Vertex protease inhibitor VX-950
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Vertex Pharmaceuticals Restructures Agreement with Eli Lilly; Vertex to Lead
Development of Novel Oral Hepatitis C Protease Inhibitor VX-950
-- VX-950 to Enter Clinical Trials in 2003 --
CAMBRIDGE, Mass., Jan 02, 2003 (Canada NewsWire via COMTEX) -- Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has
restructured its agreement with Eli Lilly and that Vertex will lead
development and commercialization of VX-950, a novel, oral hepatitis C viral
protease inhibitor. Vertex plans to begin clinical testing of VX-950 in the
second half of 2003. Preclinical studies of VX-950, begun in early 2002, are
continuing in preparation for the commencement of Phase I clinical trials.
VX-950 is a small molecule protease inhibitor from a new class of antiviral
drugs that inhibit hepatitis C NS3-4A protease, an enzyme considered
essential for HCV viral replication.
The mutual decision to restructure the agreement is a result of a
reprioritization of Eli Lilly's research portfolio and Vertex's desire to
focus on specialty pharmaceutical markets and retain greater downstream
rights to its own compounds. In order to reflect these strategic priorities,
the companies have restructured their agreement. Vertex has obtained the
worldwide rights to compounds identified during the collaboration. Eli Lilly
will retain a financial interest in VX-950 and other HCV protease compounds
through royalties on future net product sales. Financial terms were not
"Vertex is enthusiastic about the opportunity to drive forward development
and commercialization of this innovative compound. Obtaining worldwide
rights to our HCV protease inhibitor program is an important value creation
step and strengthens our antiviral and infectious disease portfolio. Our
clinical group is well-positioned to move VX-950 into the clinic and
capitalize on the value of our HCV protease inhibitor discovery program,"
said Joshua Boger, Ph.D., Chairman and CEO of Vertex.
"Drugs such as VX-950 could usher in a significant treatment advance and
provide a medical breakthrough for patients with HCV," said John Alam, M.D.,
Vertex's Senior Vice President, Drug Evaluation and Approval. "Recent
clinical data from studies with another company's HCV protease inhibitor
compound have established initial proof-of-concept for small molecule HCV
protease inhibitors. VX-950 is a distinct compound that has shown excellent
in vitro potency, and high levels of drug were achieved in both plasma and
liver in animal studies. We look forward to initiating clinical evaluation
of VX-950 and to beginning to publish key data on Vertex's HCV protease
compounds in the second half of 2003. In addition, we also anticipate that
Vertex's ongoing HCV protease inhibitor discovery program will produce an
additional drug candidate in 2003 suitable for clinical development."
Background on VX-950
Vertex researchers solved the three-dimensional atomic structure of HCV
protease and reported the results in the journal Cell in 1996. In 1997,
Vertex began a collaboration with Eli Lilly that has led to the discovery of
HCV protease inhibitors, and has pioneered novel chemistry and
virology-based approaches to design potent and selective compounds that
block HCV viral replication. Vertex and Lilly employed computational and
combinatorial chemistry techniques to create novel chemical scaffolds, and
Vertex developed a proprietary cell-based assay for compound screening.
VX-950 exhibits potent antiviral activity and promising pharmacological
properties in preclinical testing. During Vertex's collaboration with Eli
Lilly, Vertex has led efforts on HCV protease inhibitor drug design, process
development and pre-commercial drug substance manufacturing work, and has
taken the lead in conducting ongoing toxicology studies. The HCV protease
inhibitor field has received renewed attention in recent months, following
presentation of the first clinical data on another company's HCV protease
inhibitor compound at the American Association for the Study of Liver
Disease (AASLD) meeting in November 2002.
Background on HCV Infection
HCV infection is a serious disease that causes inflammation of the liver,
which may lead to fibrosis and cirrhosis, liver cancer, and ultimately,
liver failure. Chronic hepatitis C infection afflicts approximately 2.7
million people in the U.S., many of whom are unaware of their infected
status. HCV may go undetected for up to 20 years following initial
infection. Worldwide, the disease strikes as many as 185 million people.
Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV.
Current treatments have been effective for only 40 to 60 percent of
chronically infected HCV patients and are associated with significant side
effects. At the present time, there are no direct antiviral therapies
available for the treatment of HCV infection.
Vertex Pharmaceuticals Incorporated is a global biotechnology company.
Vertex seeks to discover, develop, and commercialize major pharmaceutical
products independently and with partners. Chemogenomics, Vertex's
proprietary, systematic, genomics-based platform, is designed to accelerate
the discovery of new drugs and to expand intellectual property coverage of
drug candidate compounds and classes of related compounds. This approach,
which targets gene families, has formed the basis for several commercial
collaborations under which Vertex retains rights to downstream revenue.
Vertex's first approved product is Agenerase(R) (amprenavir), an HIV
protease inhibitor, which Vertex co-promotes with GlaxoSmithKline. Vertex
has more than 12 drug candidates in clinical and preclinical development to
treat viral diseases, inflammation, cancer, autoimmune diseases,
neurological disorders and genetic disorders.
This press release may contain "forward-looking" statements, including
statements that Vertex's HCV protease research program will produce
additional drug candidates, that Vertex anticipates initiating clinical
studies with VX- 950 in the second half of 2003, and that HCV protease
inhibitors could provide a major clinical advance in treatment of HCV. While
Vertex's management uses its best efforts to be accurate in making
forward-looking statements, those statements are subject to risks and
uncertainties that could cause actual results to vary materially. Those
risks and uncertainties include, among other things, the risk that further
research may not be successful in identifying additional drug candidates,
that preclinical studies may not lead to the initiation of Phase I clinical
trials, that clinical trials may not result in a marketable product and that
Vertex may be unable to secure regulatory approval of, or successfully
market, a drug candidate. For further discussion of these and other risks
and uncertainties, see Vertex's filings with the United States Securities
and Exchange Commission. Vertex disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Agenerase(R) is a registered trademark of the GlaxoSmithKline group of
Conference Call and Webcast:
Vertex Pharmaceuticals will host a conference call on January 2, 2003 at
5:00 p.m. ET to discuss this announcement. This call will be broadcast via
the Internet at www.vrtx.com in the investor center.
Vertex's press releases are available at www.vrtx.com.
Lynne H. Brum, Vice President, Corporate Development and
Michele Karpf Belansky, Associate Director, Corporate Brand Management,
Katie Burns, Manager, Investor Relations, (617) 444-6656
Michael Partridge, Director, Corporate Communications, (617) 444-6108
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 201-369-3467/
/Company News On-Call: http://www.prnewswire.com/comp/938395.html/
/Web site: http://www.vrtx.com/
VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
For further information: Lynne H. Brum, Vice President, Corporate
Development and Communications, +1-617-444-6614, or Michele Karpf Belansky,
Associate Director, Corporate Brand Management, +1-617-444-6259, or Katie
Burns, Manager, Investor Relations, +1-617-444-6656, or Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, both of Vertex
News release via Canada NewsWire, Toronto 416-863-9350
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