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Incyte Achieves $25 Million Milestone For Approval Of Jakavi® (ruxolitinib) In Japan

Stocks in this article: INCY

Incyte Corporation (Nasdaq: INCY) announced today that it has earned a $25 million milestone payment from Novartis in connection with the approval of Jakavi ® (ruxolitinib) in Japan for the treatment of patients with myelofibrosis. Incyte will record this amount as contract revenue in the third quarter. Under the Incyte-Novartis Collaboration and License Agreement, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi ® (ruxolitinib).

“We are very pleased with the progress that Novartis is making in the global roll-out of Jakavi,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “The recent approval of Jakavi in Japan is further evidence of that progress.”

Novartis also continues to make progress in obtaining formal pricing and reimbursement approval for a third major European country and expects this to occur in the second half of 2014. Once achieved, Incyte will earn an additional $60 million milestone payment.

About Jakafi ® (ruxolitinib)

Jakafi is a prescription medicine approved by the U.S. Food and Drug Administration to treat 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 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.

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