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POZEN and Xcel Pharmaceuticals Announce Licensing Agreement to Commercialize
Injectable Migraine Treatment MT 300
Chapel Hill, NC & San Diego, CA, 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."
Migraine Market
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.
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.
About POZEN
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.
CONTACT:
At Edgemont Capital Partners
David K. Blume, Managing Director
Phone: 212-867-8935 Fax: 212-214-0911
Jeff B. Swearingen, Principal
Phone: 212-867-8935 Fax: 212-937-3816 |
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