- Company achieves two milestones in broad collaboration with Merck to develop
VX-680 and Aurora kinase inhibitors -
CAMBRIDGE, Mass., Dec. 7 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced clinical and research progress in
its worldwide collaboration with Merck & Co., Inc. to develop Aurora kinase
inhibitors for the treatment of cancer. In a Phase I clinical study in
patients with solid tumor cancers, dosing with VX-680 (MK-0457) demonstrated
activity on a clinically relevant biomarker, triggering achievement of a
milestone under the contract. VX-680 is a small molecule inhibitor of Aurora
kinases and the lead development compound in the collaboration. In addition,
Merck has selected a follow-on compound for development from a joint Aurora
kinase research program that is part of the collaboration.
In conjunction with this progress, Vertex will receive two milestone
payments from Merck totaling $19.5 million. Vertex expects to recognize
revenue of approximately $7.0 million of the $19.5 million in milestone
payments in the fourth quarter of 2005, and the balance in 2006.
"We are pleased with our progress in the research and development of
Aurora kinase inhibitors, which may represent an exciting new approach to the
treatment of cancer," said Stephen H. Friend, M.D., Ph.D., Executive Vice
President, Advanced Technology & Oncology at Merck Research Laboratories. "We
initiated a number of clinical trials for VX-680 in 2005, and the biomarker
activity observed in the Phase I trial in solid tumors is encouraging. We
look forward to continued progress in the coming year's program as we look to
further define the clinical activity of VX-680 in several potential oncology
indications."
"The rapid achievement of these milestones is an important part of our
goals for the VX-680 program and in realizing our 2005 corporate objectives,"
said Joshua Boger, Ph.D., Chairman, President and Chief Executive Officer of
Vertex Pharmaceuticals. "Working together with Merck, we have successfully
executed on all key clinical and research activities in the program this year.
The progress announced today affirms our view that VX-680 and Aurora kinase
inhibitors have the potential to play an important role in cancer therapy."
VX-680 Clinical Studies
Merck is presently conducting three clinical studies of VX-680 in patients
with hematologic cancers, recurrent or non-responsive solid tumors, or cancers
for which standard therapy does not currently exist. In these studies, the
safety and tolerability of VX-680 are being evaluated when administered as
either a 24-hour continuous infusion or as a 5-day continuous infusion.
Presentation of clinical data from these studies at one or more scientific
conferences is anticipated in 2006.
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 Forward-Looking Statement
This press release may contain forward-looking statements, including
statements that (i) Vertex expects to receive $19.5 million in milestone
payments from Merck and expects to recognize revenue of approximately $7.0
million of the $19.5 million in the fourth quarter of 2005, and the balance in
2006; (ii) the progress announced today affirms the view that VX-680 and
Aurora kinase inhibitors have the potential to play an important role in
cancer therapy; and (iii) presentation of clinical data from the Phase I
studies is anticipated in 2006. 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 the risk that non-clinical
or early clinical results from studies of compounds targeting Aurora kinases
may not be predictive of human clinical results, or later stage clinical
results, in the treatment of cancer, that development of VX-680 may not be
pursued due to clinical, technical or financial issues, that the rate of
patient enrollment may limit expected study timelines and follow-on studies,
that Merck may choose not to develop VX-680 or any other Aurora kinase
inhibitor discovered by Vertex for commercial or scientific reasons, 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's press releases are available at http://www.vrtx.com.
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, Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, Lora Pike,
Manager, Investor Relations, +1-617-444-6755, or Zachry Barber,
Specialist, Media Relations, +1-617-444-6470, all of Vertex
Pharmaceuticals Incorporated
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