|POZEN Announces Favorable Results of Rat Carcinogenicity Study for MT 100 and Submission of Study Report to FDA|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jan. 28, 2004--POZEN Inc. (Nasdaq:POZN) announced today that the results of a two-year rat carcinogenicity study provided no evidence that the concomitant administration of maximum tolerated doses of metoclopramide and naproxen, the two active components in MT 100, produced any statistically significant differences in findings from those seen with metoclopramide alone. None of the tumors observed in the study were considered to be directly related to the administration of metoclopramide or naproxen; all were considered to be secondary to metoclopramide-induced increases in the levels of the hormone prolactin in the affected rats.
The study report was submitted yesterday to the U.S. Food and Drug Administration (FDA) and completes the MT 100 New Drug Application submission made by POZEN in July 2003, which was accepted for filing by the FDA in October 2003 and is currently in review. MT 100 is being developed as an oral first-line therapy for the acute treatment of migraine.
The study evaluated the occurrence of tumors among six groups of male and female Wistar han rats that received daily oral doses of metoclopramide and/or naproxen. One group received metoclopramide alone at its maximum tolerated dose (MTD). Another group received naproxen alone at its MTD. Three groups received naproxen at its MTD combined with metoclopramide at either a low or medium dose or at its MTD. A control group received placebo.
The data showed that there were no statistically significant differences in findings between the rats that received the MTD of metoclopramide in combination with naproxen and the rats that received metoclopramide alone at its MTD.
The study results are consistent with previous findings reported in rodents with chronically increased prolactin levels. As expected, metoclopramide, alone and in combination with naproxen, produced significant increases in serum prolactin levels compared to the control group, an effect thought to be due to the pharmacologic action of metoclopramide as a dopamine antagonist. Also as expected, increases in rates of prolactin-mediated tumors occurred in prolactin sensitive endocrine glands in rats that received metoclopramide, alone and in combination with naproxen, compared to the control group. Examples of drugs marketed in the U.S. that elevate prolactin hormone levels in rodents include aripiprazole, risperidone, ziprasidone, olanzapine, pimozide, and quetiapine.
The data also showed no evidence that naproxen augmented the demonstrated endocrine effects of metoclopramide in the combination. There were also no statistically significant differences in findings between the rats that received naproxen alone and the rats in the control group, confirming results of previous studies with this drug in which there was no evidence of carcinogenicity. Metoclopramide and naproxen are commercially available drugs and have been on the market for more than 20 years.
"We are very pleased with the outcome of the study and we are grateful to the FDA for allowing us to submit these data during the NDA review process without affecting the date by which the FDA should complete its review of the NDA, May 31, 2004," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN.
POZEN previously completed a six-month oral carcinogenicity study in p53 transgenic mice and submitted the report to the FDA in early 2002. The results of that study indicated that MT 100 was not carcinogenic in the p53 transgenic mouse model.
MT 100 Clinical Trials
The clinical trials conducted by POZEN have consistently provided evidence of the safety and effectiveness of MT 100. Over 8,000 patients with migraine participated in Phase III trials in which MT 100 has been shown to provide significant benefits compared to placebo for the relief of pain and the associated symptoms of migraine including nausea, sensitivity to light and sensitivity to sound. Importantly, in two Phase III trials in which MT 100 was compared to Imitrex(R) 50mg, the market-leading drug for the treatment of migraine, MT 100 demonstrated comparable efficacy and a lower percentage of patients reporting adverse events. Because of its overall efficacy and safety profile, POZEN believes MT 100, if approved by the FDA, should become the drug of choice as first-line prescription therapy for most migraine attacks.
POZEN to Host Webcast Today at 8:30 a.m. Eastern Time
POZEN management will host a webcast at 8:30 a.m. Eastern time on Wednesday, January 28, 2004, to discuss the information in this release. The webcast will be live and archived on POZEN's home page at www.pozen.com.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel Pharmaceuticals, and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results resulting in, among other things, our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2003 under "Management's Discussion and Analysis of Financial Condition and Results of Operations." We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.