Novasep, a leading supplier of services and technologies for the life sciences industry, announced that it has been selected by Tetraphase for the commercial manufacture of the active pharmaceutical ingredient (API) eravacycline, an antibiotic being developed for the treatment of life-threatening infections, including those caused by multidrug-resistant (MDR) Gram-negative bacteria.
Eravacycline is a novel, fully-synthetic tetracycline antibiotic in a Phase 3 program for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for eravacycline for both indications.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the MDR bacteria highlighted as urgent public health threats by the CDC. Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase’s pipeline includes three antibiotic clinical candidates: Eravacycline, which is in phase 3 clinical trials, and TP-271 and TP-6076, which are in phase 1 clinical trials.
This manufacturing agreement with Tetraphase is the result of a successful collaboration that started in 2014 with the clinical supply of eravacycline. Novasep will continue to produce eravacycline in its facility located in Chasse sur Rhône, France.
“Multidrug-resistant infections pose a serious threat to public health and the development of novel antibiotics is clearly a priority”, said Dr Michel Spagnol, Chairman and CEO of Novasep. “Tetraphase has developed a robust and innovative chemistry process for their lead candidate, eravacycline. We are extremely grateful for the opportunity to continue working with Tetraphase; this new strategic manufacturing agreement will further strengthen our relationship.”
As a CDMO, Novasep has a 30-year track-record in the scale up, validation and commercial supply of low-temperature chemistry under cGMP.