FDA Accepts NDA Filing for Ruxolitinib as a Treatment for Myelofibrosis

Application Granted Priority Review

WILMINGTON, Del., Aug 03, 2011 (BUSINESS WIRE) -- --PDUFA Date Set for December 3, 2011

Incyte Corporation /quotes/zigman/55297/quotes/nls/incy INCY -2.03% announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte's lead investigational compound, ruxolitinib (INCB18424/INC424), as a potential treatment for patients with myelofibrosis (MF). MF is a potentially life-threatening blood cancer with limited treatment options and no FDA-approved medicines. The FDA also has granted Incyte's request for Priority Review, which is given to investigational drugs that may offer either a major advance in treatment or provide a treatment where no adequate therapy exists. The FDA has a goal to complete the Priority Review within six months. Therefore, if the application is approved, Incyte anticipates that ruxolitinib could be available for US patients with MF in the fourth quarter of 2011.

The NDA includes results from two Phase III trials, COMFORT-I conducted by Incyte and COMFORT-II conducted by Novartis, under the Incyte-Novartis worldwide collaboration and license agreement. Results from both studies were recently presented at the 2011 American Society of Clinical Oncology annual meeting and the 16th Congress of the European Hematology Association.

About Myelofibrosis (MF)

Myelofibrosis is a potentially life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms, such as fatigue, pruritus (severe itching), fever, night sweats, weight loss, bone pain and early satiety. MF is one of the Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), which also include polycythemia vera and essential thrombocythemia. Increased aberrant activation of the Janus kinase (JAK) pathway, which regulates blood cell production, has been associated with the development of the MPNs, including MF.(1)

About Ruxolitinib

Ruxolitinib, Incyte's lead JAK1 and JAK2 inhibitor, entered clinical testing in May 2007 and has shown clinical activity in a number of hematologic conditions. In addition to the recently completed Phase III studies in MF, ruxolitinib is currently being evaluated in a global Phase III registration study, RESPONSE, in patients with advanced polycythemia vera. This study is being conducted by Incyte in the US and Novartis outside of the US. Ruxolitinib is also being investigated in Phase II studies in patients with other hematologic malignancies and solid tumors.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, visit the Company's web site at www.incyte.com .