CHAPEL HILL, NC – November 22, 1999 – POZEN Inc. today announced that the company has acquired an exclusive worldwide license to a novel serotonin (5-HT2B) receptor antagonist discovered by F. Hoffmann-La Roche, Ltd. The compound, now known as MT 500, will be the first drug developed specifically as a migraine prophylactic agent. Under the terms of the agreement, POZEN Inc. has assumed full responsibility for development, regulatory approval, and commercialization throughout the world and agreed to pay Roche certain consideration upon commercialization of the product by POZEN Inc. or a third party. At its option, Roche may reacquire and commercialize the product at pre-agreed times subject to the payment of certain milestones and royalties to POZEN Inc.
The Roche Bioscience unit of F. Hoffmann-La Roche has completed Phase I trials on MT 500, indicating a favorable side effect and safety profile. The results of these early studies suggest that MT 500 is a promising agent for full development as a preventative migraine therapy. Use of such therapies has been limited by side effects and lack of efficacy. POZEN Inc. expects to commence Phase II studies during the first half of 2000.
Over 23 million Americans suffer from migraine, which causes debilitating headache pain, nausea, and extreme sensitivity to light and sound. Current therapies, which focus on the acute treatment of migraine symptoms, accounted for more than $1 billion in 1998 sales in the U.S.
“This agreement with one of the world's leading pharmaceutical companies validates our license-back strategy,” said Dr. John Plachetka, president and CEO of POZEN Inc. “Since our staff has broad therapeutic experience, we intend to continue to acquire and develop commercially attractive, lower risk pharmaceutical products for other disease states.”
POZEN Inc. is a late-stage private company that utilizes its broad-based, commercially focused, drug development expertise to acquire and bring to market late pre-clinical or clinical stage products more efficiently and with less risk as compared to traditional methods. POZEN Inc.'s initial focus is in the area of migraine therapeutics, where the Company has several products in clinical development, including one in Phase III. POZEN Inc. plans to commercialize its products through partnerships with pharmaceutical companies while retaining certain marketing and manufacturing rights.
This release contains forward-looking statements based on current expectations of the company's management. Such statements are subject to risks and uncertainties which could cause actual results to differ from those projected, including risk and uncertainties related to the conduct of, and results obtained from, clinical trials; the timing and scope of the approvals received from regulatory agencies; the company's dependence on strategic alliances; competition; and technological change.