MT 400 is POZEN’s proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine.
MT 400 has been proven to be superior to triptan monotherapy on multiple efficacy endpoints. In a previously published Phase II clinical trial involving 972 patients, MT 400, which uses a marketed triptan and an NSAID, provided a 65 percent improvement for sustained pain relief over triptan monotherapy with a similar side effect profile. Sustained pain relief is defined as patients that achieved pain relief within two hours of dosing and then neither relapsed nor used rescue medicine over the next 22 hours.
In March 2011, POZEN announced that Cilag GmbH International, a division of Johnson & Johnson, will be the exclusive licensee for MT 400 in Brazil, Colombia, Ecuador and Peru 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 five years.
In May 2012, POZEN announced that it has entered into a license agreement with Desitin Arzneimittel GmbH, for the development and commercialization of MT 400 for the 27 countries of the European Union, as well as Switzerland and Norway. Under the terms of the agreement, Desitin will be POZEN’s exclusive licensee for MT 400 in the licensed territory and will be responsible for the remaining clinical development, manufacturing, and commercialization of MT 400.
POZEN is actively seeking other licensing partners for the additional available territories.
POZEN has licensed U.S.-only rights to MT 400 to GlaxoSmithKline, who markets a different dose of MT 400 as Treximet® (sumatriptan / naproxen sodium).