Novasep and Paratek enhance collaboration to produce Nuzyra

French pharma ingredients company Novasep and USA-based Paratek Pharmaceuticals (Nasdaq: PRTK) have signed an agreement to ramp up the commercial production of omadacycline, the active pharmaceutical ingredient (API) used for Paratek’s Nuzyra.

In October 2018, the US Food and Drug Administration approved Nuzyra for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).

This agreement, which covers the commercial manufacturing of the API, is the result of a partnership started in 2016 with technical transfer and process development at Novasep’s Boothwyn site (USA, Pennsylvania). The process was then transferred to Novasep’s Chasse-sur-Rhône facility (France) for further scale-up, validation & cGMP manufacturing, leveraging Novasep’s large scale HPLC chromatography and synthesis capabilities.