Vertex reports fourth quarter and full-year 2011 financial results (Vertex) - Feb 2, 2012 - Vertex announced the consolidated financial results for the fourth quarter and full-year ended December 31, 2011; Vertex expects to have on-treatment and SVR4 data from the all-oral, interferon-free arms (VX-222, INCIVEK & ribavirin) of P2 ZENITH study in the Q1 2012; Vertex expects first data from P1 study of ALS-2200 and ALS-2158 in healthy volunteers & genotype 1 pts in Q2 2012; Data from studies in other genotypes are expected later in 2012; Vertex plans to conduct P2 studies to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK or VX-222
Anticipated P1 data • Anticipated P2 data • Anticipated P2 trial • Financial update • Hepatitis C Virus
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Vertex Pharmaceuticals Incorporated today reported consolidated financial results for the fourth quarter and full-year ended December 31, 2011.
"The successful launch of INCIVEK in hepatitis C and rapid approval of KALYDECO for people with a specific type of cystic fibrosis underscore our ability to discover and develop breakthrough new medicines and to bring them to patients," said Jeffrey Leiden, M.D., Ph.D., President and Chief Executive Officer of Vertex. "We will continue to advance our pipeline of eight other potential medicines and expect to generate proof-of-concept data for many of these programs throughout 2012. With two approved medicines and our broad pipeline, Vertex is well-positioned to become a global business focused on creating additional medicines for people with serious diseases."
Development Program Updates
• Global Availability of INCIVEK for Hepatitis C: INCIVEK® (telaprevir) is now approved in the United States for certain adults with hepatitis C and in multiple countries outside the United States. Vertex has exclusive rights to INCIVEK in the United States andCanada. Vertex's collaborator, Janssen, is marketing telaprevir in Europe as INCIVO®. INCIVO is now available in the U.K., Germany, France, Sweden, Austria, Finland, Denmark, Switzerland and Norway. Vertex's collaborator Mitsubishi Tanabe Pharma has rights in Japan, where telaprevir is being marketed as TELAVIC®.
• Other Ongoing and Planned Clinical Studies for 2012:
Hepatitis C: Vertex expects to have on-treatment and SVR4 data from the all-oral, interferon-free arms (VX-222, INCIVEK and ribavirin) of the Phase 2 ZENITH study in the first quarter of 2012. Vertex expects to have the first data from Phase 1 safety and 7-day viral kinetic studies of the nucleotide analogues ALS-2200 and ALS-2158 in healthy volunteers and people with genotype 1 hepatitis C in the second quarter of 2012. Data from studies in other genotypes are expected later in 2012. Following these Phase 1 studies, Vertex plans to conduct Phase 2 studies that are expected to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK or VX-222, potential dual nucleotide regimens and other interferon-free combination regimens that may also include ribavirin.
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