Pozen (NASDAQ:POZN), now prepping to file a new drug application for its safer form of aspirin, has run into a slight regulatory headache.
The company had looked on track way for a third-quarter drug filing on its combination aspirin product that targets the large market for cardiovascular disease prevention. Pozen even got its phase 3 clinical trial results back early. But during a recent meeting with the U.S. Food and Drug Administration to discuss the submission, the agency suggested the company also seek approval for the drug at a lower dose, Pozen said in a regulatory filing. Without the additional approval at a lower dose formulation, the FDA said it might limit the drug’s use to patients after they’ve had coronary artery bypass graft surgery, or CABG, and that treatment would be limited to one year. That would also limit Pozen’s potential market for PA32540. Pozen releases its first-quarter earnings tomorrow. But chances are, analysts and investors will want to discuss the next steps for PA32540, which is the focus of the small, Chapel Hill, North Carolina company’s big drug partnership ambitions.
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PA32540 is delayed release aspirin combined with immediately released omeprazole to reduce stomach acid. The combination offers the health benefits of aspirin while reducing the gastrointestinal irritation that has made aspirin therapy intolerable for some patients. Pozen’s first target is secondary prevention of cardiovascular disease. The company tested PA32540 in clinical trials dosing aspirin at 325 mg combined with 40 mg of omeprazole.
Pozen said the FDA might have concerns that doctors need another dose at a lower level, according to the regulatory filing. Current cardiovascular treatment guidelines recommend aspirin doses of 81 mg or 162 mg for most indications. Pozen’s takeaway from its FDA meeting is that without a formulation containing a lower dose, “physicians will not have a full range of dosing options available to prescribe in accordance with current cardiovascular treatment guidelines.”
CABG surgeries are still a big market with more than 1 million such surgeries performed worldwide, according to the American Heart Association. But Jason Napodano, an analyst with Zacks Investment Research, notes in a post at Seeking Alpha that Pozen hoped to reach a much broader opportunity. In the United States alone, more than 50 million people take aspirin as part of daily therapy to prevent cardiovascular disease.
Pozen does have clinical data for a product that contains aspirin at the 81 mg dose combined with the 40 mg of omeprazole: PA8140. The company plans to file this data along with other information as part of its NDA filing to the FDA. If Pozen has reason for hope here, it’s because this package will be similar to a data submission the company made for one of its other products, arthritis drug Vimovo. That drug, which uses the same delayed-release technology as PA32540, did not need another phase 3 clinical trial to secure FDA approval at a lower dose formulation. But pulling together this package could delay an NDA six months beyond the original plans for a third-quarter filing.
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The FDA’s questions come as Pozen actively shops for a drug partner to commercialize PA32540 globally and perhaps also take on the company’s PA platform to develop additional aspirin therapy products. Pozen, which had been seeking terms superior to those of previous partnership deals with GlaxoSmithKline (NYSE:GSK) and AstraZeneca (NYSE:AZN), could lose a little bargaining power now.
Napodano says a deal is still possible, but he sees three possible outcomes after the NDA filing:
Approval. The FDA approves Pozen’s drug for secondary prevention of cardiovascular disease in patients at risk for gastric ulcers at both the 325 mg and the 81 mg doses.
Limited approval. The FDA approves the drug only at the 325 mg dose for CABG surgery patients, with treatment not to exceed one year.
A complete response letter. The FDA asks for a phase 3 study on the compound at the 81 mg dosage.
Pozen said in the filing that it does not plan to conduct additional phase 3 trials. But the company adds that it has no guarantee that the data it submits will be enough for FDA approval. The company said it would address the matter further in its quarterly conference call.