- VX-409 is first in a new class of subtype selective ion channel modulators -
CAMBRIDGE, Mass., Dec. 13 /PRNewswire-FirstCall/ -- GlaxoSmithKline
(NYSE: GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced
today that they have entered into a new agreement to develop and commercialize
VX-409, Vertex's novel, subtype selective sodium channel modulator for the
treatment of pain. VX-409 is the first of a new class of agents targeting
specific pain signals in nerve cells. Under the terms of the agreement, GSK
will have the exclusive right and license to develop and commercialize VX-409
and back-up compounds worldwide. Vertex will receive a $20 million up-front
payment and could receive up to an additional $385 million in development and
sales threshold milestone payments based on the development of VX-409 and
back-up compounds in major pharmaceutical markets across a range of
indications. GSK will also pay Vertex royalties on annual net sales.
Dr. Jackie Hunter, Senior Vice President, Neurology and GI Centre of
Excellence for Drug Discovery, GSK commented, "This is another example of
GSK's commitment to invest in external opportunities which complement our
existing disease area expertise and maximize our development of innovative and
best-in-class medicines to address unmet medical needs in key clinical areas."
"GlaxoSmithKline is a leader in the development of new treatments for
chronic and acute pain, and we are pleased to join with GSK to develop and
commercialize VX-409 for the treatment of a variety of pain indications," said
Joshua Boger, Ph.D., Chairman, President and CEO of Vertex. "VX-409 may have
the potential to change the future management of pain, based on the clinical
confirmation of the compound's profile."
About VX-409 and Pain
VX-409 is a leading agent in a new class of investigational therapies
targeting pain treatment through selective modulation of sodium channels in
nerve cells. Specific sodium channels are involved in transmitting sensory
input, including the transmission of pain signals to the central nervous
system, making them attractive targets for new pain treatments. As an oral,
subtype selective sodium channel modulator, VX-409 has been shown to be orally
bioavailable, highly active and has exhibited a good safety profile in
nonclinical models of both neuropathic and inflammatory pain. VX-409 was
discovered through Vertex's San Diego-based ion channel research program using
the capabilities and proprietary technologies that are unique to that site.
Phase I clinical development of VX-409 is expected to be initiated early in
2007.
In the United States alone, an estimated 14 million people are affected by
inflammatory pain and three million by neuropathic pain.(1) Worldwide
prescription drug sales for the treatment and management of pain were more
than $20 billion in 2004, and are projected to grow at an estimated 10 percent
annually through 2008.(2) Both neuropathic and inflammatory pain are areas of
major unmet medical need, and a new treatment targeting these areas could
represent a significant product opportunity.
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 Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) Vertex will receive a $20 million up-front payment and
could receive up to an additional $385 million in milestone payments based on
the development and sales of VX-409 and back-up compounds in major
pharmaceutical markets across a range of indications; (ii) GSK will have the
exclusive right and license to develop and commercialize VX-409, and will pay
Vertex royalties on sales of products incorporating compounds covered by this
agreement; (iii) VX-409 may have the potential to change the future management
of pain, based on the clinical confirmation of the compound's profile; and
(iv) Phase I clinical development of VX-409 is expected to be initiated early
in 2007. 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-409 may not proceed as planned due to technical,
scientific, supply or patient enrollment issues, that actual clinical studies
of VX-409 will not reflect the results obtained in nonclinical testing, that
any products resulting from this collaboration will be unsuccessful and
therefore low or no royalty payments will be made to Vertex by GSK, that any
products resulting from this collaboration will not have the anticipated
effect on pain management, due to technical or performance shortcomings or
unanticipated side effects, 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.
(1) "Neuropathic Pain: Painful Diabetic Neuropathy, Postherapeutic
Neuralgia, and HIV-related Neuropathic Pain," Decision Resources,
2004. "Rheumatoid Arthritis," Decision Resources, 2005.
"Osteoarthritis," Decision Resources, 2001.
(2) "Pain Management Therapeutics: A Strategic Market Outlook and
Business Analysis", Frontline Strategic Consulting, 2003.
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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