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Press Release From Vertex
  Vertex Pharmaceuticals Announces Submission of NDA/MAA Filings in U.S. and Europe for GW433908 (new formulation of Agenerase [amprenavir]) for Treatment of HIV Infection
Cambridge, MA, December 20, 2002 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of GW433908 (also known as 908 or VX-175), an investigational HIV protease inhibitor in development for the treatment of HIV infection. GSK has simultaneously submitted a Marketing Authorization Application (MAA) for regulatory approval of 908 in the European Union. The 908 compound was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals.
The submissions for registration include data from more than 1,100 treatment-naive and treatment-experienced patients who have participated in Phase III trials to evaluate the safety and efficacy of 908 in comparison with two widely used HIV protease inhibitors. In clinical trials, 908 was dosed as two tablets in both once-daily and twice-daily regimens.
"The regulatory submissions announced today represent a significant accomplishment for GSK and Vertex in 2002," said Joshua Boger, Ph.D., Chairman and CEO of Vertex. "Based on the data we have gathered in pivotal studies, we believe that 908 has the potential to be an important new option for the treatment of HIV, and one that is well-suited to the needs of today's HIV patients."
Once approved, GSK will market 908 and Vertex will co-promote in the U.S. and key markets in Europe. In connection with the regulatory filings announced today, Vertex earned a milestone payment from GlaxoSmithKline that will be realized in the fourth quarter of 2002.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company. Vertex seeks to discover, develop, and commercialize major pharmaceutical products independently and with partners. Chemogenomics, Vertex's proprietary, systematic, genomics-based platform, is designed to accelerate the discovery of new drugs and to expand intellectual property coverage of drug candidate compounds and classes of related compounds. This approach, which targets gene families, has formed the basis for several commercial collaborations under which Vertex retains rights to downstream revenue. Vertex's first approved product is Agenerase (R) (amprenavir), a protease inhibitor, which Vertex co-promotes with GlaxoSmithKline. Vertex has more than 12 drug candidates in clinical and preclinical development to treat viral diseases, inflammation, cancer, autoimmune diseases, neurological disorders and genetic disorders.
This press release may contain forward-looking statements, including statements that 908 has the potential to be an important new option for HIV patients, and that 908 may be approved and launched in the United States and the European Union. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties, including the risk that 908 may not receive marketing approval in the United States and Europe, and that it may not prove to be successful as an important therapy for HIV patients, that could cause Vertex's actual results to vary materially. These risks and uncertainties include, in addition, those listed under Risk Factors in Vertex's Form 10-K filed with the Securities and Exchange Commission on April 1, 2002.
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