|GlaxoSmithKline and POZEN Announce Licensing Agreement to Develop and Commercialize a Novel Migraine Treatment|
RESEARCH TRIANGLE PARK & CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 12, 2003--GlaxoSmithKline (NYSE:GSK) and POZEN Inc. (NASDAQ:POZN), announced today that they have signed an agreement for the development and commercialization of proprietary combinations of a triptan (5-HT1B/1D agonist) and a long-acting non-steroidal anti-inflammatory drug (NSAID) that may improve the effectiveness of acute treatment and provide sustained pain relief for patients suffering from migraine headaches. The combinations covered by the agreement are among the combinations that POZEN has referred to as MT 400.
Under the terms of the agreement, GSK will have exclusive rights in the United States to commercialize all combinations which combine either of GSK's currently marketed triptans, Imitrex(R) (sumatriptan, sumatriptan succinate) or Amerge(R)(naratriptan hydrochloride), with a long-acting NSAID. POZEN will be responsible for development, while GSK will provide formulation development and manufacturing. It is expected that the companies will commence Phase III trials under the agreement in 2004.
GSK will pay POZEN an upfront fee and an initial milestone payment totalling $25 million in 2003 with potential milestone payments over the next several years of $55 million relating to development progress, regulatory submissions and approvals. GSK will also pay POZEN royalties on sales of marketed products, and in addition, potential sales performance milestones of up to $80 million, if certain sales thresholds are achieved. The transaction will be notified under the Hart Scott Rodino notification program, and will become effective only upon approval of the transaction by the US Federal Trade Commission.
In a previously described Phase II clinical trial involving 972 patients, POZEN announced that MT 400, using a marketed triptan and an NSAID, provided a greater than 50% improvement for sustained pain relief over triptan monotherapy with a similar side effect profile. 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.
Christopher Viehbacher, President of US Pharmaceuticals, GSK, said, "Imitrex revolutionized the treatment of migraine and gave patients a highly effective, migraine-specific, non-sedating treatment. This agreement with POZEN is the next big step in our commitment to provide medicines that get patients pain-free and back on track." A recent study(1) of American migraine patients assessed patient desires in migraine treatments. This new compound is expected to address the top three concerns identified by patients in the study -- fast, complete and long-lasting pain relief.
John R. Plachetka, Pharm.D., POZEN's Chairman, President and Chief Executive Officer said, "As the pioneer of modern migraine treatment and the indisputable market leader, GSK represents the strongest commercial partner for this new product candidate. This agreement represents a significant achievement for POZEN and positions the company for strong future growth. We are pleased that GSK has entrusted POZEN with the responsibility for the development of this exciting new medicine, and along with GSK, are deeply committed to making this medicine available to millions of migraine sufferers."
Migraine afflicts approximately 28 million people in the United States alone, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: www.gsk.com.
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.
GSK Cautionary Statement regarding forward-looking statements: Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations include, but are not limited to, those described under 'Risk Factors' in the Operating and Financial Review and Prospects in GSK's Annual Report on Form 20-F for 2002.
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.
(1)Lipton, et.al., Headache, 1999;39:S20