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Last $132.20 USD
Change Today +6.65 / 5.30%
Volume 3.1M
As of 8:10 PM 04/21/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

50 Northern Avenue

Boston, MA 02210

United States

Phone: 617-341-6100

Fax:

Vertex Pharmaceuticals Incorporated engages in the business of discovering, developing, manufacturing, and commercializing small molecule drugs. The company uses precision medicine approaches to create transformative drugs for patients with serious diseases in specialty markets. Its business is focused on developing and commercializing therapies for the treatment of cystic fibrosis (CF) and advancing its research and early-stage development programs. CF KALYDECO (ivacaftor) KALYDECO (ivacaftor) is an orally-administered CF transmembrane conductance regulator (CFTR) potentiator that is approved in the United States, Australia, Canada, and the European Union for the treatment of patients six years of age and older with CF who have specific mutations in their CFTR gene. In addition, the company has submitted applications to regulatory authorities to further expand the label for KALYDECO to include patients with CF two to five years of age with specific gating mutations in their CFTR gene and to include patients with CF 18 years of age and older in Europe who have the R117H mutation in their CFTR gene. During development, ivacaftor is granted orphan drug designation in the United States and European Union, and Fast-track designation in the United States. The company uses the brand name KALYDECO only when it refers to the product that has been approved and with respect to the indications on the approved label. In February 2014, the United States Food and Drug Administration (FDA) approved KALYDECO for the treatment of patients with CF six years of age and older who have one of eight other mutations in their CFTR gene, which were studied in the company’s first Phase 3 label-expansion clinical trial for ivacaftor. In July 2014, the European Commission approved KALYDECO for this patient group. In December 2014, the FDA approved KALYDECO for the treatment of patients six years of age and older who have the R117H in their CFTR gene. The company has completed a Phase 3 clinical trial to evaluate ivacaftor as a treatment for children with CF two to five years of age with specific gating mutations in their CFTR gene, including the G551D mutation, and have submitted an NDA (New Drug Application) to the FDA and an MAA (Marketing Authorization Application) line extension application to the EMA (European Medicines Agency) based on this clinical trial. The company also has submitted an MAA variation to the EMA for ivacaftor for patients with CF 18 years of age and older with the R117H mutation in their CFTR gene. Lumacaftor in Combination with Ivacaftor Lumacaftor is an orally-administered CFTR corrector drug candidate that the company is developing in combination with ivacaftor. In November 2014, the company submitted an NDA to the FDA and an MAA to the EMA for lumacaftor in combination with ivacaftor in patients with CF 12 years of age and older who have 2 copies (homozygous) of the F508del mutation in their CFTR gene. In 2015, the company submitted in Canada, and expects to submit in Australia, regulatory applications seeking approval for lumacaftor in combination with ivacaftor. These regulatory applications were based on TRAFFIC and TRANSPORT, two Phase 3 randomized, double-blind, placebo-controlled clinical trials of lumacaftor in combination with ivacaftor. The FDA has granted the company priority review of the NDA and the European Committee for Medicinal Products has granted its request for Accelerated Assessment of the MAA. The company completed TRAFFIC and TRANSPORT in 2014. VX-661 in Combination with Ivacaftor VX-661 is an orally-administered CFTR corrector drug candidate that the company is developing in combination with ivacaftor. In 2015, the company initiated a Phase 3 development program for VX-661 in combination with ivacaftor in patients with CF 12 years of age and older, including patients who are homozygous for the F508del mutation in their CFTR gene and patients with CF who have 1 copy of the F508del mutation in their CFTR gene (heterozygous). CF Research Programs The company is also seeking to identify and develop next-generation CFTR corrector compounds that could be evaluate

 

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Price/Earnings NM Not Meaningful
Price/Sales 51.5x
Price/Book 28.2x
Price/Cash Flow NM Not Meaningful
TEV/Sales 48.5x
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