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OCTOBER 3, 2005

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New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track


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Mon Oct 03 08:00:33 2005 EST
MONTREAL, Oct 03, 2005 /PRNewswire-FirstCall via COMTEX/ --
New data show that patients
with genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an
investigational oral HCV protease inhibitor being developed by Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX), rapidly achieved substantial
reductions in alanine aminotransferase (ALT) levels after 14 days of
treatment. The findings were presented today by researchers at the 12th
International Symposium on Hepatitis C and Related Viruses (HCV 2005) in
Montreal, Canada. Vertex also provided an update on clinical development of
VX-950, which is one of the most advanced of a new class of medicines in
development for the treatment of chronic hepatitis C infection.
Data from a 14-day clinical study demonstrated that treatment with any one
of three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in
all dose groups. In the placebo group, a median 8 U/L increase was observed.
Prior to treatment with VX-950, serum ALT levels were elevated in
approximately 70 percent of patients in the study. In the VX-950 dose groups,
83 percent (15 of 18) of patients with elevated ALT levels at baseline (prior
to treatment) had achieved normalization of ALT levels at day 14, compared to
0 percent (0 of 6) in the placebo group. Elevated ALT levels are common in
HCV patients and are considered to be a marker of liver injury due to HCV
infection. Mean levels of serum neopterin also were observed to decrease with
VX-950 treatment in the study. Decreased neopterin levels may be a further
signal of a reduction in inflammation associated with HCV infection.(1)
A study of viral isolates from patients at baseline in a 14-day clinical
study, also presented at the conference, found heterogeneity among viral
sequences in the HCV protease domain. In vitro analysis indicated that all
baseline viral isolates were sensitive to VX-950.(2)
"To date, data from early clinical studies have suggested that VX-950 is
well-tolerated and can rapidly reduce HCV viral levels in patients over a
short treatment period," said John Alam, M.D., Senior Vice President of Drug
Evaluation and Approval at Vertex. "In addition, we now have evidence that
treatment with VX-950 appeared to lead to a dramatic decline in markers of
liver injury associated with viral infection."
Clinical Update
Vertex affirmed today that it remains on track to achieve key milestones
in its VX-950 clinical program in the fourth quarter of 2005, including
initiation of a 14-day Phase Ib combination study of VX-950 and pegylated
interferon in Europe and filing of an investigational new drug (IND)
application in the United States to support Phase II development of VX-950.
Vertex anticipates that it will initiate a 28-day, Phase II combination study
of VX-950 and pegylated interferon by year-end. Vertex expects to present
additional VX-950 clinical data at two more medical conferences in the fourth
quarter of 2005.
Clinical Need and Market Opportunity in HCV Infection
Chronic hepatitis C virus (HCV) infection is a serious public health
concern affecting approximately 2.7 million people in the United States. HCV
causes inflammation of the liver, which may lead to fibrosis and cirrhosis,
liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting
from chronic HCV infection is the leading reason for liver transplantation in
the U.S. Due to the asymptomatic nature of HCV infection, it often goes
undetected for up to 20 years following initial infection. Worldwide, the
disease afflicts as many as 170 million people. Each year, 8,000 to 10,000
people in the U.S. die from complications of HCV infection.
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(R), with GlaxoSmithKline.
This press release may contain forward-looking statements, including
statements that (i) VX-950 is well-tolerated, can dramatically reduce HCV
viral levels over short treatment periods, and can lead to a reduction in
liver injury associated with viral infection; (ii) Vertex is on track to
achieve milestones in its VX-950 clinical program in the fourth quarter of
2005, including the initiation of a Phase Ib clinical trial in Europe, the
filing of an IND in the U.S. and commencement of a Phase II clinical trial in
the U.S.; and (iii) Vertex expects to present additional VX-950 clinical data
at one or more medical conferences in the fourth quarter of 2005. 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 early clinical trial
results will not be duplicated in later, larger trials, that planned clinical
trials for VX-950 may not proceed as expected due to technical, scientific, or
patient enrollment issues, that the planned IND filing will be delayed due to
operational issues or the unavailability of required clinical data, or that,
when filed, the IND will not be allowed by the FDA to open without additional
studies or data which may not be readily available, and other risks listed
under Risk Factors in Vertex's form 10-K filed with the Securities and
Exchange Commission on March 16, 2005.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne Brum, Vice President, 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, Media Relations Specialist, (617) 444-6470
(1) H Gelderblom et al, "Decline in Serum Neopterin Concentration
Correlates with HCV RNA Decline During Administration of VX-950, a Hepatitis C
Virus Protease Inhibitor," 12th Annual International Symposium on Hepatitis C
and Related Viruses, Montreal Canada.
(2) T Kieffer et al, "Genetic Heterogeneity in the HCV NS3 Protease of
Untreated Genotype 1 Patients Has Little Effect on the Sensitivity to VX-950,"
12th Annual International Symposium on Hepatitis C and Related Viruses,
Montreal Canada.
SOURCE Vertex Pharmaceuticals Incorporated

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