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12005Vertex protease inhibitor VX-950

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  • Mark Middle Mountain
    Jan 3, 2003
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      Company News

      Vertex Pharmaceuticals Incorporated Nasdaq-NM

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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.

      About Vertex

      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.
      Vertex Contacts:
      Lynne H. Brum, Vice President, Corporate Development and
      (617) 444-6614
      Michele Karpf Belansky, Associate Director, Corporate Brand Management,
      (617) 444-6259
      Katie Burns, Manager, Investor Relations, (617) 444-6656
      Michael Partridge, Director, Corporate Communications, (617) 444-6108
      /Photo: NewsCom:
      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/

      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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