OVERVIEW THE DRIVE TO DISCOVER. THE EXPERIENCE TO DELIVER. October 2014
Transcription
OVERVIEW THE DRIVE TO DISCOVER. THE EXPERIENCE TO DELIVER. October 2014
THE DRIVE TO DISCOVER. THE EXPERIENCE TO DELIVER. October 2014 www.incyte.com OVERVIEW Ÿ A fully-integrated biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology Ÿ A world class team of highly experienced scientists and pharmaceutical professionals collaborating across all disciplines, backed by a solid financial position Ÿ An approach that is marked by rigorous science, effective teamwork, disciplined program execution and an unwavering commitment to patients Ÿ An FDA-approved product, Jakafi® (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), and a rich portfolio of novel compounds under development Ÿ An experienced U.S. commercial organization, plus strategic collaborations with top-tier pharmaceutical companies to deliver its novel therapeutics worldwide “The field of oncology is evolving at an unprecedented pace, and Incyte has a central position in the ongoing transformation in how cancer patients are treated.” Hervé Hoppenot Incyte President and Chief Executive Officer ADVANCED PIPELINE Incyte has an broad pipeline of product candidates, primarily focused on oncology. Compound Jakafi® (ruxolitinib) Target JAK1 / JAK2 Indication Proof of Concept Trials Pivotal Trials Myelofibrosis a Polycythemia vera a Pancreatic cancer b Advanced malignancies b Non-small cell lung cancer b Breast cancer b Colorectal cancer b INCB39110 JAK1 Advanced malignancies INCB24360 IDO1 Metastatic melanoma Non-small cell lung cancer Incyte Corporation Quick Facts Non-small cell lung cancer c Non-small cell lung cancer * d Established in 1991 Approximately 600 employees IPO in 1993 NASDAQ symbol: INCY Multiple cancers * e Multiple cancers * f INCB40093 PI3Kδ B-lymphoid malignancies INCB40093+INCB39110 PI3Kδ + JAK1 B-lymphoid malignancies INC280 g Hepatocellular carcinoma c-MET Non-small cell lung cancer Solid tumors Baricitinib h Incyte Corporation 1801 Augustine Cut-Off Wilmington, DE 19803 www.incyte.com 855.4.INCYTE (855.466.2983) JAK1 / JAK2 Rheumatoid arthritis Psoriasis Diabetic nephropathy a Incyte: U.S. rights; Novartis: ex-U.S. rights b Incyte: U.S. rights c In combination with Merck’s MK-3475 d In combination with Genentech’s MPDL3280A e In combination with MedImmune’s MEDI4736 f In combination with Bristol-Myers Squibb’s nivolumab g Novartis: worldwide rights h Lilly: worldwide rights * Trial not yet initiated Marketed A PATHWAY TO GROWTH ® Jakafi (ruxolitinib) is approved in the United States for the treatment of intermediate or high-risk myelofibrosis (MF), a myeloproliferative neoplasm and a type of rare blood cancer. Jakafi is an oral treatment that inhibits the Janus kinases JAK1 and JAK2, resulting in the down-modulation of overactive JAK signaling. Over-active or dysregulated JAK1 and JAK2 has been linked to the enlarged spleens and debilitating symptoms seen in the majority of patients with MF. Ruxolitinib recently met the primary endpoint in the pivotal Phase III RESPONSE study of patients with polycythemia vera (PV), a second myeloproliferative neoplasm and for which ruxolitinib use is investigational and not approved. Ruxolitinib is also in clinical development for the treatment of patients with other types of cancer, including pancreatic, lung, breast and colorectal cancers. “During clinical trials, Jakafi provided significant reductions in spleen size and significant improvements in symptoms in patients with myelofibrosis.” Srdan Verstovsek, M.D., Ph.D. MD Anderson Cancer Center, Houston, Texas INDICATIONS AND USAGE Jakafi is indicated for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis. IMPORTANT SAFETY INFORMATION Jakafi can cause serious side effects including: Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever. Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters. The most common side effects of Jakafi include dizziness and headache. These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away. Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had liver or kidney problems, are on dialysis, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi. Contact Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding. Please see the Full Prescribing Information available at www.jakafi.com, which includes a more complete discussion of the risks associated with Jakafi. www.incyte.com Incyte and Jakafi are registered trademarks of Incyte Corporation. © Copyright 2010 - 2014 Incyte Corporation. All rights reserved. | www.jakafi.com REV 10 13 2014 Pamela M. Murphy VP, Investor Relations and Corporate Communications 855.4.INCYTE (855.466.2983) [email protected]