MMS announced their support to Paratek Pharmaceuticals for the new drug application (NDA) approval and successful marketing authorization application (MAA) filing of Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
Since being selected to support the US and EU submissions, MMS has assisted with integrated microbiology and safety analyses, authoring and QC of clinical summary documents, and preparation of all components for dispatch to regulatory authorities.
"MMS is proud to support such an important compound that has the potential to reduce the threat of antibiotic resistance," said Uma Sharma, Ph.D., Chief Scientific Officer, MMS. "Paratek's years of hard work, combined with our operational and thought leaders in regulatory submissions, provided a perfect pairing to ultimately bring this much-needed treatment to patients."
Prior to this submission support, MMS successfully supported Paratek's pivotal Phase 3 studies for the compound.
"A special thanks to this team for all the hard work and effort you put into hitting this important milestone for the company – this was nothing short of remarkable," said Randy Brenner, Senior Vice President Global Regulatory Affairs, Quality, and Technical Operations, Paratek. "This team never stopped working towards our deadline, and from day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market."