Multiple Data Presentations at the 2014 American Society of Hematology (ASH) Annual Meeting Showcase Incyte's Leadership in the Field of Myeloproliferative Neoplasms (MPNs)

Incyte Corporation (Nasdaq: INCY) today announced that over 40 abstracts, detailing studies conducted by Incyte, Novartis and multiple independent investigators in patients with myeloproliferative neoplasms (MPNs), will be presented at the 50th Annual Meeting of the American Society of Hematology (ASH), which is to be held from December 6-9, 2014 in San Francisco.

“Polycythemia vera and myelofibrosis are rare and progressive blood cancers that can be debilitating and life-threatening. The depth and breadth of the data presentations at ASH further support the potential of ruxolitinib as a treatment for patients with these MPNs, as well as confirming Incyte’s leadership in the field and our commitment to improving the lives of these patients,” stated Hervé Hoppenot, President and CEO of Incyte.

Polycythemia Vera

Analyses of the RESPONSE trial provide additional insight into the efficacy of ruxolitinib in patients with PV resistant to or intolerant of hydroxyurea.

Vannucchi AM, et al. Efficacy of Ruxolitinib by Baseline Spleen Volume in Patients With Polycythemia Vera Resistant to or Intolerant of Hydroxyurea Abstract # 1840; December 6, 2014: 5:30pm - 7:30pm PST

Kiladjian JJ, et al. Clinical Benefit of Ruxolitinib Treatment After Crossover From Best Available Therapy in Patients With Polycythemia Vera: Analysis of the RESPONSE Trial Abstract # 3181; December 7, 2014: 6:00pm - 8:00pm PST

Verstovsek S, et al. Ruxolitinib Efficacy by Hematocrit Control in Patients with Polycythemia Vera: An Analysis of the RESPONSE Trial Abstract # 3201; December 7, 2014: 6:00pm - 8:00pm PST

Mesa R, et al. Changes in Quality of Life and Disease-Related Symptoms in Patients With Polycythemia Vera Receiving Ruxolitinib or Best Available Therapy: RESPONSE Trial Results Abstract # 709; December 8, 2014: 6:15pm PST

In a retrospective chart review of patients with PV in the U.S., approximately two thirds of patients receiving hydroxyurea had elevated hematocrit, platelet counts, or white blood cell counts.

Parasuraman S, et al. Treatment Patterns and Hydroxyurea Response Among Patients with Polycythemia Vera Abstract # 1852; December 6, 2014: 5:30pm - 7:30pm PST

Other studies in PV to be presented include:

Mesa R, et al. The Efficacy and Safety of Continued Hydroxyurea Therapy Versus Switching to Ruxolitinib in Patients with Polycythemia Vera: A Randomized, Double-Blind, Double-Dummy, Symptom Study (RELIEF) Abstract # 3168; December 7, 2014: 6:00pm - 8:00pm PST

Goyal RK, et al. Increased Incidence of Thromboembolic Event Rates in Patients Diagnosed with Polycythemia Vera: Results from an Observational Cohort Study Abstract # 4840; December 8, 2014: 6:00pm - 8:00pm PST

Myelofibrosis

Data to be presented includes updates from EXPAND (a trial in patients with low platelet counts) and JUMP (an expanded access study in over 1,000 patients) that illustrate the efficacy of ruxolitinib in patients with low platelet counts as well as intermediate-1, intermediate-2, and high-risk MF. Additional analyses from the COMFORT-II study confirmed that patients with mutations in CALR showed a similar response and tolerability profile with ruxolitinib treatment compared to the overall COMFORT-II study population.

te Boekherst P, et al. A Phase 1b, Open-Label, Dose-Finding Study of Ruxolitinib in Patients with Myelofibrosis (MF) and Baseline Platelet Counts From 50×109/L to 99×109/L (The EXPAND Study) Abstract # 1841; December 6, 2014: 5:30pm - 7:30pm PST

Griesshammer M, et al. Safety and Efficacy of Ruxolitinib in Patients With Low Platelets Enrolled in a Phase 3b Expanded-Access Study in Myelofibrosis (MF) Abstract # 1859; December 6, 2014: 5:30pm - 7:30pm PST

Martino B, et al. Safety and Efficacy of Ruxolitinib in an Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients With Myelofibrosis (MF): an 1144-Patient Update Abstract # 3197; December 7, 2014: 6:00pm - 8:00pm PST

Guglielmelli P, et al. A Retrospective Analysis of Safety and Efficacy of Ruxolitinib in CALR-positive Patients with Myelofibrosis Abstract # 1853; December 6, 2014: 5:30pm - 7:30pm PST

Results from a retrospective chart review of 108 patients in the U.S. with low and intermediate-1 risk MF suggest that lower-risk patients treated with ruxolitinib experience meaningful improvements in spleen size and symptoms.

Davis KL, et al. Real-World Assessment of Clinical Outcomes in Lower-Risk Myelofibrosis Patients Receiving Treatment with Ruxolitinib Abstract # 1857; December 6, 2014: 5:30pm - 7:30pm PST

Ruxolitinib continues to be investigated in combination with other therapies in development. Results from three of these trials will be part of an oral session.

Durrant P, et al. HARMONY: An Open-Label, Multicenter, 2-Arm, Dose-Finding, Phase 1b Study of the Combination of Ruxolitinib and Buparlisib (BKM120) in Patients With Myelofibrosis (MF) Abstract # 710; December 8, 2014: 6:30 PM PST

Kiladjian JJ, et al. Efficacy, Safety, and Confirmation of the Recommended Phase 2 Dose of Ruxolitinib Plus Panobinostat in Patients with Intermediate or High-Risk Myelofibrosis Abstract # 711; December 8, 2014: 6:45pm PST

Gupta V, et al. Phase 1b Dose-Escalation Study of Sonidegib (LDE225) in Combination With Ruxolitinib (INC424) in Patients With Myelofibrosis Abstract # 712; December 8, 2014: 7:00pm PST

Other data in MF to be presented include:

Mascarenhas et al. Primary Analysis Results from an Open-Label Phase II Study of INCB039110, a Selective JAK1 Inhibitor, in Patients with Myelofibrosis Abstract # 714; December 8, 2014: 7:30pm PST

The MPN LANDMARK Survey

LANDMARK, the first-ever survey of its kind, and including over 800 patients with MPNs and 450 physicians who treat these disorders, was conducted to evaluate the burden and impact of MPNs from both the patient and physician perspective. According to the survey findings, in addition to a profound symptom burden, patients with MF, PV, and ET also experience a significant loss of productivity and diminished daily activities as a result of their condition. The findings also highlighted the importance of clear communication between physicians and their patients.

Mesa R, et al. Impact of Myeloproliferative Neoplasms (MPNs) on Patients’ Overall Health and Productivity: Results from the MPN Landmark Survey in the United States Abstract # 3183; December 7, 2014: 6:00pm - 8:00pm PST

Mesa R, et al. Gaps in Perception Between Patients and Physicians Regarding Symptomatology and Treatment Attitudes for Myeloproliferative Neoplasms: MPN Landmark Survey Abstract # 4827; December 8, 2014: 6:00pm - 8:00pm PST

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

About Ruxolitinib

Ruxolitinib is an oral, selective inhibitor of Janus kinases 1 and 2 (JAK1 and JAK2). In the United States, ruxolitinib, brand name Jakafi®, is indicated for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Under the terms of the 2009 Incyte and Novartis worldwide collaboration and license agreement, Novartis received exclusive rights to the development and potential commercialization of ruxolitinib in all hematology-oncology indications outside of the U.S.

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.

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.incyte.com, which includes a more complete discussion of the risks associated with Jakafi.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the potential efficacy, safety and therapeutic value of ruxolitinib in polycythemia vera and myelofibrosis, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the efficacy or safety of ruxolitinib, the results of further research and development, other market or economic factors, competitive and technological advances, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Incyte disclaims any intent or obligation to update these forward-looking statements.