Novasep moves eravacycline API to commercial-scale production

Novasep has won a contract to make commercial supplies of the API eravacycline, a next-generation infection fighter.

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.

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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.