Pozen has a new CEO to deal with the FDA's API concerns

When drugmaker Pozen got a second FDA complete response letter (CRL) tied to issues with its API supplier, the company insisted it had already done everything the agency asked. The Chapel Hill, NC, company said it intended to sit down with the FDA to see what it could do to move along its NDA for a new-gen aspirin product. But it won't be longtime CEO John Plachetka directing those talks any longer. The "fiery" founder is out at Pozen in one of several steps the company announced this week.

Former Pozen CEO John Plachetka

Pozen ($POZN) has replaced the retiring Plachetka with Adrian Adams, who was CEO at Auxilium until it was sold off to Endo ($ENDP) in January. Andrew Koven, a colleague of Adams at Auxilium, was named president. In addition, the company said it had set up a European subsidiary to serve as a platform for international growth. But given that it is in Ireland, where many companies moved to take advantage of its corporately compelling tax rates, FiercePharma reports that the moves suggest the company might be preparing itself for a sale.

Pozen offered no update on its NDA for Yosprala, an aspirin product intended to reduce GI complications. It said only that the top-tier management changes were "critical in helping Pozen in assessing our strategic options at this time and leading Yosprala through the final anticipated stages of approval and into commercial launch." It said that might happen next year.

The company got the CRL after an inspection of its "foreign third-party API supplier" in April 2014 raised questions in the mind of the FDA. When it received another identical letter in December, Pozen insisted that its supplier had done what the FDA had asked and that an expert had confirmed that it had. The problem was that the FDA compliance division had been too busy to check out the changes ahead of the FDA deadline on its application.

Pozen complained at the time that the FDA's compliance division had provided no feedback on "the supplier's action plan and progress on the plan to address the deficiencies, other than informing the supplier that the matter is under review and that the division has many competing priorities."

Manufacturing issues have derailed any number of drug applications, but some have managed to get past them. In March 2014, the FDA rejected Jardiance, a new oral Type 2 diabetes drug from Eli Lilly ($LLY) and Boehringer Ingelheim, because of "previously observed deficiencies" at a Boehringer Ingelheim plant. The companies made changes, went back to the FDA in June with a new drug application and in August got approval.

- here's the release

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