Drugmaker Pozen ($POZN) says its API supplier has done everything the FDA asked after noting issues in an April plant inspection that led to Pozen getting a complete response letter (CRL) for two cardio drugs. Changes were made, the FDA was updated and an expert agreed things looked good, so the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
The Chapel Hill, NC, company announced the disappointing news and said it intended to request a sit-down with the FDA to see what it can do to get approval of its NDA.
Pozen said today that its supplier "confirmed that there has been no new inspection of the facility" and that the FDA's compliance division has 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," the company said in an explanation of its dilemma to investors. They weren't very sympathetic, selling off shares and sending its stock price down more than 20% in early trading.
The agency in the first CRL said it had no problems with the clinical data on the pair of drugs, which combine aspirin and the proton pump inhibitor omeprazole in two ratios, to reduce the risk of death for patients who have experienced heart attacks, strokes, chest pain or revascularization procedures. Instead, the FDA said, they were rejected because of deficiencies inspectors found at the site of its active ingredient supplier. Pozen has identified the API producer only as a "foreign" third-party API supplier. The agency told the company to come back with its application when those were fixed. That is what it thought had been done when it resubmitted the NDA in July.
"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," the company explained today.
Manufacturing issues have derailed any number of drug applications but some have managed to get past them. The FDA in March rejected a new oral, Type 2 diabetes drug from Eli Lilly ($LLY) and Boehringer Ingelheim because of "previously observed deficiencies" at a Boehringer Ingelheim plant. They made changes, went back to the FDA in June with a new drug application and in August got approval for what it calls Jardiance. On the other hand, California-based Impax Laboratories ($IPXL) has struggled for several years to get past ongoing manufacturing issues that have kept it from getting its Parkinson's drug Rytary approved by the FDA. In October the drugmaker cut its R&D staff by 42 jobs, a 25% reduction, to save money.
- read Pozen's announcement