Cilag, POZEN enter license agreement to develop and commercialize MT 400

Mar 23 2011

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has entered into a license agreement with Cilag GmbH International, a division of Johnson & Johnson, for the development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. MT 400 is POZEN's proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine. POZEN previously licensed U.S.-only rights to MT 400 to GlaxoSmithKline, who markets a different dose of MT 400 as Treximet® (sumatriptan and naproxen sodium).

Under the terms of the agreement, Cilag will be POZEN's exclusive licensee for MT 400 in the licensed territory and will be responsible for the manufacturing, development and commercialization of MT 400.

Cilag will make an initial upfront payment to POZEN, followed by a milestone payment to POZEN upon the approval of MT 400 by the National Health Surveillance Agency of Brazil. The agreement will expire on a country-by-country basis upon the 15th anniversary of the first commercial sale of MT 400 in each country. During the first 10 years of sales, Cilag will pay POZEN a high single digit royalty on net sales of MT 400, followed by a low single digit royalty during the next 5 years.

"We are pleased to have reached an agreement with Cilag to develop and commercialize MT 400 in several countries in Latin America," said Liz Cermak, Executive Vice President and Chief Commercial Officer of POZEN. "This is a first step in bringing this novel migraine product to the millions of migraine patients living outside of the United States. In addition, the income from this deal will help fuel the development and commercialization of our integrated aspirin 'PA' portfolio of products."

MT 400 has been proven to be superior to triptan monotherapy on multiple efficacy endpoints. In a previously published Phase 2 clinical trial involving 972 patients, POZEN announced that MT 400, using a marketed triptan and an NSAID, provided a greater than 50 percent 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.