By Matthew Willett

Migraine medication maker Pozen Inc. watched its share price get cut in half Friday when FDA-requested carcinogenicity studies threatened its new drug application timeline for MT 100, a metoclopramide HCl and naproxen sodium formulation.

Pozen's shares (NASDAQ:POZN) fell $6.375 Friday, or 49 percent, to close at $6.625.

Pozen had requested a waiver of carcinogenicity studies of MT 100, a combination of two approved drugs. Now the company has requested a consultation with the agency to determine a model for those studies to include in its NDA submission.

One outlook has the company submitting this year, as planned. Another possibility, Pozen CEO John Plachetka said, is a delay of up to 18 months.

"We have to talk to the FDA to work out a package of studies that are mutually agreeable," Plachetka told BioWorld Today. "We think it's going to be about 90 days before we get a final resolution about what action is required. We're confident that we'll work out an agreement with them that satisfies all their concerns and stay within the appropriate guidelines and stay reasonably in time with our schedule."

Pacific Growth Equities analyst Tom Dietz said in a research note, "We believe that there will be uncertainty in the timing of MT 100 for at least two to three months while Pozen attempts to reverse or revise the decision of the FDA."

Dietz agreed that the request from the FDA could delay Pozen's NDA by up to 18 months. However, he said another possibility is there would be no delay. He added that the request from the FDA shouldn't delay Pozen's efforts to partner the drug candidate this year.

MT 100 has completed five Phase III studies. Plachetka said the drug candidate has shown efficacy on the level of Imitrex, GlaxoSmithKline plc's market-leading migraine therapeutic, without the cardiovascular dangers Imitrex carries.

"MT 100 is a proprietary product that combines a very fast-release metoclopramide followed by the release of naproxen sodium in a single tablet," Plachetka explained. "In clinical studies to date we've shown that the product has outstanding efficacy against placebo, and several Phase II and Phase III trials indicated it relieved all the symptoms of migraine quickly and in a lasting fashion."

He added that Pozen submitted a variety of reasons for a waiver of carcinogenicity studies.

"We've shown no interaction between the two against each other," Plachetka said. "These drugs have been on the market well over 20 years, and they're pretty safe drugs. The FDA does have a procedure for dealing with these things, and we're following the normal procedure."

Pozen completed its initial public offering in November, offering 5.75 million shares for total proceeds to the company of $86.3 million. The NDA for MT 100 is the company's first.

Meanwhile, he said, other anti-migraine therapeutics are moving up the pipeline.

"We have the broadest portfolio of migraine drugs in the business, and MT 100 is just one of those drugs," he said. "From the looks of the stock price, it looks like people discounted all the other things we have in the pipeline, which I think isn't the wisest thing to do. We've got plenty of ammunition in the arsenal, and a lot of value at Pozen."

The most advanced drug aside from MT 100 is MT 300, an injectable dihydroergotamine mesylate compound for severe migraine pain, which is in Phase II testing. MT 400, a combination triptan and nonsteroidal anti-inflammatory, and MT 500, an in-licensed 5HT2b inhibitor, are both in Phase I testing.

Plachetka said MT 500, designed to prevent migraines, should enter Phase II testing this summer. MT 400 began a Phase II trial in November.

Plachetka concluded that the request for information by the FDA wasn't expected, but that the hurdle isn't one that should seriously delay approval for MT 100.

"It doesn't happen every day. Two approved drugs in the innovative formulation we have would rarely cause any major concerns, and I don't think it caused major concerns in this circumstance. You need to go through the NDA checklist, and the checklist says you have to provide a good reason why you don't need to do carcinogenicity studies or you have to do them."

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