Press Release

• Results from ongoing proof-of-concept trial of PI3Kδ inhibitor INCB40093 as monotherapy and in combination with JAK1 inhibitor INCB39110 in B-cell malignancies, including Hodgkin lymphoma
• Follow-up results from pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera, showing 83% of patients were still receiving ruxolitinib at a median exposure of 111 weeks

WILMINGTON, Del.--(BUSINESS WIRE)--May 27, 2015-- Incyte Corporation (Nasdaq: INCY) today announced that 23 abstracts detailing studies from its clinical development pipeline, including those conducted by Incyte, Novartis and independent investigators, will be presented at the 2015 American Society of Clinical Oncology(ASCO) and European Hematology Association (EHA) annual meetings. These conferences will take place from May 29^th – June 2^nd (ASCO) in Chicago, IL and June 11^th – 14^th (EHA) in Vienna, Austria.

“The abstracts to be presented at ASCO and EHA showcase the depth and breadth of our development pipeline in oncology, as well as the success of our collaboration with Novartis,” stated Rich Levy, MD, Incyte’s Chief Drug Development Officer. “Incyte is committed to translating R&D excellence into new medicines which can improve patients’ lives, and these data, including novel:novel combinations from within our portfolio, provide further evidence of our ongoing progress.”

Highlighted ASCO Abstracts

B-cell malignancies

Phillips, TJ et al; Interim analysis of a Phase 1 study of INCB040093, a PI3Kδ inhibitor, alone or in combination with INCB039110, a selective JAK1 inhibitor, in patients with relapsed or refractory B-cell malignancies. Sunday, May 31, 8:00-11:30, discussion 16:30-17:45, abstract # 8520

Forero-Torres, A et al; A Phase 1 study of INCB040093, a PI3Kδ inhibitor, alone or in combination with INCB039110, a selective JAK1 inhibitor: Interim results from patients with relapsed or refractory classical Hodgkin lymphoma. Sunday, May 31, 08:00-11:30, abstract # 8558

Polycythemia vera

Verstovsek, S et al; Ruxolitinib in polycythemia vera: Follow-up from the RESPONSE trial. Sunday, May 31, 08:00-11:30, abstract # 7087

Chronic myelomonocytic leukemia

Padron, E et al; A multi-institution Phase I trial of ruxolitinib in chronic myelomonocytic leukemia. Sunday, May 31, 8:00-11:30, discussion 11:30-12:45, abstract # 7021

Highlighted EHA Abstracts

B-cell malignancies

Phillips, TJ et al; A Phase 1 study of patients with relapsed or refractory B-cell malignancies treated with a PI3Kδ inhibitor (INCB040093) alone or in combination with a selective JAK1 inhibitor (INCB039110). Friday, June 12; 17:15-18:45, abstract # P326

Forero-Torres, A et al; A Phase 1 study of patients with relapsed or refractory classical Hodgkin lymphoma treated with a PI3Kδ inhibitor (INCB040093) alone or in combination with a selective JAK1 inhibitor (INCB039110). Friday, June 12; 17:15-18:45, abstract # P333

Polycythemia vera

Kiladjian, J-J et al; Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial. Saturday, June 13; 11:45-12:00, abstract # S447

Verstovsek, S et al; Safety of ruxolitinib in patients with polycythemia vera: Results from the clinical trial program. Saturday, June 13; 17:15-18:45, abstract # P672

Verstovsek, S et al; Effect of Ruxolitinib on Markers of Iron Deficiency: An Analysis of the RESPONSE Trial. Saturday, June 13; 17:15-18:45, abstract # P673

Griesshammer, M et al; Ruxolitinib provides consistent hematocrit control in patients with polycythemia vera resistant to or intolerant of hydroxyurea. Saturday, June 13; 17:15-18:45, abstract # P670

Passamonti, F et al; Ruxolitinib vs best available therapy in patients with polycythemia vera treated in the RESPONSE study: A subgroup analysis of hydroxyurea- and non-hydroxyurea-treated patients. Friday, June 12, 09:30 to Saturday, June 13, 18:45, abstract # E1334

Harrison, CN et al; Complete hematologic control with ruxolitinib in patients with polycythemia vera resistant to or intolerant of hydroxyurea. Friday, June 12, 09:30 to Saturday, June 13, 18:45, abstract # E1353

Myelofibrosis

Daver, N et al; Ruxolitinib in combination with 5-azacytidine as therapy for patients with myelofibrosis. Saturday, June 13; 12:00-12:15, abstract # S448

Deininger, M et al; Ruxolitinib reduces JAK2617F allele burden in patients with myelofibrosis. Saturday, June 13; 17:15-18:45, abstract # P674

Pilar Giraldo, P et al; Safety and efficacy of ruxolitinib in patients with intermediate-1-risk myelofibrosis from an open-label, multicenter, single-arm expanded access study. Saturday, June 13; 17:15-18:45, abstract # P675

About Incyte

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

About ruxolitinib

Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi^® (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi^® (ruxolitinib) outside the United States.

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 during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider 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 tuberculosis (TB), or have been in close contact with someone who has TB, have or had liver or kidney problems, are on dialysis, had skin cancer 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.jakafi.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 contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the potential efficacy, safety and therapeutic value of Incyte’s pipeline compounds and the potential of such pipeline compounds and Incyte’s R&D efforts to produce new medicines and improve patients’ lives; and Incyte’s plans to present the enumerated abstract presentations at the 2015 ASCO meeting and the 2015 EHA meeting, as the case may be.

These forward-looking statements are based on the Company’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 Jakafi and the compounds in Incyte’s pipeline, the results of further research and development, the risks that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, other market or economic factors, competitive and technological advances, and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2015. The Company disclaims any intent or obligation to update these forward-looking statements.

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Source: Incyte Corporation

Incyte Corporation
Michael Booth, DPhil
Vice President, Investor Relations
302-498-5914