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Tuesday January 8, 8:04 am Eastern Time
Vertex Pharmaceuticals Provides Corporate Update and Outlook for 2002
CAMBRIDGE, Mass., Jan. 8 /PRNewswire/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - news) provided an update on its 2001 accomplishments and its outlook for 2002 at the J.P. Morgan H&Q 20th Annual Healthcare Conference in San Francisco. The update was provided by Joshua Boger, Ph.D., Chairman and CEO of Vertex Pharmaceuticals.
(Photo: newscom.com )
``In 2001, we made demonstrable progress across our business,'' stated Joshua Boger, Ph.D., Chairman and CEO of Vertex Pharmaceuticals. ``We greatly enhanced our capabilities in drug discovery through the acquisition of Aurora Biosciences; we advanced and expanded our pipeline by achieving several key product development goals; and we made a number of important hires that brought new talent to the Vertex management team.''
Dr. Boger continued, ``We are well positioned to make progress on multiple fronts in 2002. We believe this progress will drive sustained value creation for shareholders. In the year ahead, we anticipate significant milestones in our product pipeline, including the filing of our next NDA, for GW433908 (VX- 175), in development with GlaxoSmithKline for the treatment of HIV; and continued and expanded development of pralnacasan (HMR 3480/VX-740), an oral cytokine inhibitor in Phase II development with Aventis for the treatment of inflammatory diseases. Furthermore, we expect to initiate three first-in-man studies for drug candidates targeting a broad range of disease areas. We also will continue to capitalize on our drug discovery productivity by advancing four or more additional product candidates from research into our preclinical pipeline, and we envision that many of these will have the potential to be first-in-class oral drugs for the treatment of major diseases with significant unmet medical need.''
Dr. Boger added, ``With approximately 1,000 employees, more than 10 products in our clinical pipeline, and an increasingly productive drug discovery organization, Vertex has reached an important stage in its development. In the coming year, we plan to continue broadening our research capabilities, advancing our pipeline and expanding our executive management team, to pave the way for continued successful growth.''
Product Pipeline Update: Partner-Driven Programs
In 2001, GlaxoSmithKline (GSK) conducted a state-of-the-art Phase III program for GW433908 (VX-175), a novel protease inhibitor for the treatment of HIV, to support worldwide product registration filings. Vertex expects that GSK will file a New Drug Application (NDA) for GW433908 in the second half of 2002.
In the first quarter of 2001, Vertex's partner Aventis began a three- month 250 patient trial of pralnacasan (HMR 3480/VX-740), in rheumatoid arthritis. This study is fully enrolled, and Vertex expects Aventis to complete this study in the first half of 2002. In parallel with current development of this first-in-class oral cytokine inhibitor, Vertex also expects Aventis to initiate a Phase II study of pralnacasan in an additional indication in the first half of 2002.
Product Pipeline Update: Vertex-Driven Programs
Vertex completed a Phase II combination study of merimepodib (VX-497), an oral IMPDH inhibitor for the treatment of hepatitis C virus (HCV), and interferon alpha in 2001. The Company announced today that it plans to start a Phase II triple combination study of merimepodib in the first quarter of 2002. The 12-month combination study will be conducted in Europe. Patients with HCV will be treated with either VX-497 in combination with pegylated interferon and ribavirin, or they will receive placebo in combination with pegylated interferon and ribavirin.
Vertex developed this trial design based on laboratory data and current medical practice:
Vertex generated new in vitro data demonstrating that VX-497 produces an additive antiviral effect in combination with ribavirin and interferon, and
Current medical practice supports multi-drug regimens as a potentially effective HCV treatment option.
In 2001, Vertex obtained clinical proof-of-concept in a Phase II trial of its oral p38 MAP kinase inhibitor, VX-745, in rheumatoid arthritis. Vertex is now advancing the development of second generation p38 MAP kinase inhibitors, VX-702 and VX-850, and expects to begin Phase I clinical testing of one or both of these compounds in the first half of 2002.
In 2001, Vertex conducted a Phase I clinical program of its second generation IMPDH inhibitor, VX-148. The Company expects to begin a Phase II clinical trial of VX-148 in an autoimmune indication in the second half of 2002.
In 2002, Vertex plans to initiate three first-in-man studies for drug candidates targeting a broad range of disease areas.
New Preclinical Candidates
Dr. Boger continued, ``Vertex advanced four compounds into preclinical development in 2001. Several of these new drug candidates have the potential to create entirely new categories of drugs and, as such, represent outstanding commercial opportunities.''
The new drug candidates selected by Vertex in 2001 include:
On January 7, 2002, Vertex and Eli Lilly jointly announced that they have selected VX-950 (LY570310) as their lead drug candidate for the treatment of hepatitis C infection. VX-950 is the first drug development candidate of a new class of antiviral drugs being studied to inhibit hepatitis C NS3-4A protease, an enzyme considered essential for HCV viral replication.
Vertex announced today that it has selected for preclinical development VX-799, a small molecule caspase inhibitor for the treatment of sepsis. As an inhibitor of caspase-mediated programmed cell death (apoptosis), VX-799 represents a novel approach to treating sepsis patients, for whom limited treatment options are available.
Vertex announced today that it has selected for preclinical development VX-563, a small molecule drug candidate with potential application in the treatment of variety of genetic disorders, including sickle cell anemia, Huntington's disease, alpha-1 antitrypsin deficiency, and cystic fibrosis. VX-563 is a potent inhibitor of the enzyme histone deacetylase, and laboratory studies have demonstrated that VX-563 can upregulate cellular production of certain proteins, including proteins that are known to be deficient in human genetic disorders.
Vertex also announced today that it selected for preclinical development VX-385, a small molecule drug candidate for the treatment of an undisclosed viral disease that is being developed in collaboration with one of Vertex's pharmaceutical partners.
Vertex plans to provide further information on all of these new drug candidates in the first quarter of 2002. In addition the Company expects to advance four or more additional drug candidates into preclinical development during 2002.
Progress in Drug Discovery/Kinase Program on Track
``In 2001, we continued to make important progress in our kinase research program as part of our collaboration with Novartis,'' continued Dr. Boger. ``Key research advances include the determination of the three-dimensional atomic structure of glycogen synthase kinase 3 beta (GSK3B), an enzyme involved in the regulation of blood glucose and thus a potentially important diabetes target, which we reported in June. In addition, our medicinal chemistry efforts have enabled us to file patents on more than 340 different chemical scaffolds that inhibit one or more kinases. We look forward to sharing further details of our progress in this program throughout 2002.''
Dr. Boger added, ``Our gene family drug discovery approach is applicable to a number of target-rich gene families. In 2001, we increased our focus on human proteases, a family of approximately 400 targets that includes beta secretase, a target of high interest in the treatment of Alzheimer's disease. Furthermore, our acquisition of Aurora Biosciences is enabling us to expand even further our research in multi-target gene families.''
Aurora Biosciences Acquisition: Significant Progress with Integration of Businesses
``We completed our acquisition of San Diego-based Aurora Biosciences in July 2001 and made significant progress integrating all of our business units during the second half of the year,'' continued Dr. Boger. ``We are optimistic about the drug discovery and business synergies that are taking shape. On the drug discovery side, we will be dedicating significant resources to establish a world class drug discovery program in the ion channel gene family, one of several gene families in which Aurora has considerable expertise. Ion channels represent an outstanding development and commercial opportunity, and we look forward to accelerating our research in this area.''
``From a commercial perspective, Aurora will focus on leveraging its innovative capabilities in assay development, screening, proprietary reagents, proteomics, ADME/Toxicology and advanced technology for enabling drug discovery. The Company's business development activities have been aligned with customer demand. The refocused business model is embodied by the agreement Aurora signed with Allergan last week for assay development and screening in several G protein-coupled receptor (GPCR) targets. Allergan had an existing partnership with Aurora in ion channels, and we are pleased that Allergan has expanded its partnership with Aurora into GPCRs, an additional area of important drug targets. Going forward, we believe Aurora will help unlock value across multiple fronts for Vertex.''
Conclusion
``In summary, Vertex's corporate progress and growth in 2002 will be defined by key accomplishments across our business,'' Dr. Boger concluded. ``We look forward to providing investors with our 2002 financial guidance on our year-end financial results conference call on February 7, 2002, and to providing updates throughout the year.''
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