- Vertex Earns $25 Million Milestone Payment Upon Start of Patient Dosing -
WHITEHOUSE STATION, N.J. and CAMBRIDGE, Mass., Dec. 21
/PRNewswire-FirstCall/ -- Merck & Co., Inc. (NYSE: MRK) and Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the start of an
international clinical trial of MK-0457 (also known as VX-680), an
investigational small molecule inhibitor of Aurora, FLT-3, JAK-2 and
BCR-ABL kinases. The trial will be conducted in patients with treatment
resistant chronic myelogenous leukemia (CML) and Philadelphia
chromosome-positive acute lymphocytic leukemia (Ph+ ALL) containing the
T315I BCR-ABL mutation. In connection with the start of dosing in the
trial, which is designed to support registration of MK-0457 in the United
States and other countries, Vertex earned a $25 million milestone payment
from Merck.
"This pivotal trial based on a population prospectively defined by a
genetic marker will hopefully represent a new paradigm for development of
drugs targeting specific cancer patient populations," said Stephen H.
Friend, M.D., Ph.D., Executive Vice President and Franchise Head, Oncology
and Neuroscience, Merck Research Laboratories. "MK-0457 is the first
compound to show clinical activity in patients with certain
treatment-resistant forms of blood cancers. Based on encouraging Phase 1
results reported recently at the American Society of Hematology meeting, we
are moving forward with this international Phase 2 clinical trial in these
patients."
Clinical Trial Design
Merck will conduct the international Phase 2 clinical trial of MK-0457
at various sites in the United States, the European Union, and several
other countries, including Israel. The trial is expected to enroll
approximately 270 adult patients with advanced CML and ALL leukemias
harboring the T315I BCR-ABL mutation. Patients in the study will be
enrolled in one of four cohorts: patients with accelerated phase CML,
patients with blast phase CML, patients with chronic phase CML and patients
with Philadelphia chromosome-positive ALL with the T315I mutation. In the
trial, MK-0457 will be given as a five-day intravenous infusion every two
to three weeks to evaluate both safety and efficacy. Merck may seek
marketing approval for MK-0457 based on the data generated in this trial.
The trial has been designed to support registration of MK-0457 in one or
more cancer indications for which there is currently little or no effective
treatment.
The trial is now open for patient recruitment. If interested in more
information about the trial, please visit http://www.clinicaltrials.gov or call 1-
888-577-8839. The ClinicalTrials.gov identifier for this trial is
NCT00405054.
Aurora Kinases and Cancer
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 are 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.
Discovery of MK-0457 (VX-680)
MK-0457 was discovered by scientists at Vertex's Oxford, U.K. research
site as part of a broad research effort targeting the kinase gene family.
Vertex researchers published the three-dimensional atomic crystal structure
of Aurora-A kinase in 2002, a key scientific advance that enabled the
design and optimization of multiple classes of small molecule Aurora kinase
inhibitors. MK-0457 advanced to preclinical development in 2002, following
evaluation of the compound's activity in tumor cell lines and in animal
models of tumor growth. In studies published in early 2004, Vertex
demonstrated that MK-0457 induced tumor regression in xenograft models of
human pancreatic and colon cancer. In addition, studies conducted by Vertex
showed that MK-0457 prolonged survival and induced sustained remission in
an oncogene-driven model of human acute myelocytic leukemia (AML).
In June 2004, Vertex entered into a global collaboration with Merck to
develop and commercialize MK-0457 (VX-680) and other follow-on Aurora
kinase inhibitors. As part of the collaboration, Vertex and Merck conducted
a joint research program to characterize MK-0457's (VX-680) activity across
a broad range of cancer types and identified additional drug candidates
targeting the Aurora kinases.
About Merck Oncology
Merck Oncology focuses on all aspects of cancer care -- prevention,
treatment, and supportive care. Through strong internal research
capabilities, selective alliances and acquisitions, and enabling
technologies such as the Molecular Profiling platform of Rosetta, Merck
Oncology is looking to lead in the discovery, development and delivery of
targeted anticancer therapies customized for patient subpopulations. Merck
Oncology conducts research at sites in Boston, Seattle, West Point, Japan
and Italy.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company
dedicated to putting patients first. Established in 1891, Merck currently
discovers, develops, manufactures and markets vaccines and medicines to
address unmet medical needs. The company devotes extensive efforts to
increase access to medicines through far-reaching programs that not only
donate Merck medicines but help deliver them to the people who need them.
Merck also publishes unbiased health information as a not-for-profit
service. For more information, visit http://www.merck.com.
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 focused on viral diseases,
inflammation, autoimmune diseases, cancer, pain and bacterial infection.
Vertex co-discovered the HIV protease inhibitor, Lexiva, with
GlaxoSmithKline. Vertex's press releases are available at http://www.vrtx.com.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Merck forward-looking statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those
set forth in the statements. The forward-looking statements may include
statements regarding product development, product potential or financial
performance. No forward-looking statement can be guaranteed, and actual
results may differ materially from those projected. Merck undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise. Forward-looking
statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in
the cautionary statements in Item 1 of Merck's Form 10-K for the year ended
Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which
the company incorporates by reference.
Vertex forward-looking statement
This press release may contain forward-looking statements, including
statements that (i) Merck will conduct an international clinical trial of
MK- 0457; (ii) this clinical trial may provide a new paradigm for
development of drugs targeting specific cancer patient populations; (iii)
the trial will enroll 270 patients; (iv) data obtained in this trial may
support an application by Merck for marketing approval for MK-0457; and (v)
Aurora kinases hold the potential to be important control points for
slowing the spread and growth of tumors. 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 the
actual results of studies to vary materially. Those risks and uncertainties
include, among other things, the risk that observed outcomes in earlier
clinical investigations of small numbers of patients will not be reflected
in this clinical trial involving larger numbers of patients, that
expectations for regulatory authority support based on possible clinical
trial outcomes will not be realized, either because the outcomes are not as
expected or because the regulatory authority support does not materialize,
that unexpected and adverse outcomes occur in other ongoing clinical and
nonclinical studies, that the expected potential benefits in modulating
Aurora kinase activity are not realized or are accompanied by unacceptable
toxicities, 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
disclaims any obligation to update the information contained in this press
release as new data become available.
Vertex Contacts:
Lynne H. Brum, VP, 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
Merck Contacts:
Media: Michele Rest, (215) 910-2138
Media: Janet Skidmore, (267) 305-7715
Investors: Graeme Bell, (908) 423-5185
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
http://www.merck.com http://www.clinicaltrials.gov
http://www.prnewswire.com/comp/938395.html/
CONTACT:
Lynne H. Brum, VP, 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, all of Vertex
Pharmaceuticals Incorporated; or media, Michele Rest,
+1-215-910-2138, or Janet Skidmore, +1-267-305-7715, or
investors, Graeme Bell, +1-908-423-5185, all of Merck & Co., Inc.
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