Final Data From Phase 2 Combination Study Of VX-809 And KALYDECO™ (ivacaftor) Showed Statistically Significant Improvements In Lung Function In People With Cystic Fibrosis Who Have Two Copies Of The F508del Mutation
Conference Call for Media and Investors
Vertex will host a conference call and webcast today, June 28, 2012 at 8:00 a.m. ET to discuss these data. The conference call will be webcast live and a link to the webcast may be accessed from the ‘Events & Presentations' page of the Vertex website at www.vrtx.com.
To listen to the live call on the telephone, dial 1-877-250-8889 (United States and Canada) or 1-720-545-0001 (International). To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.
The conference ID number for the live call and replay is 95886622.The call will be available for replay via telephone commencing June 28, 2012 at 12:00 p.m. ET running through 5:00 p.m. ET on July 5, 2012. The replay phone number for the United States and Canada is 1-855-859-2056. The international replay number is 1-404-537-3406. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. ET on July 11, 2012. Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com. About Cystic Fibrosis Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 30,000 people in the United States and 70,000 people worldwide. Today, the median predicted age of survival for a person with CF is approximately 38 years, but the median age of death remains in the mid-20s. CF is caused by defective or missing CFTR proteins resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes – one from each parent – to have CF. There are more than 1,800 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The absence of working CFTR proteins results in poor flow of salt and water into and out of the cell in a number of organs, including the lungs. In people with the most common mutation in the CFTR gene, F508del, little to no CFTR protein reaches the cell surface. As a result, thick, sticky mucus builds up and blocks the passages in many organs, leading to a variety of symptoms. In particular, mucus builds up and clogs the airways in the lungs, causing chronic lung infections and progressive lung damage. VX-809, known as a CFTR corrector, is believed to help CFTR proteins reach the cell surface. KALYDECO, known as a CFTR potentiator, keeps the CFTR protein channels open longer to increase the flow of salt and water into and out of the cell. Globally, nearly half (46 percent) of people with CF have two copies of the F508del mutation and an additional one-third (33 percent) have one copy of the F508del mutation. About KALYDECO KALYDECO™ (ivacaftor) is the first treatment to target the underlying cause of CF. KALYDECO (150mg, q12h) was approved by the U.S. Food and Drug Administration in January 2012 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. In May 2012, Vertex received a positive opinion by consensus from the European Committee for Medicinal Products for Human Use (CHMP) recommending approval. Vertex is also preparing to submit a regulatory filing in Australia in the third quarter of 2012.
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