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Hepatitis C Protease Inhibitor

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  • claudine intexas
    NATAP - www.natap.org Hepatitis C Protease Inhibitor At the large annual hepatitis/liver conference AASLD which was held in November in Boston the first study
    Message 1 of 1 , Jan 2, 2003
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      NATAP - www.natap.org

      Hepatitis C Protease Inhibitor

      At the large annual hepatitis/liver conference AASLD which was held
      in
      November in Boston the first study results in HCV-infected patients
      using an
      HCV protease inhibitor were presented by Boerhinger-Ingleheim
      researchers.
      They reported encouraging results after patients received the
      protease
      inhibitor BILN-2061. Here is a link to NATAP's AASLD conference
      reports
      where
      you'll find 3 articles on the 2 studies conducted:
      http://www.natap.org/2002/AASLD/ndxAASLD.htm

      Below is a press release from Vertex Pharma where they announce that
      they
      look forward to starting a study with their protease inhibitor in
      humans.

      Vertex Pharmaceuticals Restructures Agreement with Eli Lilly; Vertex
      to
      Lead
      Development of Novel Oral Hepatitis C Protease Inhibitor VX-950

      Thursday January 2, 4:05 pm ET -- VX-950 to Enter Clinical Trials in
      2003
      --CAMBRIDGE, Mass., Jan. 2 /CNW/ -- Vertex Pharmaceuticals
      Incorporated
      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
      disclosed."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-950Vertex 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 InfectionHCV 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
      VertexVertex
      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.

      __________________________________________________
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