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
"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.
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.