Press Release
Vertex Pharmaceuticals Reports 2007 Pipeline Progress
CAMBRIDGE, Mass., Jun 12, 2007 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today detailed recent progress in its clinical pipeline in conjunction with its participation at the Goldman Sachs 28th Annual Healthcare Conference. A live webcast of Vertex's presentation will be available on Vertex's website, www.vrtx.com, beginning at 2:00 p.m. PDT (5:00 p.m. EDT) on June 13, 2007.
"In the first half of 2007, we have made significant progress in advancing our business and in the development of our pipeline," said Joshua Boger, Ph.D., Vertex's President and Chief Executive Officer. "Specifically, we have enrolled more than 1,000 patients in the PROVE studies evaluating telaprevir, our investigational hepatitis C protease inhibitor, and more than 350 patients have now completed 12 weeks of telaprevir-based dosing. Today, we announced the completion of enrollment in PROVE 3. We are now focused on discussions with regulatory agencies in the U.S. and Europe to enable transitioning to the start of Phase 3 development of telaprevir planned for the fourth quarter of this year."
Mid-2007 Pipeline Update
Broad clinical development program for telaprevir (VX-950)
-- The PROVE clinical program, consisting of three major Phase 2b
trials, is designed to evaluate: 1) the optimal SVR
(sustained viral response) rate that can be achieved with
telaprevir-based therapy; 2) the optimal treatment duration for
telaprevir; 3) the safety profile of telaprevir; and 4) the role of
ribavirin in telaprevir-based therapy. In its program for
treatment-naive patients, Vertex is focused on evaluating regimens
of 24 weeks total duration, with the inclusion of ribavirin in the
treatment combination.
-- The PROVE 1 clinical trial is continuing on track in the U.S.
PROVE 1 is a randomized, placebo-controlled trial that enrolled
250 treatment-naive genotype 1 patients with hepatitis C.
Vertex anticipates completing a planned interim analysis in
July 2007 for patients in the 24-week treatment arm of this
trial. The interim analysis will focus on 12-week
post-treatment antiviral results, and Vertex expects that these
data will be presented at a medical meeting later in 2007.
-- The PROVE 2 clinical trial is also continuing on track in
Europe. PROVE 2 is a randomized, placebo-controlled trial that
enrolled approximately 240 genotype 1 treatment-naive HCV
patients on telaprevir-based regimens and 80 patients who were
randomized to receive pegylated interferon alfa 2a (peg-IFN)
and ribavirin (RBV). Vertex recently received preliminary data
from the first planned interim analysis of PROVE 2, and expects
that these data will be presented at a medical meeting later in
2007. At this time, Vertex is reporting that the preliminary
results are consistent with findings reported for PROVE 1.
Patients in the treatment arms that included telaprevir,
peg-IFN and RBV had rates of undetectable HCV RNA (10 IU/mL)
at 4 and 12 weeks similar to those observed in PROVE 1. The
adverse events observed in the PROVE 2 trial, and the rate of
treatment discontinuations for 240 patients through 12 weeks of
telaprevir-based dosing, appear consistent with the PROVE 1
results reported by Vertex in April. At 12 weeks, the treatment
arm in PROVE 2 that did not include ribavirin was associated
with antiviral activity that was lower compared to treatment
arms that included ribavirin, telaprevir, and peg-IFN, but
still substantially higher than that observed in the control
arm. As reported for PROVE 1, rash, gastrointestinal events and
anemia were the most common events leading to discontinuation
in the telaprevir arms. Fewer discontinuations due to adverse
events were observed in patients receiving telaprevir and
peg-IFN without ribavirin.
-- Vertex today announced that it has completed patient enrollment
in the PROVE 3 clinical trial with more than 440 patients.
PROVE 3 is a Phase 2b clinical trial of telaprevir in patients
with genotype-1 HCV who have not achieved SVR with a previous
interferon-based treatment.
-- With the completion of enrollment in PROVE 3, there are more
than 1,000 patients enrolled in the PROVE clinical program for
telaprevir and, to date, more than 350 patients who have
completed 12 weeks of telaprevir-based dosing.
-- Vertex and Tibotec, with whom Vertex is collaborating to
develop and commercialize telaprevir in Europe and other
countries, are using available data on telaprevir to design a
comprehensive Phase 3 clinical trial program for telaprevir.
Pending additional data from the PROVE program, and the outcome
of discussions with regulatory agencies, the start of an
international Phase 3 clinical trial for telaprevir in genotype
1 treatment-naive patients is planned for the fourth quarter
of 2007.
-- In May, Vertex successfully completed drug substance
registration batches of telaprevir. The Company has also
started the manufacturing validation process for telaprevir
drug substance and expects to complete the validation by the
end of the year. Vertex continues to make a significant
investment to prepare for the commercial supply and marketing
of telaprevir, subject to its continued progress.
-- VX-770 in Phase 2 development in cystic fibrosis (CF)
-- In the second quarter, Vertex initiated a Phase 2a clinical
trial with VX-770. The randomized, double-blind,
placebo-controlled trial of VX-770 will evaluate the safety,
pharmacokinetics and certain biomarkers of CFTR activity in
approximately 35 CF patients with genotype G551D.
-- MK-0457 (VX-680) Phase 2 trial underway in certain
treatment-resistant leukemias
-- Vertex's collaborator Merck is conducting a 270-patient Phase
2 clinical trial with MK-0457 in patients with
treatment-resistant chronic myelogenous leukemia (CML) and
Philadelphia chromosome-positive acute lymphocytic leukemia
(PH+ ALL) containing the T315I BCR-ABL mutation. Enrollment is
underway for this study at 12 clinical centers in the U.S.,
Europe, the Middle East and Asia.
-- Early-stage compounds
-- Vertex has commenced preclinical activities with several novel
compounds now emerging from its drug discovery operations.
Vertex expects to initiate clinical trials of these compounds
by the end of 2007.
Webcast:
Vertex Pharmaceuticals will webcast its corporate presentation at the Goldman Sachs Healthcare Conference on June 13, 2007 at 2:00 p.m. PDT (5:00 p.m. EDT). A link to the live webcast will be available via Vertex's website, www.vrtx.com, in the Investor Center. An archived webcast of the presentation will be available on Vertex's website through June 27, 2007.
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 focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
Safe Harbor Statement
This press release may contain forward-looking statements, including statements concerning (i) our expectations regarding clinical trials, development timelines and discussions with regulatory authorities related to telaprevir and other drug candidates currently under development by us and our collaborators or planned for development; (ii) our expectations about the number of patients that will be evaluated and the data that will be generated by ongoing and planned clinical trials of telaprevir, and the ability to use that data for the design and initiation of further clinical trials; (iii) our expectations regarding the scope and timing of ongoing and potential future clinical trials, including the ongoing Phase 2b clinical trials and expected Phase 3 clinical program for telaprevir, the planned Phase 2a clinical trial of VX-770 and the ongoing clinical trials of MK-0457 (VX-680); (iv) our expectations regarding the progress of our manufacturing activities for telaprevir; and (v) our expectation that final analysis of PROVE 2 results will be consistent with PROVE 1. While we believe the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of our planned clinical trials and studies, and in particular our planned clinical trials of telaprevir, may not be favorable, that one or more of our internal or external drug development programs will not proceed as planned for technical, scientific or commercial reasons, and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through our website at www.vrtx.com. We disclaim any obligation to update the information contained in this press release as new data become available.
Vertex's press releases are available at www.vrtx.com.
(VRTX-GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated Lynne H. Brum, 617-444-6614 Vice President, Strategic Communications or Michael Partridge, 617-444-6108 Director, Corporate Communications or Lora Pike, 617-444-6755 Manager, Investor Relations or Zachry Barber, 617-444-6470 Senior Media Relations Specialist
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