Incyte Corporation, a biopharmaceutical company, focuses on the discovery, development and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. Marketed Indications - JAKAFI (ruxolitinib) JAKAFI (ruxolitinib) is the company’s first product to be approved for sale in the United States. It was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of patients with intermediate or high-risk myelofibrosis (MF) and in 2014 for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. JAKAFI is marketed in the United States through the company’s own specialty sales force and commercial team. To help ensure that all eligible MF and PV 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 or uncontrolled PV 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 with payers to help facilitate insurance coverage of JAKAFI. JAKAFI is distributed primarily through a network of specialty pharmacy providers and wholesalers that allow for the delivery of the medication by mail directly to patients or direct delivery to the patient's pharmacy. The company’s distribution process uses a model that is familiar to physicians who practice within the oncology field. Clinical Programs JAK1/JAK2 Programs for Inflammation Alopecia Areata: In October 2015, the company initiated a Phase II trial of ruxolitinib cream for the topical treatment of alopecia areata. This new study builds on published data showing efficacy of oral JAK inhibitors, including ruxolitinib, in alopecia areata. Rheumatoid Arthritis: The company has a second JAK1 and JAK2 inhibitor, baricitinib, which is subject to its collaboration agreement with Eli Lilly and Company (Lilly), in which Lilly received exclusive worldwide development and commercialization rights to the compound for inflammatory and autoimmune diseases. The Phase III program of baricitinib in patients with rheumatoid arthritis incorporated all three rheumatoid arthritis populations (methotrexate naïve, biologic naïve, and biologic experienced); used event rates to fully power the baricitinib program for structural comparison and non-inferiority vs. adalimumab; incorporated an MRI sub study into the methotrexate naïve registration trial; and evaluated patient-reported outcomes. All four Phase III trials met their respective primary endpoints. In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency for baricitinib as treatment for mild-to-moderately severe rheumatoid arthritis. Psoriasis: Baricitinib has completed a Phase II trial as a treatment for psoriasis. Diabetic Nephropathy: In August 2012, Lilly initiated a Phase IIa trial to evaluate baricitinib in patients with diabetic nephropathy. Data suggests that ongoing renal inflammation plays a key role in diabetic nephropathy, and biopsies from the kidneys of early- and late-stage diabetic kidney disease patients suggest that over-activation of the JAK/STAT pathway leads to increased levels of pro-inflammatory cytokines. Therefore, inhibiting cytokine pathways dependent on JAK1 and JAK2 might lead to positive clinical outcomes in diabetic nephropathy. This dose-ranging placebo-controlled Phase IIa trial met its primary endpoint of a change from baseline in the urinary albumin/creatinine ratio at 24 weeks. The company retains co-development and co-promotion options for this indication. Atopic Dermatitis: In October 2015, Lilly initiated a Phase IIa trial to evaluate the safety and efficacy of baricitinib in patients with moderate-to-severe atopic dermatitis. JAK1 Programs for Oncology and Autoimmune D
(INCY:Consolidated Issue Listed on NASDAQ Global Select )
1801 Augustine Cut-Off
Wilmington, DE 19803
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