Incyte Corporation, a biopharmaceutical company, focuses on the discovery, development and commercialization of proprietary small molecule drugs to treat serious unmet medical needs. JAKAFI JAKAFI became commercially available in the United States in 2011 and is being marketed in the United States through its own specialty sales force and its commercial team, which has relevant expertise in the promotion, distribution and reimbursement of oncology drugs. 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 treatment. In addition, IncyteCARES works closely with payers to help facilitate insurance coverage of JAKAFI. JAKAFI is distributed primarily through a limited network of specialty pharmacy providers and group purchasing organizations that allow for delivery of the medication by mail directly to patients or direct delivery to the patient's pharmacy of choice. Novartis received approval for JAKAVI in the European Union and Canada in 2012. JAKAVI is approved in approximately 50 countries with additional worldwide regulatory filings underway. 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 and other oncology indications. Research and Development As of December 31, 2013, the company incurred research and development expenses of $260.4 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. 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. Significant Events Bristol-Myers Squibb Company and Incyte Corporation announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in a Phase I/II study. History Incyte Corporation was founded in 1991.
(INCY:Consolidated Issue Listed on NASDAQ Global Select )
1801 Augustine Cut-Off
Wilmington, DE 19803
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