CAMBRIDGE, Mass., Dec. 8 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to VX-950, an
investigational oral hepatitis C virus (HCV) protease inhibitor for the
treatment of HCV infection. The FDA granted Fast Track designation to VX-950
for the following reasons:
* Chronic hepatitis C virus infection is a serious and life-threatening
disease.
* VX-950 has the potential to shorten the duration of therapy compared to
the standard of care, which may result in improved sustained virologic
response rates and a more favorable adverse event profile.
Vertex is currently conducting a clinical development program to assess
whether VX-950 will address these unmet medical needs in HCV therapy.
Under the FDA Modernization Act of 1997, Fast Track designation indicates
that the FDA will facilitate the development and may expedite the review of a
drug if it is intended for the treatment of a serious or life-threatening
condition and demonstrates the potential to address an unmet medical need for
such a condition.
VX-950 Clinical Status
Earlier in 2005, Vertex concluded a 14-day, Phase Ib study of VX-950 that
showed a rapid and dramatic reduction in HCV RNA in HCV patients when VX-950
was administered as a single agent. Overall in the Phase Ib study, adverse
events observed in patients receiving VX-950 that were considered possibly
related to the drug were mild, and generally similar in frequency to events in
the placebo group. The most common adverse events reported in both placebo
and VX-950 patients were headache, frequent urination and gastrointestinal
symptoms. Based on these encouraging Phase Ib clinical results, Vertex
recently initiated two additional clinical studies with VX-950. In October
2005, Vertex initiated in Europe a 20-patient Phase Ib study of VX-950 dosed
in combination with pegylated interferon. In December 2005, Vertex initiated
in the United States the first Phase II study of VX-950, which will evaluate
the safety, tolerability and pharmacodynamics of VX-950 when dosed with
pegylated interferon and ribavirin. Vertex expects to obtain results from
both these Phase Ib and Phase II studies of VX-950 in early 2006. Vertex also
expects to initiate multiple additional Phase II studies in the United States
in 2006, including a three-month study in more than 200 treatment-naive
patients.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is
found in the blood of people with the disease. HCV, a serious public health
concern affecting 3.4 million individuals in the United States, is spread
through direct contact with the blood of infected people. Though many people
with hepatitis C may not experience symptoms, others may have symptoms such as
jaundice, abdominal pain, fatigue and fever. Hepatitis C significantly
increases a person's risk for developing long-term infection, chronic liver
disease, cirrhosis or death.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes
the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) VX-950 may shorten the duration of HCV therapy compared to
the standard of care; (ii) VX-950 may improve sustained virologic response
rates in HCV patients; (iii) VX-950 may have a more favorable side effect
profile than the current standard of care therapy; (iv) VX-950 will address
unmet medical needs in HCV therapy; (v) Vertex will advance VX-950 in clinical
development; and (vi) Vertex will initiate multiple Phase II clinical studies
of VX-950 in 2006, including a three-month study in more than 200 treatment-
naive patients. While management makes its best efforts to be accurate in
making forward-looking statements, such statements are subject to risks and
uncertainties that could cause Vertex's actual results to vary materially.
These risks and uncertainties include, among other things, the risks that
clinical trials for VX-950 may not proceed as planned due to technical,
scientific, or patient enrollment issues, or negotiations with regulatory
authorities over trial design or other matters, that the scale and scope of
future clinical and nonclinical studies may change and will be determined in
significant part by data collected in ongoing and future trials, that further
clinical studies of VX-950 may not reflect the results obtained in early
clinical and nonclinical studies, that ongoing nonclinical studies, including
toxicology studies, will yield currently unanticipated negative outcomes, that
results from the Company's clinical trials commenced during 2006 will be
insufficient to support a Phase III program without additional trials and
consequent delay in the timetable for potential approval, and other risks
listed under Risk Factors in Vertex's Form 10-K filed with the Securities and
Exchange Commission on March 16, 2005.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne H. Brum, VP, Corporate Communications and Financial Planning,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lynne H. Brum, VP, Corporate Communications
and Financial Planning, +1-617-444-6614, or Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, or Lora
Pike, Manager, Investor Relations, +1-617-444-6755, or Zachry
Barber, Specialist, Media Relations, +1-617-444-6470, all of
Vertex
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