Novasep in API Supply PactBy
Novasep, a Lyon, France-headquartered contract manufacturing organization and life-science service provider, has partnered with Tetraphase Pharmaceuticals, a Watertown, Massachusetts-based clinical-stage biopharmaceutical company, for the commercial manufacture of the active pharmaceutical ingredient (API) eravacycline, an antibiotic being developed for treating infections, including those caused by multidrug-resistant gram-negative bacteria.
Eravacycline is a fully synthetic tetracycline antibiotic in a Phase III program for treating intra-abdominal infections and urinary tract infections. The US Food and Drug Administration designated the drug as a Qualified Infectious Disease Product (QIPD) and has provided fast track designations for eravacycline for both indications. QIPD designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act to encourage development of new antibiotics.
The manufacturing agreement with Tetraphase is the result of a collaboration between the two companies that started in 2014 with the clinical supply of eravacycline. Novasep says it will continue to produce eravacycline in its facility in Chasse sur Rhône, France.