|POZEN and Xcel Pharmaceuticals Announce Licensing Agreement to Commercialize Injectable Migraine Treatment MT 300|
CHAPEL HILL, N.C. & SAN DIEGO--(BUSINESS WIRE)--Sept. 4, 2003--POZEN Inc. (NASDAQ: POZN) and Xcel Pharmaceuticals, Inc. (Xcel) announced today that they have signed an agreement for the commercialization of MT 300(TM) that may provide a new and effective injectable treatment for patients suffering from severe migraine headaches. MT 300 is being developed as an improved and highly purified formulation of dihydroergotamine mesylate (DHE) in a convenient pre-filled syringe that is suitable for at-home use. As previously announced, POZEN submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of MT 300 on December 17, 2002. The application is currently under review at the FDA.
Under the terms of the agreement, Xcel will have exclusive rights in the United States to commercialize MT 300. Xcel will pay POZEN an upfront fee of $2 million and potential milestone payments of up to $8 million due upon certain future regulatory approvals and the achievement of a predetermined sales threshold on MT 300. Xcel will also pay POZEN royalties on combined sales of MT 300 and Xcel's D.H.E. 45(R) (dihydroergotamine mesylate) Injection, once MT 300 is commercialized. Xcel markets and sells D.H.E. 45, which is packaged in glass ampoules and has been a standard of care for many years for the acute treatment of migraine. Royalty rates on the combined annual net sales of MT 300 and D.H.E. 45 will commence in the low double-digits and increase based on the achievement of predetermined net sales thresholds.
John R. Plachetka, Pharm.D., POZEN's Chairman, President, and Chief Executive Officer said, "We believe MT 300 is a major step forward in providing migraine sufferers with a convenient injectable product and an improved formulation of DHE. Xcel's strong focus in migraine and dedicated neurology sales force make them the partner of choice to maximize the potential of MT 300. In addition, we created an innovative agreement, where we will receive royalties on the combined sales of MT 300 and D.H.E. 45, making it a win-win situation for both parties."
In two Phase III trials involving over 1,200 migraine patients, MT 300 has consistently demonstrated its effectiveness in treating migraine pain. Data from each of the trials show a statistically significant improvement in the percentage of patients achieving pain relief at two hours as well as sustained pain relief when compared to placebo. Sustained pain relief is defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.
Michael T. Borer, Xcel's President and Chief Executive Officer said, "We are very pleased to have been selected as POZEN's commercial partner for MT 300. The addition of MT 300 significantly enhances our existing migraine franchise, consisting of Migranal(R) (dihydroergotamine mesylate) Nasal Spray and D.H.E. 45, and leverages our existing commercial infrastructure. Upon approval, MT 300 will represent a third, important, proprietary growth product in our portfolio. We plan to provide significant promotional effort for MT 300 with our 96-person field sales organization."
According to the National Headache Foundation, there are approximately 28 million people in the United States who suffer from migraine headaches of which approximately 4 million do not experience effective relief from first-line therapies, such as the oral triptan class of drugs, and are prime candidates for DHE. According to IMS Health's Retail and Provider Perspective, the injectable migraine market represented approximately $214 million in 2002 U.S. sales.
Live Webcast, Today at 9:00 a.m. Eastern Time - POZEN to Present at the NewsMakers in the Biotech Industry Conference and Discuss MT 300 Licensing Agreement
John R. Plachetka, Pharm.D., POZEN's Chairman, President, and Chief Executive Officer will present today at the NewsMakers in the Biotech Industry Conference at 9:00 a.m. Eastern Time and discuss the MT 300 licensing agreement. The presentation will be webcast live with slides 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. In addition to the licensing agreement with Xcel, POZEN has development and commercial alliances with GlaxoSmithKline 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.
About Xcel Pharmaceuticals
Xcel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on prescription products that treat disorders of the central nervous system (CNS). Xcel's portfolio includes four marketed products, two that are used to treat epilepsy and two that are used to treat migraine, and one product candidate to treat migraine. The Company's 96-person nationwide field sales organization promotes its products to high-prescribing epilepsy and migraine specialists. Xcel's strategy is to increase prescription demand for its current products through targeted sales and marketing efforts, to leverage its presence in the CNS market through the acquisition of late-stage development product candidates and additional marketed products, and to develop enhancements for its current products. For more information about Xcel Pharmaceuticals, please visit www.xcelpharmaceuticals.com. For more information about Xcel's products, please visit www.diastat.com, www.migranal.com, www.DHE45.com, and www.choosemysoline.com.
POZEN forward looking statements: 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 FDA approval of our product candidates, 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 June 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.
Xcel forward-looking statements: This press release contains forward-looking statements including targets, estimates, plans, expectations, goals and projections, which involve risks and uncertainties, including risks associated with receiving FDA approval for MT 300, our ability to successfully launch and grow MT 300, our ability to grow our products, our ability to acquire and integrate late-stage development product candidates and new products, our ability to develop and obtain regulatory approvals for product enhancements, our dependence on third parties for manufacturing, the competitiveness of the pharmaceutical industry, and other risks. Any forward-looking statements represent our best judgment at this time and are based on assumptions, factors and other conditions that could change. Any such changes could produce significantly different results. We do not update or revise any of our forward-looking statements even if experience or future events show that the projected results or events will not be realized.