French CDMO Novasep, which has been making clinical supplies for a new-generation antibiotic being developed by U.S.-based Tetraphase Pharmaceuticals, will now start production for a potential commercial launch next year.
Novasep said it will continue to manufacture eravacycline at its facility in Chasse-sur-Rhône, France, where it has produced the clinical supply of the API since 2014. Eravacycline is a novel, fully synthetic tetracycline antibiotic under development for the treatment of life-threatening infections, including those caused by multidrug-resistant Gram-negative bacteria.
In its third-quarter report last month, Watertown, Massachusetts-based Tetraphase said that it had completed a phase 3 clinical trial which it will use along with data from an earlier trial for its NDA to treat complicated intra-abdominal infections and complicated urinary tract infections. It said it expects to file the NDA in the first quarter of 2018.
The FDA told Tetraphase in May 2016 that it would need further clinical data before it could consider approving eravacycline. Tetraphase has also submitted a Marketing Authorisation Application in Europe for the same use of eravacycline.