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Incyte Reports 2012 Third-Quarter Financial Results; Updates Shareholders On Launch Of Jakafi And Lead Clinical Programs

Stock quotes in this article: INCY

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 401502.

The conference call will also be webcast live and can be accessed at www.incyte.com under Investor Relations – Events and Webcasts.

About Incyte

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

About Jakafi

Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.

Important Safety Information

  • Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
  • Patients with platelet counts <200 × 10 9/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered
  • Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered
  • Neutropenia (ANC <0.5 × 10 9/L) was generally reversible and was managed by temporarily withholding Jakafi
  • Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly
  • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy
  • There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus
  • Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

For Full Prescribing Information for Jakafi, visit www.Jakafi.com.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements regarding our plans and expectations with respect to Jakafi (ruxolitinib), including the potential efficacy and therapeutic and commercial value of Jakafi, our expectation regarding continued steady, consistent growth, our expectation that results from the RESPONSE and RELIEF trials are expected to be part of a sNDA submission in 2014, our expectation that the RECAP trial will enroll approximately 130 patients by late 2012 with final results expected in the second half of 2013, our expectation that results from the trials conducted by our collaboration partner Eli Lilly and Company evaluating baricitinib in patients with moderate to severe psoriasis and diabetic nephropathy will be available in 2013 and 2014, respectively, our expectation that the initial Phase I trial evaluating INCB28060 is nearing completion, updated financial guidance about expected net product revenues, and expectations regarding variations in research and development expenses, contain predictions, estimates and other forward-looking statements.

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