The manufacturing problems at Sun Pharma’s key Halol, India, plant have taken the spark out of its drug development arm SPARC. For the second time, the FDA has stymied approval of a new drug from Sun's novel drug development group because of problems at the plant.
The India-based drugmaker reported on Friday that its Sun Pharma Advanced Research Company (SPARC) had received an FDA complete response letter for the novel epilepsy drug Elepsia XR (levetiracetam) that it licensed last year from SPARC. It said the application was denied after an inspection of the Halol facility.
"Satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XR can be granted," SPARC said in a statement.
The FDA had actually approved the drug in March of 2015, but even as SPARC was looking for marketing partners, the FDA returned with a CRL tied to the problems it had uncovered at the Halol plant, where the API for the epilepsy drug was being produced. It said the approval was being revoked because the plant was not in compliance at the time of the approval.
Sun has been dealing with issues at Halol for some time. The FDA issued a Form 483 in 2014 and then a warning letter in 2015 for the API plant. Those regulatory setbacks kept it from winning any new drug approvals from the facility, hurting Sun’s growth.
Sun Pharma announced last year that it was licensing the drug from SPARC for $10 million upfront and milestone payments. SPARC said that Sun’s established place in the U.S. market would give it a leg up in getting the drug to patients once it was reapproved. The novel once-a-day formulation of levetiracetam is expected to improve convenience and compliance for patients who currently must take multiple pills of levetiracetam every day.
It also reported that it had taken detailed remediation steps at Halol to restore cGMP compliance. It has invested in new equipment and done additional employee training that it believed would restore its cGMP standing with the FDA. But those hopes, and the chance for approval of SPARC's drug, were dashed late last year when Sun said that instead of a close-out letter, the reinspection resulted in a new Form 483 with more citations.
Sun is just one of a growing number of drugmakers, including large companies like Sanofi, Regeneron and AstraZeneca and smaller players like Tesaro and Momenta, that have had drug approvals stopped in their tracks because of FDA concerns over manufacturing processes.