Pozen Inc. found a partner for a migraine product approaching approval.

The Chapel Hill, N.C.-based company entered an agreement to allow Xcel Pharmaceuticals Inc. to commercialize MT 300, an improved and highly purified formulation of dihydroergotamine mesylate. The injectable product is being developed in a prefilled syringe suitable for at-home use.

San Diego-based Xcel already sells two other dihydroergotamine mesylate therapies - an injectable product called D.H.E. 45 and a nasal spray product called Migranal.

"This tells people that we do partnerships when we say we will," Pozen Chairman, President and CEO John Plachetka told BioWorld Today. "It's the third big deal of the year for us."

In exchange for exclusive U.S. sales rights, Xcel is paying Pozen a $2 million up-front fee and potential milestone payments of up to $8 million due upon certain regulatory approvals and the achievement of a predetermined sales threshold on MT 300. Xcel also would pay double-digit royalties on combined annual net sales of MT 300 and D.H.E. 45.

Pozen said the royalty rates would start in the low double digits and increase based on the achievement of predetermined net sales thresholds.

"Really from day one, Xcel was the obvious partner because they were already selling D.H.E. 45," Plachetka said. "This allows them to transfer, if they choose, all their D.H.E. 45 business over to MT 300."

He added that a loyal customer base could continue to opt for D.H.E. 45, though he said a majority of patients eventually would choose MT 300. Plachetka noted that Pozen does not plan to license the product overseas, the result, he said, of a lack of European interest in dihydroergotamine products.

For Xcel, MT 300 fits into its existing commercial infrastructure that includes a 96-person field sales force. Xcel is in a quiet period and could not address sales forecasts, or anything related to the deal, though Plachetka said Pozen typically has projected an annual range between $30 million and $50 million.

Pozen filed a new drug application for the product at the end of last year, a submission still under review at the FDA. Data from two Phase III trials that included more than 1,200 migraine patients showed a statistically significant improvement in the percentage of MT 300 patients achieving pain relief at two hours as well as sustained pain relief when compared to placebo. Plachetka said approval could come in the next six to nine months. (See BioWorld Today, Dec. 18, 2002.)

Outside of the latest MT 300 news, it has been a busy summer for Pozen.

A little more than a month ago, the company submitted a new drug application for MT 100, an oral first-line migraine therapy. But before the FDA will act, Pozen must complete carcinogenicity studies in mice and rats as the agency considers the product a new chemical entity. The mouse study succeeded, while the rat study continues. MT 100 is comprised of metoclopramide (for nausea control) and naproxen sodium (a pain reliever), two products marketed since the 1970s. (See BioWorld Today, Aug. 1, 2003, and Jan. 29, 2001.)

Plachetka said Pozen also would find a partner for the product, which has been studied in seven Phase III trials, following the rat study. He said the company expects results by the end of the year. Pozen already licensed MT 100's exclusive Nordic sales rights to Nycomed Danmark ApS, of Roskilde, Denmark.

"It is possible we could have two products that sell in the second half of 2004," Plachetka said. "It's a great position for a company that's traditionally had a burn rate of only $20 million to $22 million and only 27 employees. And now that sales will come in, our spending on these products is almost over. All money that we will get from this point forward just drops right to the bottom line."

Earlier this summer, Pozen made its biggest splash, in a potential $160 million licensing deal with GlaxoSmithKline plc. The London-based pharmaceutical firm, which sells a triptan called Imitrex, acquired a Pozen platform technology called MT 400, which combines triptan with a long-acting, nonsteroidal, anti-inflammatory compound. (See BioWorld Today, June 13, 2003.)

Beyond the stable of migraine products, Plachetka said Pozen's research efforts would continue to focus on pain therapeutics. In July, the company licensed from Nycomed a compound called lornoxicam, a nonsteroidal anti-inflammatory drug, and he said other research opportunities would be disclosed in the next six months to a year.

Pozen's stock (NASDAQ:POZN) rose 12 cents Thursday to close at $17.12.