POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, has entered into a licence 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.
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 rights of the same dosage strength of MT 400 to Cilag GmbH International, a division of Johnson & Johnson, for four Latin American countries. POZEN also licensed US-only rights to MT 400 to GlaxoSmithKline, which markets a different dose of MT 400 known as Treximet (sumatriptan and naproxen sodium).
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.
Desitin will make an initial upfront payment to POZEN, followed by milestone payments related to the development and launch of MT 400 in certain specified countries. The pre-commercialization payments will total $3.0 million, $0.5 million of which is due on signing. 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, unless terminated earlier. Desitin will pay POZEN a double digit royalty on net sales of MT 400 that increases based on annual sales volume.
“We are pleased to have reached an agreement with Desitin to develop and commercialize MT 400 in the EU, Switzerland and Norway,” said Liz Cermak, executive vice president and chief commercial officer of POZEN. "They have a strong European presence and history of success in marketing CNS products. This is yet another important step in bringing this novel migraine product to the millions of migraine patients living outside of the United States."
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, POZEN announced that MT 400, using a marketed triptan and an NSAID, provided a greater than 50 per cent 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.
Migraine afflicts between 10-12 percent of people, 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.
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs.