Osteoarthritis drug Vimovo‘s sales disappointed early and its U.S. prescriptions have declined as of late, but for all of those commercialization pains, the drug has become an unexpected regulatory beacon for Pozen‘s (NASDAQ:POZN) latest drug candidate.
PA32540 is Pozen’s safer aspirin, a compound drug that the Chapel Hill, North Carolina company developed for secondary prevention of cardiovascular disease. The U.S. Food and Drug Administration has suggested that Pozen needs additional data to get approval for that full indication. To understand PA32540’s regulatory prospects, it helps to first understand Vimovo.
Vimovo combines the nonsteroidal anti-inflammatory drug (NSAID) naproxen with omeprazole, which reduces stomach irritation. Omeprazole is released immediately. Pozen’s delayed-release technology administers naproxen later. The drug was developed to give a treatment option to arthritis patients who can’t take NSAIDs because of ulcer risks. Vimovo was approved in the United States and Europe in 2010.
Pozen’s PA drug platform applies to the company’s delayed-release technology to aspirin to make safer aspirin therapies for a range of indications. PA32540 is the first drug to emerge from this platform.
Last week, Pozen disclosed that the FDA suggested it would approve PA32540 at the 325 mg dosage only for treating patients who have had coronary artery bypass graft surgery and in those patients only for a year. That’s a much smaller patient pool compared to the millions taking aspirin to prevent heart disease. The FDA wants Pozen to seek approval for the compound drug at the lower 81 mg dose to cover a broader range of patients. In fact, Pozen’s own market research shows that two-thirds of aspirin therapy patients take the 81 mg dose. But Pozen had expected getting approval at 325 mg would cover all secondary cardiovascular indications.
PA32540’s regulatory prospects might be smoother overseas and Pozen has Vimovo to thank for that. Pozen recently met with regulators in a European country to discuss PA62520, an aspirin combination drug being developed for pain relief. That country, which had approved Vimovo, is so convinced of omeprazole’s ability to reduce ulcers in this combination that it won’t require phase 3 studies on the drug. That could have implications for the cardiovascular approvals Pozen will seek in Europe and worldwide.
“Even though we may have added some heartburn to everybody by the FDA’s request for this lower dose here in the United States, outside of the United States we’ve been served up a great opportunity to shave time off getting into the marketplace with both a 100 mg and a 300 mg dose,” Pozen CEO John Plachetka explained in a conference call to discuss first-quarter financial results. “That could be a reference state for countries around the world.”
Vimovo may yet help Pozen with the FDA. As the company said in its regulatory filing, the company does have clinical data for 81 mg of aspirin combined with 40 mg of omeprazole. That data is similar to the information Pozen submitted to secure approval for Vimovo at a lower dose without a phase 3 trial, so Vimovo would offer a precedent.
At this point, Pozen does not know the exact course it will take with its PA32540 new drug application, though Plachetka said the company has no plans to pursue a phase 3 study. The PA32540’s drug application was expected to be filed in the third quarter and until the FDA dosage questions surfaced, the company’s application was nearly done. Plachetka said Pozen could file the application as planned and get approval only for the limited cardiovascular indications the FDA indicated. But Plachetka added that the FDA has not seen any of the data from the NDA package and he suggested the agency may decide to approve PA32540 for all of the previously discussed cardiovascular indications.
Pozen could also apply for approval of the lower dose that the FDA suggested. The company could delay its filing until it has all of the 81 mg aspirin data ready and ask for approval for secondary cardiovascular disease prevention.
Even though the drug filing details are still being determined, Pozen remains confident it can still land a drug partner to commercialize PA32540. Chief commercial officer Liz Cermak said that Pozen has been in “advanced discussions with a number of potential parties.” Those parties know about the FDA’s request for approval of the aspirin combination drug at 81 mg and they’ve been receptive because of the large number of patients taking aspirin at that dose.
“Having this additional dose is very positive from a prescription perspective,” she said.
The potential partners are still learning about the latest Pozen developments and some of them are not yet aware that at least one European country suggested three studies aren’t necessary for Pozen’s PA drugs. But Plachetka said he remains confident a deal will be done by the end of 2012. We should know well before then what course Pozen has chosen for its PA32540 drug filing.
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