Washington Editor

Pozen Inc. submitted an application to the FDA for MT 100, an oral first-line therapy for the treatment of migraine.

The new drug application lands at the government's door 17 months after Pozen, of Chapel Hill, N.C., was notified by the agency that MT 100 was considered a new chemical entity and would have to pass rat and mouse carcinogenicity studies before it could make it to market. (See BioWorld Today, Jan. 29, 2001.)

Pozen had not considered MT 100 as such because it is made from metoclopramide (for nausea control) and naproxen sodium (a pain reliever), two chemicals that have been on the market since the 1970s. Nevertheless, the company finished a successful study in mice, and the rat study is ongoing. John Plachetka, Pozen's chairman, president and CEO, told BioWorld Today the FDA agreed to review the NDA and accept results of the rat carcinogenicity study in early 2004.

The MT 100 application is Pozen's third regulatory filing in the past 10 months. In December, the company filed for approval of MT 300, an injectable formulation of dihydroergotamine mesylate dosed through a prefilled syringe, for severe migraine. In October 2002, the company filed for approval of MT 100 in the UK. (See BioWorld Today, Dec. 18, 2002.)

Plachetka views that as a pretty good record, particularly for a company of 27 employees and one that developed its own drug candidates.

"We are a very efficient, very professional drug development company," he said. "We made as many filings as some major companies with four or five times as many employees in one department. This is a huge boost for Pozen's prospects in the near term and a continuing endorsement for the credibility of the company. We told people a year ago we would be filing this mid-year and we gave additional guidance at the beginning of the year saying it would be July. We did our filing exactly as we told everybody."

And if all goes according to plan, MT 100 and MT 300 could be on the U.S. market during the second half of 2004, while MT 100 is expected to enter the market in the UK around mid-2004.

All told, Plachetka said Pozen has conducted at least 15 trials on MT 100, including seven Phase III studies. As part of its NDA, the company submitted data on 7,700 migraine patients who participated in Phase II, III and IIIb trials. Of the participants, about 3,700 received some form of MT 100.

In two large, well controlled, head-to-head studies, MT 100 delivered migraine relief comparable to Imitrex, a triptan, marketed by London-based GlaxoSmithKline plc. Pozen said there's a reduced risk of cardiovascular side effects in MT 100 compared to triptans.

Plachetka estimated the worldwide migraine market at $3 billion a year. However, he said larger companies believe the potential market is actually $5 billion to $7 billion a year.

"Only 50 percent of patients see a doctor, and of those, only about half are taking a prescription drug," he said. "There's a huge unmet need."

MT 100, MT 300 and MT 400 are poised to capture some of that market. In particular, Plachetka said MT 400 will eventually dominate because it is twice as good as anything available. MT 400 is a platform technology that combines triptan with a long-acting, nonsteroidal, anti-inflammatory compound. GSK licensed a technology under the MT 400 platform in a deal potentially worth $160 million. (See BioWorld Today, June 13, 2003.)

Meanwhile, Pozen is in discussions with possible partners for MT 100 and MT 300.

Recently the company licensed MT 100 to Nycomed Danmark ApS, of Roskilde, Denmark, for exclusive Nordic sales rights. Nycomed would sell MT 100 in Denmark, Sweden, Norway and Finland. Nycomed will pay Pozen a $500,000 up-front fee as well as potential milestones totaling $1 million relating to regulatory approvals, as well as double-digit royalties on sales.

Pozen's stock (NASDAQ:POZN) closed Thursday at $13.10, unchanged.