Pozen Inc. made it clear some time ago it expected to file a new drug application for MT 300, its migraine treatment, by the end of 2002. On Tuesday it said the regulatory submission was in the FDA's hands.
"It's wonderful to hit your milestones," said John Plachetka, Pozen's CEO, president and chairman. "It's always a challenge to set out milestones at the beginning of the year and then hit them. We hit all of them that we set out at the beginning of the year."
MT 300 is a formulation of dihydroergotamine mesylate that is dosed via a pre-filled syringe and designed for the acute treatment of migraine with or without aura. The current leading injection treatment for migraine is Imitrex, sold by GlaxoSmithKline plc, of London. While that product is "the dominant player in the field" and brings GSK between $200 million and $225 million per year, Plachetka said, MT 300 should get its shot.
"I think a lot of people will try [MT 300]," he told BioWorld Today. "A lot of people will like it, too. It's a very good new product in this field."
As of now, MT 300 is unpartnered, but Plachetka said he thinks "there is a fair level of interest for the second injectable pain [drug] behind Imitrex," and Pozen is looking to sign a deal.
MT 100 is Pozen's oral therapy for migraine. In October, Chapel Hill, N.C.-based Pozen said it submitted a marketing authorization application in the UK. The product is not yet approved in the U.S., although clinical studies are complete and the last piece of the filing puzzle - a rat carcinogenicity study - is down to its final seven months, Plachetka said.
"MT 100 is moving along," he said, adding that the rat study should end in August. "Data are expected from that at the end of next year, but the NDA will go in this summer." The FDA has allowed Pozen to submit the clinical aspects of the program before the rat study data are in hand, meaning that Pozen should see "regulatory action in the second quarter of 2004," Plachetka said.
MT 400, another oral treatment for migraine, should move into Phase III studies in the first half of 2003, he said.
The trio of migraine products paint Pozen as a migraine and pain veteran, but as companies finish submitting in one area, Plachetka said, they often branch into others, something he called a "natural evolution."
But, he said, "Pain is an area that we are very, very good at. We aren't going to abandon that by any means."
Where Pozen plans to go in 2003 will be addressed soon, but after a year of achieving goals, Plachetka looked back with satisfaction.
"I'm really proud of the progress we've made as a company," he said. "We made two major regulatory filings in one year and we are only 27 employees."
Pozen's stock (NASDAQ:POZN) fell 21 cents Tuesday to close at $4.80.