BioChem remains committed to HIV research through extensive international programs aimed at the discovery of new treatments for HIV disease and its complications," said Dr. Francesco Bellini, President and CEO of BioChem Pharma Inc.

Up until today's announcement, AZT was the only therapy approved in Canada for the initial treatment of HIV.

"Glaxo Wellcome and BioChem through partnership worked together to effectively develop 3TC(R) and make it available in an accelerated manner, thus demonstrating successful inter-company collaboration. People living with HIV and their physicians across Canada played an active role in the clinical evaluation of 3TC(R)," said Paul Lucas, President and CEO of Glaxo Wellcome Inc.

Glaxo Wellcome and BioChem are committed to on-going research in the treatment of HIV with a view to improving the quality of life of people living with HIV/AIDS. Through the open-label program, close to 2,800 people living with HIV/AIDS were able to access 3TC(R) in Canada prior to its approval.

Canada is the second country to approve 3TC(R) following market clearance in the U.S. announced on November 20, 1995.

Under the terms of the BioChem-Glaxo Wellcome license agreement, BioChem will receive a royalty based on sales and Glaxo Wellcome has the right to develop, manufacture and sell 3TC(R) worldwide. An equally-owned joint venture will commercialize 3TC(R) in Canada.

BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the detection, prevention and treatment of human diseases. The company's shares are traded on the Montreal and Toronto stock exchange (BCH) and on NASDAQ (BCHXF).

Glaxo Wellcome Inc., with more than 1100 employees across the country, is part of the world's largest research-based pharmaceutical company Glaxo Wellcome plc. The company is committed to being an international leader in research, development, production and marketing of high-quality and innovative medicines in the therapeutic areas of respiratory, gastro-intestinal, migraine, infectious disease, oncology, dermatology and central nervous system to improve quality of life and disease outcomes.

Note: A Video News Release will be transmitted via satellite downlink on Tuesday, December 12, 1995 at 1:30 - 2:00 p.m.

3TC(R) Registered Trade Mark of Glaxo Group Ltd. Glaxo Wellcome BioChem Inc. Licensed user.

For further information: Tim Turnbull, Manager, Corporate Communications, Glaxo Wellcome Inc., (905) 819-3022;

Christine Lennon, Director, Investor and Corporate Communications, BioChem Pharma Inc., (514) 978-7771;

Marie-Christine Beauchemin, Manager, Public Relations and Communications, Glaxo Wellcome Inc., (514) 738-8886 ext. 351;

John Crean, NATIONAL PharmaCom - Toronto, (416) 586-0180;

Michele Roy, NATIONAL PharmaCom - Montreal, (514) 843-7171;

Diane Kossman, Maureen Payne & Associates - Calgary, (403) 266-5880;

Martin Livingston, NATIONAL PharmaCom - Vancouver, (604) 684-6655;

Pearleen Mofford, Corporate Communications Limited - Halifax, (902) 421-1777/ 09:16 ET

Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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