Incyte Presents Significant Progress In Its Development Portfolio

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today reported significant and rapid progress in its continued transformation into a leading global biopharmaceutical company. With two new programs expected to enter the clinic in the coming months, Incyte will have 13 development molecules in pivotal and proof-of-concept trials across a variety of oncology and non-oncology indications, illustrating the power of Incyte’s drug discovery and development engine.

“We are experiencing a revolution in the way cancer is treated, and Incyte is at the forefront of innovation in drug discovery”

“We are experiencing a revolution in the way cancer is treated, and Incyte is at the forefront of innovation in drug discovery,” said Hervé Hoppenot, President and Chief Executive Officer, Incyte. “Our rich portfolio of small molecules and biologics places us in a unique position. We have significant optionality to investigate these candidates alone as well as in combination as we continue our mission to deliver medicines that will positively impact the lives of patients with cancer and other diseases.”

Presentation Highlights

JAK Inhibitors

The Phase 3 JANUS 1 trial of ruxolitinib, a JAK1 / JAK2 inhibitor, in second line metastatic pancreatic cancer is now fully recruited, with results expected in 2016. The primary endpoint of JANUS 1 is overall survival. Two Phase 2 trials of ruxolitinib, in colorectal and breast cancer, are now fully recruited, with overall survival data expected from both in 2016.

Incyte has two selective JAK1 inhibitors in clinical development, INCB39110 and INCB52793. A clinical collaboration has been initiated to investigate the safety and efficacy of the combination of INCB39110 with AstraZeneca’s next generation EGFR inhibitor Tagrisso^® (osimertinib)* in patients with EGFRm non-small cell lung cancer with the T790M mutation. Incyte’s second JAK1 selective inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.

Building upon positive, published third-party data of ruxolitinib from an investigator-sponsored trial in graft versus host disease (GVHD), a proof-of-concept trial of INCB39110 for the treatment of patients with GVHD has begun.

Each of the four pivotal trials of baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Eli Lilly and Company, met the primary endpoint in patients with rheumatoid arthritis. Lilly is finalizing the submissions of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency. Both will trigger milestone payments from Lilly to Incyte.

IDO1 Inhibitor

The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.

The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody Keytruda^® (pembrolizumab)* for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016. Recruitment has also begun into the eight tumor-specific cohorts of ECHO-202, the Phase 2 trial of epacadostat in combination with pembrolizumab.

Incyte is conducting three additional Phase 1/2 clinical trials of epacadostat in combination with immune checkpoint inhibitors. ECHO-204, in combination with Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo^® (nivolumab)*, has opened seven tumor specific cohorts, and ECHO-203 with AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, durvalumab, has opened six tumor specific cohorts. ECHO-110, a trial in combination with Roche/Genentech’s investigational PD-L1 inhibitor, atezolizumab, in patients with NSCLC is ongoing.

Selected Portfolio Updates

Incyte’s PI3Kd inhibitor clinical development program is focused on INCB50465, based on the molecule’s potential lack of hepatotoxicity and improved potency compared to approved PI3Kd inhibitors and compared to Incyte’s PI3Kd inhibitor INCB40093. A Phase 1/2 trial of INCB50465, both as monotherapy and in combination with INCB39110, is already underway in multiple B-cell malignancies. Clinical activities of INCB40093 are being closed.

Incyte is also pursuing a series of clinical studies to investigate the safety and efficacy of several therapeutic doublets. These include a clinical trial of Incyte’s JAK1 inhibitor, INCB39110, in combination with either its IDO1 inhibitor, epacadostat, or its PI3Kd inhibitor, INCB50465, as well as a trial of Merck’s anti-PD-1 antibody, pembrolizumab, in combination with either Incyte’s PI3Kd inhibitor, INCB50465, or its JAK1 inhibitor, INCB39110.

Two new compounds are expected to enter Incyte’s clinical development portfolio in the first half of 2016. INCB59872, a potent and selective LSD1 inhibitor, is expected to enter clinical trials in patients with advanced malignancies in the coming months. INCAGN1876, an anti-GITR agonist antibody that is part of the ongoing discovery alliance with Agenus, Inc, is expected to enter clinical trials for the treatment of patients with advanced cancer during the first half of 2016. Incyte’s alliance with Agenus has recently been expanded to include a total of 7 therapeutic targets, with options for additional expansion.

Corporate Update

In January 2016, Michael Morrisey joined Incyte Europe Sàrl and the Incyte Executive Management team as Corporate Senior Vice President and Head of Global Technical Operations. Michael has extensive manufacturing experience and has excelled in building manufacturing organizations, most recently as Corporate Vice President, Head of International Technical Operations at Celgene International.

Webcast Information

A presentation made by Incyte at the 34^th Annual J.P. Morgan Healthcare Conference will be webcast live today at 1:30pm PT / 4:30pm ET and can be accessed within the Investors section of www.incyte.com under Events and Presentations. Investors interested in listening to the live webcast should log on before the start time in order to download any software required. The slide deck and a replay of the presentation will also be made available following the presentation.

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 Jakafi^® (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration 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.

Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

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 Company’s continued transformation into a world-leading biopharmaceutical business; the Company’s advancing development pipeline and the design, efficacy, safety, timing and potential success of any of those studies as well as the Company’s and, where applicable, its and its collaborators’ plans to announce data from any of those studies; and whether and when the Company’s collaborator, Lilly, will file an NDA or an MAA for baricitinib and whether and when the Company will receive certain milestone payments related thereto.

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 any of the product candidates in the Company’s development portfolio, , the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, the risks that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, the ability to enroll sufficient numbers of subjects in clinical trials, other market, economic or strategic factors and technological advances, unanticipated delays, the ability of the Company to compete against parties with greater financial or other resources, risks associated with the Company’s dependence on its relationships with its collaboration partners, 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 September 30, 2015. The Company disclaims any intent or obligation to update these forward-looking statements.

* The brand listed is not a trademark of Incyte Corporation. The maker of this brand is not affiliated with and does not endorse Incyte Corporation or its products.