-- Vertex earns $10 million milestone payment --
CAMBRIDGE, Mass., April 5 /CNW/ -- 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
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/Web site: http://www.vrtx.com/
