|POZEN and Nycomed Announce Licensing Agreement to Commercialize Migraine Therapy MT 100 in Nordic Countries|
CHAPEL HILL, N.C. & ROSKILDE, Denmark--(BUSINESS WIRE)--July 1, 2003--POZEN Inc. (NASDAQ: POZN), and Nycomed Danmark ApS announced today that they have signed a licensing agreement for the commercialization of MT 100(TM) in four Nordic countries. MT 100 is being developed as an oral first-line therapy designed to provide effective migraine relief.
Under the terms of the agreement, Nycomed will have exclusive rights in Denmark, Sweden, Norway, and Finland to commercialize MT 100. The Nordic countries account for approximately 18% of the European triptan market on a Euro basis. Nycomed will pay POZEN an upfront fee of $500,000 and potential milestone payments totaling $1 million relating to regulatory approvals. Nycomed will also pay POZEN a double-digit royalty rate on sales of MT 100.
"This license marks an important first step in the commercialization of MT 100 in Europe," said John R. Plachetka, Pharm.D., chairman, president, and chief executive officer of POZEN. "Nycomed is a European pharmaceutical company with a strong Nordic base, and we believe they are well-positioned to maximize the commercial potential of MT 100 in one of the most significant markets in Europe."
Hakan Bjorklund, chief executive officer of Nycomed, stated, "Migraine therapy has become an important focus area for Nycomed in the Nordic area. We are pleased to have the opportunity to deploy our expertise in this area on an exciting innovative product such as MT 100. With MT 100 and Almogran(R), which we are marketing for Almirall in the Nordic territory, we are well-positioned to provide migraine patients with the full spectrum of therapeutic choices."
In October 2002, POZEN submitted a Marketing Authorization Application for MT 100 to the Medicines Control Agency (MCA) in the United Kingdom. If approved in the U.K., POZEN will seek approval in select European countries, including Denmark, Sweden, Norway, and Finland, through the European Union Mutual Recognition Procedure. This procedure allows other European countries to grant national approvals based upon the review and endorsement of the MCA in the U.K. Nycomed will be responsible for obtaining the necessary pricing and reimbursement approvals in Denmark, Sweden, Norway, and Finland.
MT 100 is being developed as an oral, first-line treatment for migraine. It is a patented sequential release tablet containing naproxen sodium, which relieves pain and reduces inflammation, and metoclopramide hydrochloride, which accelerates the absorption of naproxen and relieves nausea. The results from two head-to-head studies show that MT 100 provides comparable efficacy to Imitrex(R) 50 mg, the leading prescription product for migraine worldwide, but has less risk of cardiosvascular side effects compared to Imitrex.
Migraine is characterized by recurring attacks of headache that are often accompanied by nausea, and sensitivity to light and sound. In the most severe attacks, migraine sufferers are unable to pursue basic daily activities. The average migraine patient experiences attacks throughout his or her adult life.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. The company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN." For detailed company information, see POZEN's website: www.pozen.com.
Nycomed is a European-focused pharmaceutical company. Nycomed sources, develops, manufactures and markets specialist and prescription pharmaceuticals and consumer health products. Dedicated sales teams target general practitioners, hospital specialists and pharmacies. In-house capabilities also include international product sourcing, late-stage clinical trials, local and European registration and life-cycle management. Nycomed has 36 sales offices in 15 European markets including the CIS, and manufacturing facilities in Austria, Belgium, Denmark, Estonia, Finland and Norway. Headquartered in Roskilde, Denmark, the Company's 2002 revenues amounted to EUR 562.9 million, with EBITDA of EUR 108.3 million. The total number of employees is approximately 2,800, of whom more than half are within sales and marketing. Nycomed is on the internet at www.nycomed.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 enter into or maintain, 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 March 31, 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.