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Phase 3 Study of VX-770 Shows Marked Improvement in Lung Function Among People with Cystic Fibrosis with G551D Mutation
Date:2/23/2011

s disease, but these data are extremely exciting, especially for people with the G551D mutation and their families. The results also offer significant hope that a similar approach to treatment may help the majority of patients living with CF."

The Phase 3 data support Vertex's plan to submit a New Drug Application for VX-770 to the U.S. Food and Drug Administration (FDA) in the second half of 2011. Generally, the FDA takes between 6 and 12 months to review and rule on a drug application.

"The Cystic Fibrosis Foundation has played an instrumental role in our more than 10-year effort to discover and develop potential new CF medicines such as VX-770," said Matthew W. Emmens, chairman, president and CEO of Vertex. "The data announced today reflect a significant investment of time, dollars and scientific expertise from both Vertex and the CF Foundation, and we look forward to working closely with the Foundation as we seek to bring VX-770 to people with CF."

Said Preston W. Campbell III, M.D., executive vice president for medical affairs of the Cystic Fibrosis Foundation: "As a physician who has treated CF patients for many years, the VX-770 results are more than just numbers -- they represent hope." He added, "It's not surprising that patients felt better on the drug because of the magnitude of lung function improvement and weight gain. These are important clinical outcomes, and the fact they were maintained through 48 weeks is very encouraging."

Developing a therapy for individuals with the most common CF mutation, Delta F508, remains a top priority of the CF Foundation. A Phase 2 trial for those with Delta F508 is underway to test VX-770 in combination with a drug known as VX-809. Like VX-770, VX-809 resulted from discovery efforts between Vertex and the CF Foundation. Laboratory studies suggest a combination of the two drugs may be more beneficial than either one alone. Results of this clinical trial are expected later this year.


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SOURCE Cystic Fibrosis Foundation
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