-- Vertex earns $10 million milestone payment --
CAMBRIDGE, Mass., April 5 /PRNewswire-FirstCall/ -- Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation
of a Phase II clinical development program for VX-680, an investigational
drug candidate targeting Aurora kinase. In connection with the initiation
of Phase II development, Vertex earned a $10 million milestone payment in
March 2006 from Merck & Co., Inc. Vertex and Merck have a global
collaboration to develop and commercialize VX-680.
The initiation of Phase II development for VX-680 is based on the
enrollment of patients with advanced colorectal cancer in a Phase II
extension of a previous Phase I clinical study. In addition, Merck expects
to initiate a Phase II clinical study for VX-680 in patients with advanced
lung cancer this year.
"We continue to make progress in the development of VX-680 as marked by
the initiation of the Phase II clinical development program," said Stephen
H. Friend, M.D., Ph.D., Executive Vice President, Oncology at Merck
Research Laboratories. "This Phase II study represents a continuation of
our efforts to broadly assess the activity of VX-680 in a range of solid
tumors and hematologic cancers."
"VX-680's advancement to Phase II clinical development underscores the
rapid progress that we and Merck have made to characterize the activity of
this novel, potential cancer treatment," said Joshua Boger, Ph.D.,
Chairman, President and CEO of Vertex.
Phase II Study in Colorectal Cancer
The initiation of Phase II development for VX-680 is based on the
enrollment of patients with advanced colorectal cancer who may have
received up to three prior cancer treatments. The open-label,
non-randomized study will enroll approximately 20 patients and is being
conducted at major cancer treatment centers in the U.S.
Additional information on clinical trials for VX-680 is available at
the National Institutes of Health clinical trial database at
http://www.ClinicalTrials.gov (a service of the U.S. National Institutes of
Health developed by the National Library of Medicine).
AACR Presentation
On Tuesday, April 4, 2006 at the 97th Annual Meeting for the American
Association for Cancer Research (AACR) in Washington, DC, Vertex scientists
presented a poster titled "Structural Basis for Potent Inhibition of the
Aurora Kinases, Wild Type Abl Kinase and a T315I Multi-Drug Resistant
Mutant Form of ABL Kinase by VX-680." In vitro, VX-680 is a potent
inhibitor of wild type and drug resistant mutants of Abl kinase and Aurora
kinases. Studies performed by Vertex scientists provide a structural
interpretation for this potent inhibition and support the clinical
investigation of VX-680 in patients with treatment-resistant forms of
chronic myelogenous leukemia (CML). Merck is currently conducting a Phase I
study with VX-680 in patients with hematologic cancers, including CML
patients who have failed prior treatment.
VX-680 Clinical Studies
In addition to the Phase II clinical development program for VX-680 in
colorectal cancer announced today, and the ongoing Phase I study in
hematologic cancers, Merck is also completing a Phase I study of VX-680
administered in patients with solid tumors refractory to prior chemotherapy
treatment.
Background: Aurora Kinases and the VX-680 Collaboration
Cancer cells typically contain mutations in a number of genes, which
ultimately result in uncontrolled cell growth and tumor metastasis. As
enzymes specific for and essential to cell growth and division, Aurora
kinases hold the potential to be important control points for slowing the
growth and spread of tumors. Aurora kinases (A, B and C) comprise a family
of serine-threonine kinases that are believed to play multiple roles in the
development and progression of cancer by acting as regulators of cell
proliferation, by transforming normal cells into cancer cells and by
down-regulating p53, one of the body's natural tumor suppressors. Aurora
kinases are known to be over-expressed in many tumor types, including colon
cancer, breast cancer, ovarian cancer and other cancers as well as in
lymphoma and leukemias. Amplification of Aurora genes is associated with
progression of colorectal cancer and poor prognosis in certain types of
breast cancer.
In June 2004, Vertex entered into a global collaboration with Merck to
develop and commercialize VX-680. Along with clinical development, Vertex
and Merck are conducting a joint research program to characterize VX-680's
activity across a broad range of cancer types and have identified an
additional drug candidate targeting the Aurora kinases.
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.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) Merck expects to initiate a Phase II clinical study for
VX-680 in patients with advanced lung cancer this year; and (ii) Vertex and
Merck will continue to assess the activity of VX-680 in a range of solid
tumors and hematologic cancers. 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-680 may not proceed as
planned due to technical, scientific, or patient enrollment issues, or
disagreements 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-680 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 clinical trials commenced during 2005 and 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, 2006.
Vertex Contacts:
Lynne Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Senior Media Relations Specialist, (617) 444-6470
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com/
http://www.prnewswire.com/comp/938395.html/
CONTACT:
Lynne Brum, Vice President, Strategic
Communications, +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, Senior
Media Relations Specialist, +1-617-444-6470, both of Vertex
Pharmaceuticals Incorporated
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