Vertex Pharmaceuticals Inc was incorporated in 1989. The Company is engaged in the business of discovering, developing, manufacturing and commercializing small molecule drugs for patients with serious diseases in specialty markets. It is focused on developing and commercializing therapies for the treatment of cystic fibrosis and advancing its research and early-stage development programs. The Company has marketed KALYDECO (ivacaftor) since it was approved in 2012 for the treatment of certain patients with CF and is seeking approval to market lumacaftor in combination with ivacaftor in order to increase the number of patients with CF who would be eligible for treatment with the Company's drugs. It is engaged in a number of other research and early-stage development programs, including programs in the areas of oncology and neurology. The Company's three products are INCIVE (telaprevir), which is approved for the treatment of patients with genotype 1 hepatitis C virus, or HCV, infection; and KALYDECO (ivacaftor), which is approved in the United States for the treatment of patients six years of age and older with cystic fibrosis, or CF, who genetic mutation in their cystic fibrosis transmembrane conductance regulator, or CFTR, gene, which is referred to as the G551D mutation. INCIVEK is approved in the United States and Canada for the treatment of adults with genotype 1 hepatitis C virus, or HCV, infection and ORKAMBI. The Company began marketing ORKAMBI (lumacaftor in combination with ivacaftor) in the United States in 2015. In November 2015, the European Commission approved ORKAMBI, and the Company is seeking country-by-country reimbursement for ORKAMBI in Europe. As the Company markets and sells its approved products and advances its drug candidates through clinical development toward commercialization, it continues to build and maintain its supply chain and quality assurance resources. It faces competition based on the safety and efficacy of its products and drug candidates, the timing and scope of regulatory approvals, the availability and cost of supply, marketing and sales capabilities, reimbursement coverage, price, patent protection and other factors. Its registered trademarks include Vertex, KALYDECO and INCIVEK. The research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, safety monitoring, record keeping, promotion, advertising, distribution and marketing of its products and drug candidates are subject to extensive regulation by United States and foreign governmental authorities.
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