CAMBRIDGE, Mass., Oct. 4 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) announced today that it will concentrate its
development investment in 2006 on Phase II clinical development of its drug
candidates VX-950 for hepatitis C virus (HCV) infection and VX-702 for
rheumatoid arthritis (RA). In addition, the Company expects to bring forward
into clinical development in 2006 an investigational drug candidate for cystic
fibrosis (CF). Vertex's updated focus on accelerating the clinical
development of these three proprietary product candidates is based on an
analysis of commercial opportunity and available clinical data across all of
the Company's portfolio of programs. The Company expects to minimize its own
future development investment in both merimepodib (MMPD), an oral compound
designed to enhance the antiviral efficacy of interferon-based combination
therapy for HCV, and VX-765, an interleukin-1 beta converting enzyme (ICE)
inhibitor for the treatment of psoriasis. In addition to three areas where
Vertex will focus its development investment, Vertex will continue to
collaborate with other companies to develop small molecule drugs for cancer
and HIV.
"Focusing our development portfolio in 2006 on VX-950 and VX-702 supports
our commitment to the rapid clinical advancement of these compounds, which
have the potential to be exciting new treatment options for HCV and
inflammation," said Joshua Boger, Ph.D, Chairman, President and Chief
Executive Officer of Vertex Pharmaceuticals. "We believe that based on a
rigorous analysis of available clinical data across all of our programs, and
an appreciation of the commercial opportunity in our areas of concentration,
the decision to focus our portfolio will drive clinical and commercial value
for Vertex and its shareholders in the coming years.
"In addition to the compounds that we seek to develop independently, we
are working with collaborators to develop innovative therapies in the areas of
cancer and HIV, and this will continue to be an important component of our
business model going forward," added Dr. Boger.
Vertex's Clinical Pipeline
VX-950:
VX-950 is an investigational oral HCV protease inhibitor and is one
of the most advanced in a new class of medicines for the treatment
of chronic HCV infection. In a 14-day, Phase 1b study concluded
earlier in 2005, VX-950, administered as a single agent, produced a
rapid and dramatic reduction in HCV-RNA in HCV patients.
Vertex is on track to expand its clinical program in the fourth
quarter of 2005 and to conduct a variety of key clinical studies
with VX-950 in 2006, including a one-month study in combination
with pegylated interferon, and a three-month study in combination
with pegylated interferon that will be designed to evaluate
sustained viral responses in HCV-infected patients.
VX-702:
VX-702 is an investigational oral p38 MAP kinase inhibitor designed
to inhibit inflammatory cytokine production. Inhibition of p38 MAP
kinase represents a promising mechanism for the treatment of RA and
a wide variety of inflammatory diseases.
Vertex is actively enrolling patients in a three-month, 300-
patient, Phase II clinical study in RA in more than 40 centers in
Europe. Vertex expects to complete enrollment in the RA trial by
year-end 2005 and to report top-line results from the Phase II
study in mid-2006.
Cystic Fibrosis:
Vertex has advanced into late-stage discovery two new classes of
compounds that may partially restore the function of the defective
cell membrane protein that is responsible for the development of
CF. Vertex has identified a series of compounds that could act as
"potentiators" -- compounds that directly increase the gating
ability of the defective ion channel -- and "correctors" --
compounds that enhance the number of Cystic Fibrosis Transmembrane
Regulator (CFTR) channels at the cell surface. Vertex expects to
advance a compound for CF into clinical development in 2006. To
date, significant funding for Vertex's drug discovery efforts in CF
has been provided through its collaboration with Cystic Fibrosis
Foundation Therapeutics, Inc. (CFFT).
Merimepodib (MMPD):
Vertex is conducting two Phase II clinical studies with MMPD.
Vertex is continuing to conduct the ongoing METRO study, a triple
combination, Phase II trial that has enrolled 356 patients who were
non-responsive to a combination of pegylated interferon and
ribavirin, as well as a 28-day viral kinetic study of MMPD in
combination with ribavirin only. Vertex plans to complete the
METRO study in 2006 and is on track to complete the Phase II, 28-
day viral kinetic study in the fourth quarter of 2005. The Company
does not currently plan to conduct additional MMPD clinical studies
after these two ongoing clinical trials are completed.
VX-765:
VX-765 is an oral cytokine inhibitor for inflammation. Vertex has
completed dosing in a four-week, Phase IIa safety and
pharmacokinetic study with VX-765 in 68 patients with psoriasis.
Vertex Compounds in Development with Collaborators
VX-385 (GSK):
VX-385, an HIV protease inhibitor (PI) with demonstrated in vitro
activity against viral isolates resistant to multiple currently-
marketed PIs, is under development as part of Vertex's
collaboration with GlaxoSmithKline (GSK). GSK initiated a Phase
IIb clinical study of VX-385 during the third quarter of 2005.
VX-680 (Merck & Co.):
VX-680, a small molecule inhibitor of Aurora kinases, is being
developed as part of a worldwide collaboration with Merck for
oncology indications. Currently, VX-680 is being tested in three
clinical studies in the U.S.
VX-944 (Avalon Pharmaceuticals):
VX-944, a novel inosine monophosphate dehydrogenase (IMPDH)
inhibitor, is under development by Avalon Pharmaceuticals for
oncology indications under a worldwide license from Vertex.
Avalon's Investigational New Drug (IND) application is now open for
VX-944. Avalon, which recently closed its initial public offering,
plans to initiate a clinical trial of VX-944 in a hematological
cancer indication in the fourth quarter of 2005.
Continued Commitment to Drug Discovery
Vertex maintains a strong commitment to research and will continue to
focus on early drug discovery efforts targeting cancer, pain, inflammation and
infectious disease. Vertex continues to collaborate with Novartis to discover
and develop novel kinase inhibitors for the treatment of cancer and other
diseases.
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. In collaboration with
GlaxoSmithKline, Vertex co-promotes the HIV protease inhibitor, Lexiva.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that Vertex expects (i) to concentrate its 2006 development
investment on VX-950 and VX-702 and to minimize future development investment
in merimepodib and VX-765; (ii) to bring forward into clinical development in
2006 an investigational drug candidate for cystic fibrosis; (iii) that
Vertex's decision to focus its portfolio will drive clinical and commercial
value for the Company and its shareholders; (iv) that it will expand its
clinical program for VX-950 in the fourth quarter of 2005 and conduct a
variety of key clinical studies in 2006, including one-month and three-month
studies of VX-950 in combination with pegylated interferon; (v) to complete
enrollment by year-end 2005 and report top-line results in mid-2006 of its
Phase II study of VX-702 for rheumatoid arthritis; and (vi) that Avalon
Pharmaceuticals will begin a clinical trial of VX-944 in a cancer indication
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 clinical trials may not proceed as planned due to technical,
scientific, supply or patient enrollment issues, that the Company will change
its focus and priority as new information comes to light and we gain
additional insight into ongoing programs and potential new programs, that
clinical trials will not reflect the results obtained in nonclinical testing
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 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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