Cambridge, MA, January 8, 2007– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its key business objectives for 2007 and provided an overview of recent developments, including highlights from research and development programs. Joshua Boger, Ph.D., President and Chief Executive Officer of Vertex Pharmaceuticals, will provide a corporate update at the 25th Annual JPMorgan Healthcare Conference in San Francisco on Tuesday, January 9, 2007. A live webcast of the presentation will be available on Vertex’s website, www.vrtx.com, at 2:00 p.m. PST, January 9, 2007.
“ 2006 was a year characterized by significant clinical progress, including the first clinical data from the global Phase 2 development program, which established telaprevir as a leading investigational drug candidate for hepatitis C virus (HCV) infection,” stated Dr. Boger. “With these important advancements, we are uniquely positioned in 2007 to build Vertex on telaprevir.”
“The initiation of Phase 3 clinical development with telaprevir is our primary objective for 2007. We anticipate that information derived from the PROVE program and other studies will support the design and initiation of a Phase 3 program,” continued Dr. Boger. “More broadly, we are building our capabilities and adding expertise in key areas—clinical development, regulatory affairs, quality control, supply chain management, and commercial development—designed to support an NDA filing in 2008.”
2007 Clinical and Corporate Objectives
Broad clinical development program for telaprevir (VX-950)
VX-702 clinical study in combination with methotrexate in patients with rheumatoid arthritis (RA)
VX-770 advancing to Phase 2 development in cystic fibrosis (CF)
VX-680 (MK-0457) pivotal Phase 2 trial underway in treatment-resistant leukemias
First clinical trial for MK-6592 underway in advanced solid tumors
VX-883, a novel antibiotic active against multi-resistant strains, to enter clinical development in 2007
Review of 2006 Corporate and Clinical Achievements
Vertex will report full-year 2006 financial results and financial guidance for 2007 on February 1, 2007.
Vertex Pharmaceuticals will webcast its corporate presentation at the 25th Annual JPMorgan Healthcare Conference on January 9, 2007 at 2:00 p.m. PST (5 p.m. EST). 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 January 23, 2007.
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 that (i) Vertex is building the foundation for the commercialization of telaprevir; (ii) information from the PROVE program and other studies will support the design and initiation of a Phase 3 development program for telaprevir in 2007; (iii) we are building capabilities in clinical development, regulatory affairs, quality control, supply chain management and commercial development to support an NDA filing in 2008; (iv) PROVE 3 patient recruitment will commence in January; (v) Vertex will expand clinical development of telaprevir to genotype 2 and genotype 3 patients, and initiate a clinical trial exploring twice-daily dosing of telaprevir; (vi) in 2007, Vertex will initiate in the first quarter of 2007 a Thorough QTc study of VX-702 under an open investigational new drug application and that ongoing or planned studies of VX-702 will support the design of late-stage clinical trials for VX-702; (vii) Vertex expects to begin in early 2007 a Phase 2 clinical trial of VX-770 in patients with CF; (viii) the pivotal Phase 2 clinical trial with VX-680 (MK-0457) in as many as 270 patients with treatment-resistant chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphocytic leukemia will support registration of VX-680 in one or more cancer indications for which there is currently little or no effective treatment; (ix) in 2007, Vertex will commence preclinical development for VX-883, and that it will initiate a Phase 1 clinical trial of VX-883 in 2007; and (x) Vertex will report full-year 2006 financial results and financial guidance for 2007 on February 1, 2007. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause the actual results of studies to vary materially. Those risks and uncertainties include, among other things, that the Company’s study objectives for each of its planned studies may not be achieved, that regulatory authorities may not allow the Company’s planned trials to proceed as designed, due to varying interpretations of existing and expected data or disagreements over trial design or for other reasons, that enrollment may be more difficult or slower than the Company currently anticipates or that planned studies may not start when planned due to regulatory issues, site startup delays, availability of clinical trial material or other reasons, or other risks listed under Risk Factors in Vertex’s Form 10-K filed with the Securities and Exchange Commission on March 16, 2006. Vertex disclaims any obligation to update the information contained in this press release as new data become available.
Lynne H. Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Media Relations Specialist, (617) 444-6470