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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (636)	2/20/2002 8:43:47 PM
From: tuck	Read Replies (1) \| Respond to of 1005

>>Chapel Hill, N.C., Feb. 20 /PRNewswire-FirstCall/ -- POZEN Inc. (Nasdaq: POZN - news), a pharmaceutical development company with a portfolio of candidates for the treatment of migraine, announced today that the Food and Drug Administration (FDA) has agreed to accept results from the company's ongoing rat carcinogenicity study during the New Drug Application (NDA) review period for MT 100, the company's lead product candidate. POZEN also confirmed that FDA approval of the MT 100 NDA is still dependent on the successful completion and review of two carcinogenicity studies. Preliminary results of the first carcinogenicity study were submitted to the FDA earlier this month and the final report will be submitted in the next few weeks. Those preliminary results indicated that MT 100 was not carcinogenic in the test species, p53 transgenic mice. The in-life portion of the second study, an ongoing, two-year rat carcinogenicity study, will be complete in August 2003, with submission of the results to the FDA as soon as possible thereafter. Based on the company's latest discussions with the FDA, POZEN plans to submit its NDA for MT 100 in the first half of 2003. MT 100 is being developed as an oral, first-line treatment for migraine pain and associated symptoms. The effectiveness of the product candidate has been demonstrated in numerous Phase II and Phase III clinical studies involving thousands of patients. Last year the company announced that MT 100 provided comparable efficacy with fewer side effects when tested against Imitrex®, the worldwide market leader. North Carolina-based POZEN Inc. is a pharmaceutical development company committed to building a portfolio of products with significant commercial potential in select therapeutic areas. POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.6 billion this year. The company's common stock is traded on The Nasdaq Stock Market under the symbol ``POZN.''<< snipped the safe harbor boilerplate Cheers, Tuck