Incyte Corporation, a biopharmaceutical company, focuses on the discovery, development and commercialization of proprietary small molecule drugs to treat serious unmet medical needs. The company has discovered multiple potent, selective and orally bioavailable JAK (janus associated kinases) inhibitors that are selective for JAK1 and JAK2. Its most advanced compound, JAKAFI (ruxolitinib), an oral JAK inhibitor, was synthesized in 2005, and in November 2011, it was approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. JAKAFI JAKAFI became commercially available in the United States in 2011 and is being marketed in the United States through the company’s own specialty sales force and commercial team. To help ensure that all eligible MF patients have access to JAKAFI, the company has established a patient assistance program called IncyteCARES (CARES stands for Connecting to Access, Reimbursement, Education and Support). IncyteCARES helps ensure that any patient with intermediate or high-risk MF who meets certain eligibility criteria and is prescribed JAKAFI has access to the product regardless of ability to pay and has access to ongoing support and educational resources during their treatment. In addition, IncyteCARES works closely with payers to help facilitate insurance coverage of JAKAFI. Clinical Programs JAK Programs for Myeloproliferative Neoplasms, Oncology and Inflammation The company has discovered multiple potent, selective and orally bioavailable JAK inhibitors that are selective for JAK1 and JAK2. Its lead JAK inhibitor for hematologic and oncology indications, JAKAFI (ruxolitinib), is FDA-approved for use in patients with intermediate or high-risk MF and is in Phase III development for polycythemia vera. The compound is also in Phase II development for solid tumors and other hematologic malignancies, and the company has ongoing Phase II trials in patients with MF, polycythemia vera and essential thrombocythemia. License Agreements Novartis Pharmaceutical International Ltd. (Novartis): In November 2009, the company entered into a collaboration and license agreement with Novartis. Under the terms of the agreement, Novartis received exclusive development and commercialization rights outside of the United States to ruxolitinib and certain back-up compounds for hematologic and oncology indications, including all hematological malignancies, solid tumors and myeloproliferative diseases. The company retained exclusive development and commercialization rights to JAKAFI (ruxolitinib) in the United States and in certain other indications. Novartis also received worldwide exclusive development and commercialization rights to c-MET inhibitor compound INCB28060 and certain back-up compounds in all indications. The company retained options to co-develop and to co-promote INCB28060 in the United States. Lilly: In December 2009, the company entered into a license, development and commercialization agreement with Lilly. Under the terms of the agreement, Lilly received exclusive worldwide development and commercialization rights to baricitinib and certain back-up compounds for inflammatory and autoimmune diseases. Pfizer Inc. (Pfizer): In January 2006, the company entered into a collaborative research and license agreement with Pfizer Inc. for the pursuit of CCR2 antagonist program. Pfizer gained worldwide development and commercialization rights to the company’s portfolio of CCR2 antagonist compounds. Pfizer's rights extend to the full scope of potential indications, with the exception of multiple sclerosis and autoimmune nephritides, where the company retained worldwide rights, along with certain compounds. Strategy The company’s strategy is to develop and commercialize its compounds on its own in selected markets, such as in myelofibrosis, other myeloproliferative neoplasms, other oncology indications and certain inflammatory conditions. Research and Development During 2012, the company incurred research and development expenses of $210.4 million. Regulation Research and Development: The company’s ongoing research and development activities and any manufacturing and marketing of JAKAFI and its product candidates are subject to regulation by governmental authorities in the United States and other countries. Before marketing in the United States, any drug developed by the company must undergo preclinical testing and clinical trials and a regulatory clearance process implemented by the FDA under the United States Food, Drug and Cosmetic Act and its implementing regulations. Regulation of Manufacturing Process: The company and its third-party manufacturers are subject to current Good Manufacturing Practices, which are regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by the FDA and the European Medicines Agency. Health Law Compliance: In addition to FDA laws and regulations, the company must also comply with various federal and state laws pertaining to healthcare ‘fraud and abuse’ which govern, among other things, its relationships with healthcare providers, and the marketing and pricing of prescription drug products. History Incyte Corporation was founded in 1991.
incyte corp (INCY:NASDAQ GS)
Route 141 & Henry Clay Road
Wilmington, DE 19880
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