Wockhardt’s latest FDA regulatory problems may affect the approval of the first product for U.S. biotech Cempra that is in the home stretch of the approval process for a new antibiotic for pneumonia.
Cempra’s drug candidate solithromycin is slated to go before the Antimicrobial Drugs Advisory Committee Friday and has PDUFA dates of Dec. 27 and Dec. 28. But the main source of the API is being produced at a Wockhardt plant that the FDA banned in August. The company is scrambling to get another supplier approved by the FDA as soon as possible, but Cempra said the FDA “could withhold or defer potential approval until they are satisfied that commercial supplies of solithromycin meet their CMC requirements.”
Cempra said in its quarterly SEC filing last week that the Wockhardt plant in Ankleshwar, India, where the solithromycin API is being produced, was put on the FDA import alert list several months after the agency accepted the drug application from the Chapel Hill, NC-based company.
"Based on an in person meeting held with the FDA in late October, we currently believe the FDA may not allow us to use API produced by Wockhardt for approval and commercial supply of solithromycin, and we are preparing to provide the FDA with data from API that we are manufacturing with another API supplier,” Cempra said in its filing.
The biotech said that it believes the FDA concerns are about Wockhardt and “not specifically focused on Cempra’s product or processes.” It said its personnel had closely supervised production of the solithromycin API “and we continue to have confidence in the solithromycin manufacturing process and the quality of our drug product.”
The company does have a backup plan. In anticipation of approval, it has been working with API maker Uquifa since 2014 to produce solithromycin at a plant in Cuernavaca, Mexico. Cempra said that based on its talks with the FDA, it has expedited API manufacturing work with Uquifa and expects to be able to provide data to the FDA over the next several months. Cempra said, if that data is acceptable to the FDA, the company would still be in a position to "launch solithromycin for the 2017-2018 influenza/pneumonia season.”
India’s Wockhardt has been in hot water with the FDA since 2013, when the agency banned products from its plants in Waluj and Chikalthana for a variety of problems that were laid out in warning letters.
Manufacturing problems, both by contractors and at plants owned by drugmakers themselves, have sidelined a number of products this year. On Friday, Sanofi and R&D partner Regeneron had approval delayed for their experimental IL-6 inhibitor sarilumab, an expected blockbuster that will compete with AbbVie’s Humira. The two received a complete response letter for the drug tied to “manufacturing deficiencies” at a Sanofi fill-finish facility, delaying its potential approval. A handful of other drugmakers have faced essentially the same the issue this year.
- here’s the SEC filing