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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that five abstracts from its cystic fibrosis (CF) research and development program will be presented at the 27
th Annual North American Cystic Fibrosis Conference (NACFC) in Salt Lake City, Utah, October 17-19, 2013. Data from a Phase 3 study of ivacaftor in non-
G551D gating mutations will be presented as well as long-term safety and efficacy data for KALYDECO™ (ivacaftor) from the PERSIST open-label rollover study. In addition, Fred Van Goor, Ph.D., Head of Biology for Vertex's CF program, and David Rodman, M.D., Vice President of Clinical Development for Vertex's CF program, will participate in invited talks regarding their work to discover and develop medicines that target the underlying cause of CF.
The accepted abstracts are now available in the online edition of
Pediatric Pulmonology: Supplement: The 27th Annual North American Cystic Fibrosis Conference, Salt Palace Convention Center, Salt Lake City, Utah, October 17-19, 2013:
All abstracts will be presented as part of Poster Session 1 on October 17, 11:50 a.m. - 1:50 p.m. MDT:
“Ivacaftor, a CFTR potentiator, in cystic fibrosis patients who have a non- G551D-CFTR gating mutation: Phase 3, Part 1 results.” Poster 241. Vertex also expects these data to be presented as part of Symposium III, “CFTR: Matching CFTR Mutations and Drugs,” on October 19, 10:30 a.m. - 12:20 p.m. MDT.
“Effect of ivacaftor in patients with cystic fibrosis and the G551D-CFTR mutation who have baseline FEV 1 >90% of predicted.” Poster 257.
“Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the G551D-CFTR mutation: response through 144 weeks of treatment (96 weeks of PERSIST).” Poster 227.
“Effect of ivacaftor on circulating inflammatory indices in CF patients with the G551D-CFTR mutation.” Poster 259.
“Evaluation of the drug-drug interaction potential of ivacaftor on a combined oral contraceptive.” Poster 262.
Two additional Vertex presentations will take place as part of invited talks during Symposium Sessions II and III:
“Matching Novel Therapies to CF-Causing Mutations in Cell-based Systems.” Fred Van Goor, Ph.D., will deliver an invited talk during Symposium Session III, “CFTR: Matching CFTR Mutations & Drugs,” on October 19 at 11:30 a.m. MDT.
“Lessons Learned From the Development of First Generation CFTR Modulators.” David Rodman, M.D., will deliver an invited talk during Symposium II, “NT/CFTR: Advances in the Therapeutic Pipeline for CFTR Repair (Combination),” on October 18 at 11:55 a.m. MDT.
About KALYDECOKALYDECO™ (ivacaftor) is the first medicine to treat the underlying cause of CF in people with the G551D mutation in the
CFTR gene. Known as a CFTR potentiator, KALYDECO is an oral medicine that aims to help the CFTR protein function more normally once it reaches the cell surface, to help hydrate and clear mucus from the airways. KALYDECO (150mg, q12h) was first approved by the U.S. Food and Drug Administration in January 2012, by the European Medicines Agency in July 2012, by Health Canada in November 2012 and by the Therapeutic Goods Administration in Australia in July 2013 for use in people with CF ages 6 and older who have at least one copy of the G551D mutation in the CFTR gene.
Vertex retains worldwide rights to develop and commercialize KALYDECO.