GSK / POZN / $25-80m migraine deal
RESEARCH TRIANGLE PARK & CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 12, 2003--GlaxoSmithKline (NYSE:GSK - News) and POZEN Inc. (NASDAQ:POZN - News), 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® (sumatriptan, sumatriptan succinate) or Amerge®(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. |
