Vertex Pharmaceuticals Inc (VRTX)

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Vertex Pharmaceuticals Reports Second Quarter 2009 Financial Results and Highlights Recent Clinical Progress and Business Development Activity
- Telaprevir Phase 3 registration program in hepatitis C on track; NDA submission anticipated in second half of 2010 -

- Vertex advancing two drug candidates aimed at the underlying disease mechanism of the orphan disorder cystic fibrosis -

- Vertex ends second quarter with $754 million of cash, cash equivalents and marketable securities; Vertex will add to this position with $105 million of cash through an amended agreement with Mitsubishi Tanabe Pharma Corporation -

Press Release
Source: Vertex Pharmaceuticals Incorporated
On Wednesday August 5, 2009, 4:01 pm EDT

Companies:Vertex Pharmaceuticals Incorporated
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended June 30, 2009.

“Our top priority is to execute on the telaprevir Phase 3 registration program in hepatitis C and to prepare for a New Drug Application submission in the second half of 2010,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. “Beyond HCV, we are now conducting a comprehensive program in cystic fibrosis - a life-threatening orphan disorder - with two novel therapies that target the underlying disease mechanism. With the advancement of our pipeline and continued research productivity, we are moving closer to fulfilling our corporate vision of building a profitable, fully-capable biopharmaceutical company focused on improving patient outcomes in areas of serious unmet medical need.”

Mr. Emmens continued, "Vertex enters the second half of 2009 in a strong financial position that will enable continued investment into late-stage development opportunities for HCV and CF and into product creation from research. We continue to closely manage our cash investment in the Company and will add $105 million to our financial position through an amended agreement with Mitsubishi Tanabe for the development and commercialization of telaprevir in Asia.”

Broad Commitment to Hepatitis C

Telaprevir Phase 3 registration program on track

Treatment-naïve Phase 3 trials


Vertex is conducting the Phase 3 ADVANCE study, which is evaluating the hepatitis C virus (HCV) protease inhibitor telaprevir, or placebo, as part of a 24-week combination regimen with pegylated interferon (peg-IFN) and ribavirin (RBV) in more than 1,050 genotype 1 treatment-naïve HCV patients. Based upon the completion of enrollment in October 2008, the telaprevir dosing portion of the ADVANCE trial is complete, and all patients are now beyond week 24 of the study. Patients receiving telaprevir-based regimens in the ADVANCE study will receive 24 or 48 weeks of total therapy, depending on whether they have undetectable virus levels at weeks 4 and 12 of treatment. The ADVANCE trial will remain blinded through the last patient completing week 72 in the study. The Company expects sustained viral response (SVR) 24 data to become available from ADVANCE in the first half of 2010.
Vertex is also conducting ILLUMINATE, a global two-arm trial that is evaluating response-guided telaprevir-based regimens in approximately 500 genotype 1 treatment-naïve HCV patients. This trial is designed to supplement SVR data obtained from the pivotal Phase 3 ADVANCE trial. The aim of the ILLUMINATE trial is to characterize whether there is an additional benefit to extending treatment from 24 to 48 weeks in treatment-naïve patients who achieved undetectable virus levels at weeks 4 and 12 of treatment (eRVR). Based upon the completion of enrollment in January 2009, the telaprevir dosing portion of the ILLUMINATE trial is complete, and all patients are now beyond week 24 of the study. The Company expects SVR24 data to become available from ILLUMINATE in the first half of 2010.

Treatment-failure Phase 3 trial


Vertex’s collaborator Tibotec is conducting the Phase 3 REALIZE trial, which is evaluating treatment with telaprevir-based regimens in more than 650 patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment, and which enrolled all major treatment-failure groups including null responders. Based upon the completion of enrollment in February 2009, the telaprevir dosing portion of the REALIZE trial is complete, and all patients are now beyond week 20 of the study. The Company expects SVR24 data to become available from REALIZE in mid-2010.

Telaprevir twice-daily evaluation


Vertex expects that final SVR24 data from Study C208, which is evaluating twice-daily telaprevir dosing, will be presented at a Presidential Plenary session at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston. Study C208 is a Phase 2, open-label clinical study being conducted by Tibotec in Europe that is evaluating a twice-daily (1125mg q12h) dosing schedule of telaprevir in combination with peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON™) and RBV, as compared to the current three-times-daily (750mg q8h) telaprevir dosing schedule. All dosing of study medications was completed in Study C208 in April. Patients are now in the post-treatment follow-up phase to determine the number of patients who achieve an SVR24 with twice-daily compared to three-times-daily dosing of telaprevir.

Additional telaprevir clinical studies


Vertex has completed PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment. Full data from PROVE 3 have been provided to the U.S. Food and Drug Administration.
All patients in Study 107, an open-label Phase 2 study to evaluate telaprevir-based combination regimens in patients who did not achieve an SVR in the 48-week control arms of the Phase 2 PROVE studies, have completed 24 weeks of dosing. In the study, telaprevir was given in combination with peg-IFN and RBV for 12 weeks followed by peg-IFN and RBV for 12 weeks or 36 weeks depending on the patient’s antiviral response to telaprevir in Study 107 and whether the patient was a prior non-responder, partial-responder or relapser. Vertex anticipates that additional data, including SVR24 data, from Study 107 will become available in 2010.

STAT-C combination therapies


Vertex is seeking to advance HCV therapy through the development of novel combinations of Specifically-Targeted Antiviral Therapies for hepatitis C (STAT-Cs). The Company plans to begin a combination trial of telaprevir with the HCV polymerase inhibitor VX-222 (formerly VCH-222) in patients with genotype 1 HCV as early as the fourth quarter of 2009.
Vertex expects data from this first STAT-C combination study to become available in the first half of 2010.
Vertex is currently conducting a three-day, multiple-dose viral kinetic study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of VX-222 dosed as a monotherapy in 32 treatment-naïve patients with genotype 1 HCV infection. This study is scheduled for completion in the third quarter of 2009. Additionally, Vertex expects to initiate a drug-drug interaction study with VX-222 and telaprevir in healthy volunteers in the third quarter of 2009.

Additional HCV compounds in clinical development


Vertex is conducting early-stage development activities with novel HCV compounds, including the additional HCV protease inhibitors VX-813 and VX-985 as well as the HCV polymerase inhibitor VX-759 (formerly VCH-759). Vertex also has an NS5A inhibitor program in preclinical development. The goal of these programs is to identify compounds that are appropriate for further development, including combination therapy.

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