Press release from Business Wire
Incyte Achieves $25 Million Milestone for Approval of Jakavi® (ruxolitinib) in Japan
Tuesday, July 08, 2014
Incyte Achieves $25 Million Milestone for Approval of Jakavi® (ruxolitinib) in Japan07:33 EDT Tuesday, July 08, 2014
WILMINGTON, Del. (Business Wire) -- 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.
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. Do not drink grapefruit juice while taking 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.
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.
Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to Novartis continuing to make progress in obtaining formal pricing and reimbursement approval for Jakavi® (ruxolitinib) in a third major European country and expecting this to occur in the second half of 2014, and Incyte earning an additional $60 million milestone payment once achieved, 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 high degree of risk and uncertainty associated with regulatory approval processes, risks associated with Incyte's dependence on its relationships with its collaboration partners, 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 March 31, 2014. Incyte disclaims any intent or obligation to update these forward-looking statements.
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications