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This Pozen Drug's Not for Migraines

Posted on: Thursday, 3 November 2005, 18:00 CST

By Anne Krishnan, The Herald-Sun, Durham, N.C.

Nov. 3--After nine years as a migraine drug development company, Pozen Inc.'s pipeline is moving in a different direction -- and quickly.

The Chapel Hill firm on Wednesday announced the results of early studies for a drug designed to prevent the stomach irritation and ulcers that can result from painkillers called NSAIDs. The drug, called PN 100, significantly reduced damage to patients' gastrointestinal systems in a 14-day limited trial, Pozen reported.

"We call it a safer NSAID," said spokeswoman Fran Barsky. By summer, a similar drug should be in Phase III clinical trials in arthritis patients.

It's not uncommon for drug development companies to have shifts in their pipelines over time, but the development of the new drugs hasn't been as dramatic as it may seem, said Pozen CEO John Plachetka.

The company started thinking about developing a safer NSAID about five years ago when problems first surfaced with Vioxx, he said, and the company filed its patent application in 2002. The patent was granted in August.

However, most investors only know about Pozen's high-profile relationship with GlaxoSmithKline regarding the migraine drug Trexima, said Ken Trbovich, a specialty pharmaceuticals analyst for RBC Capital Markets.

The perceived broadening of the company's pipeline taps into an unmet need and could potentially make Pozen a more attractive investment, he said. The company's stock closed at $9.60, down 13 cents.

"All the eggs are in one basket," he said. "This helps to diversify the risk."

PN 100 and PN 200, the drug that will enter clinical trials next year, combine the naproxen painkiller with proton pump inhibitors that lower the acidity in the stomach. Each dose coats a naproxen core with a layer that prevents activation until the stomach acid decreases to a certain level. The outside layer is the proton pump inhibitor, which immediately works to reduce acid in the stomach.

Plachetka envisions as many as five new therapies using different drugs and dosages from the single patent. In addition to PN 100 and PN 200, the company is developing a combination that replaces naproxen with aspirin.

And beyond preventing ulcers, the drugs also should help increase patient compliance, he said.

"We're looking at practical solutions to difficult therapeutic problems that physicians and patients face every day," Plachetka said.

There are 60 million patients with arthritis and there's a 25 percent chance that someone will develop an ulcer after two weeks of continuous NSAID use, Plachetka said.

"There's a huge need," he said. "There's a very strong effort behind moving this into the clinic."

PN 200 is scheduled to enter Phase III clinical trials -- the last phase before regulatory approval -- in the second quarter of 2006, skipping Phase II with the U.S. Food and Drug Administration's permission. Both of the drugs in PN 200 have already been approved for use separately.

On a mission While the new drugs are a departure from Pozen's earlier migraine medicines, they're all the products of a drug development process that harnesses the benefits of existing drugs rather than starting from scratch.

"We think that the failure rate of developing new products from existing raw ingredients is much lower than if you try to find that diamond in the rough that turns out to be the next blockbuster drug," Plachetka said.

Wanted: Partner The company also is working on securing a partner to commercialize PN 200. GlaxoSmithKline will take Trexima, if approved, to market.

"It's not our mission to be a fully integrated drug company," Plachetka said. "The world does not need more drug salesmen. The world needs more drug products."

But the drug's sales potential may depend on who's commercializing it, Trbovich said.

"If it's a company like GlaxoSmithKline, a top-tier major pharmaceutical company, this product would have very significant potential," he said.

The analyst wrote in a research report that the aspirin and naproxen combinations could each tap markets of $1 billion or more. Pozen also has a potential blockbuster on its hands with Trexima, which should receive an answer from the FDA by mid-2006. And Plachetka said he expects another migraine drug, MT 100, to be approved in the United Kingdom this year.

Revenue from drug sales would be welcome news for Pozen, which has spent $124 million on its drug development efforts since 1996, according to filings with the U.S. Securities and Exchange Commission. The company said it had cash and cash equivalents of $31.3 million as of Sept. 30, and it received a $20 million milestone payment from GSK last month.

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Source: The Herald-Sun

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