The FDA again rejected Pozen's ($POZN) pair of treatments designed to help patients deal with cardiovascular disease, citing the same third-party manufacturing issues that tanked the last application. Pozen claims the supplier has since rectified those concerns but that the agency has been less than cooperative in the process.
Pozen's drugs combine aspirin and the proton pump inhibitor omeprazole in two ratios, ideally reducing the risk of death for patients who have experienced heart attacks, strokes, chest pain or revascularization procedures. Back in April, the FDA rejected both candidates after noting some deficiencies at a site run by Pozen's unnamed active ingredient supplier, pointing to no problems with the clinical data and telling the company to come back when it had fixed the manufacturing problems.
According to Pozen, its supplier carried out the FDA's wishes, laying out a corrective plan and updating the agency on its progress. However, the FDA hasn't conducted a repeat inspection, and its compliance division has been unresponsive "other than informing the supplier that the matter is under review and that the division has many competing priorities," the company said in a statement.
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| John Plachetka |
Now, enduring a second rejection with "identical wording" to the first, Pozen is caught in regulatory limbo. FDA rules allow the company to request a meeting to discuss what needs to be done to get the process moving, and Pozen intends to do just that as soon as possible, CEO John Plachetka said.
"Based on inspections at the site by an expert consultant we retained and our review of all relevant documents and communications with the supplier's personnel, we believe that the FDA issues raised during the April inspection have been adequately addressed," Plachetka said in a statement. "So, our goal continues to be to do everything we can to assist the FDA compliance division with their review and to encourage them to move to completion of their review as soon as possible since this remains the only outstanding issue."
The new rejection sent Pozen's shares down about 23% on Wednesday morning.
Pozen took a blow earlier this month when former partner Sanofi ($SNY) walked away from its in-development aspirin combinations. Under a 2013 deal, the French drugmaker paid $15 million up front for the U.S. rights to Pozen's drugs, to be marketed as Yosprala. Sanofi had promised up to $20 million more if Pozen came through on some development and regulatory milestones.
- read the statement