Back grey_arrow_rt.gif
 
 
Telaprevir Update- FDA filing second half of 2010
 
 
 
 
Vertex Pharmaceuticals Reports 2009 Financial Results and Highlights Recent Progress in Hepatitis C and Cystic Fibrosis Development Programs -HCV: New Drug Application planned for telaprevir in second half of 2010; increasing investment in commercialization and launch preparedness activities-
 
HCV HIGHLIGHTS

 
Mr. Emmens continued, "Our primary focus remains on the completion of the telaprevir Phase 3 development program and the subsequent submission of a New Drug Application for telaprevir, planned for the second half of 2010. In addition, we plan to initiate a clinical trial evaluating combination regimens of telaprevir and VX-222 aimed at further driving the evolution of HCV care, and we look forward to obtaining interim clinical data from the trial in the third quarter of 2010.
 
"Our commitment to improving patient care for those with serious diseases extends beyond HCV and CF. Vertex is also conducting proof-of-concept clinical trials with novel compounds targeting rheumatoid arthritis and epilepsy, and we expect to generate initial clinical data from these trials later in 2010, which could provide important insight into the value of these compounds to patients and to Vertex."
 
Dosing Complete in Phase 3 Registration Program for Telaprevir
 
-- All patients in the Phase 3 ADVANCE, ILLUMINATE and REALIZE clinical trials of telaprevir have now completed dosing of all study drugs, including pegylated-interferon (peg-IFN) and ribavirin (RBV), and are in the post-treatment follow-up period to determine the number of patients who achieve SVR (defined as undetectable HCV RNA 24 weeks after the end of treatment).
 
Planned Phase 2 Trial of Telaprevir/VX-222-based Combination Regimens Upon completion of ongoing late-stage discussions with the U.S. FDA and other global regulatory authorities, Vertex plans to initiate a combination trial of telaprevir and VX-222 in the first quarter of 2010. This trial is expected to evaluate SVR rates using multiple regimens of telaprevir/VX-222-based therapy in HCV patients.
 
"With a cash position of approximately $1.3 billion entering 2010, Vertex is investing in key activities to support the potential launch of telaprevir and to move the company toward its near-term and long-term business objectives," said Ian Smith, Executive Vice President and Chief Financial Officer of Vertex. "As we near completion of the Phase 3 development program for telaprevir, we are increasing our investment in critical pre-launch activities, including building of product supply, the further expansion of our commercial infrastructure and the hiring of key employees to support the implementation of commercial functions. Additionally, we plan to continue investing in research and development to support proof-of-concept clinical trials in HCV
 
 
 
 
  icon paper stack View Older Articles   Back to Top   www.natap.org