Novasep and Paratek increase API manufacture for antibiotic
Technology supplier Novasep and Paratek Pharmaceuticals have signed an agreement to increase the commercial production of an active pharmaceutical ingredient (API) for an antibiotic.
The agreement will see Novasep and Paratek Pharmaceuticals working together to ramp up the commercial production of omadacycline, an API used for the oral and intravenous antibiotic NUZYRA and which is used to treat adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The agreement follows a 2016 partnership signed by Novasep and Paratek Pharmaceuticals in 2016, where the companies agreed to the 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. Significant investments have been made on this site to expand Novasep’s API production capacities. While production will continue at Chasse-sur-Rhône, the final step of the process will be conducted at Novasep’s Leverkusen site (Germany) starting in 2023 to address increased volume requirements.
“This deal marks a real recognition of the long-time expertise of the Novasep teams in the production of complex APIs, demonstrating the strength of our process development and the integration of specialist purification technologies such as HPLC chromatography,” said Jean Bléhaut, president of the Pharma Solutions Business Unit at Novasep. “We would like to thank Paratek for their support and trust throughout this project; we are proud to support them in delivering such an innovative drug to fight against the antimicrobial resistance for the benefit of patients.”
“This long-term agreement with Novasep in our existing supply chain helps ensure that Paratek can continue to confidently supply NUZYRA to meet the needs of patients and healthcare providers, fulfill our commitments to BARDA, and explore further opportunities to provide an innovative solution to the antimicrobial resistance crisis,” added Randy Brenner, Paratek’s chief development and regulatory officer. “We are grateful to our colleagues at Novasep for their continued partnership in manufacturing high quality API and securing our supply chain.”