Incyte to Provide Update on Clinical Programs at Cowen Health Care Conference
A live and archived copy of the presentation will be available on Incyte's website on March 17, 2008, at 3:15 pm ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) will announce today at the Cowen and Company 28th Annual Health Care Conference results from its initial meeting with the U.S. Food & Drug Administration (FDA) regarding the development of its lead JAK inhibitor, INCB18424, for myelofibrosis.
Paul Friedman, M.D., Incyte’s President and CEO, stated, “We had a successful meeting with the FDA where we discussed the design of the registration studies of INCB18424 for myelofibrosis. We’ve reached agreement on the type of endpoints that will support approval and we will not be required to demonstrate improved survival or normalization of cell counts in the blood or bone marrow. Based on the impressive clinical results we continue to see in the ongoing Phase II trial, I firmly believe that the types of primary endpoints discussed are quite achievable. Over the next several months we will select the final dosing regimen and will work with FDA to finalize all aspects of these protocols. We continue to expect to start the registration studies in the fourth quarter of this year.”
Myelofibrosis is a serious neoplastic condition characterized by bone marrow failure, life-threatening splenic enlargement, and marked constitutional symptoms which adversely affect patients’ quality of life. There are currently no approved therapies for use in this disease.
During his presentation today, Dr. Friedman will also describe Incyte’s decision to not initiate the two six-month Phase IIb trials for its lead CCR5 antagonist, INCB9471, in treatment-experienced HIV patients. Incyte is actively seeking to out license the program.
“While we continue to believe INCB9471 has the potential to be the best-in-class CCR5 antagonist, given the rapid growth in our pipeline, it’s essential that we focus our resources on programs that have the greatest near-term value. Because development of the CCR5 antagonist is one of our more expensive, time and labor intensive programs, and is now our only HIV product, we have decided not to begin the Phase IIb trials and we are currently looking to out license the program.”
Dr. Friedman will also provide an overview of the company’s other compounds in clinical development.
Investors are welcome to listen to a live webcast of Incyte’s presentation at the Cowen 28th Annual Health Care Conference at 3:15 pm ET. The presentation can be accessed at www.incyte.com under Investor Relations, Events and Webcasts. A replay of the presentation will be available for 90 days. Investors interested in listening to the live webcast should log on before the start time in order to download any required software.
About Incyte
Incyte is a Wilmington, Delaware based drug discovery and development company focused on developing proprietary orally available drugs to treat serious unmet medical needs. We have a growing pipeline with programs in oncology, inflammation and diabetes. For additional information on Incyte visit the company’s web site at www.incyte.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the results of its meeting with the FDA regarding the development of its lead JAK inhibitor, INCB 18424, for myelofibrosis, statements regarding our ability to achieve the type of clinical endpoints the FDA will require for approval, expectations regarding long-term survival studies or normalization of cell counts in the blood or bone marrow not being necessary, and plans to begin registration trials in the fourth quarter of 2008, are all 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 subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, including risk associated with the ability to finalize dosing regimen and protocols, results of further research and development, the uncertainty of the FDA approval process, the impact of competition and of technological advances and the ability of Incyte to compete against parties with greater financial or other resources, Incyte's ability to enroll a sufficient number of patients for its clinical trials, the risks associated with Incyte's ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2007. Incyte disclaims any intent or obligation to update these forward-looking statements.