Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) 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
On January 8, 2012, Vertex provided a comprehensive update on the status of its development programs. The company today provided the following additional updates:
- FDA Approval of KALYDECO: On Tuesday, Vertex announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO TM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF). KALYDECO was approved for people with cystic fibrosis ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene. The approval of KALYDECO was one of the fastest approvals ever by the FDA and marks the second approval of a new medicine from Vertex within the past nine months. Vertex today announced it has begun shipping KALYDECO to pharmacies in the United States.
- 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 and Canada. 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 ®.
- Study of Second Corrector VX-661 Underway for Cystic Fibrosis: Vertex recently initiated a Phase 2 study of VX-661, a second CFTR corrector. The study will evaluate VX-661 as monotherapy followed by dosing of VX-661 in combination with KALYDECO in people with two copies of the F508del mutation. According to the 2010 Cystic Fibrosis Foundation Patient Registry Annual Data Report, approximately 48 percent of the total CF patient population in the United States have two copies of the F508del mutation and an additional 40 percent of the total CF patient population have one copy of the F508del mutation. A Phase 2 study of the CFTR corrector VX-809 dosed in combination with KALYDECO is also ongoing. Data from the study with VX-809 are expected mid-year, followed by data from the study with VX-661 later in 2012.
Other Ongoing and Planned Clinical Studies for 2012:
- Cystic Fibrosis: Vertex plans to conduct three additional studies of KALYDECO that will enroll children with CF as young as two years of age and people with CF who have certain CFTR mutations that were not evaluated in the previous Phase 3 studies.
- 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.
- Rheumatoid Arthritis: Pending final regulatory feedback, Vertex plans to initiate a global Phase 2b study of VX-509 in people with moderate to severe rheumatoid arthritis that will evaluate once and twice-daily dosing in combination with methotrexate.
- Influenza: Following the completion of Phase 1 studies in healthy volunteers , Vertex plans to begin a Phase 2a study of VX-787 in influenza.
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