MMS Submission Support for Paratek Pharmaceuticals Garners FDA Approval and Successful MAA Filing of NUZYRA™ (Omadacycline)
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.”
This is the first and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 years. Paratek plans on making NUZYRA available in the first quarter 2019.
MMS has been partnering with Paratek for the past five years. Stay up-to-date with MMS at: www.linkedin.com/company/mms-holdings-inc-
About MMS Holdings
MMS is a global, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex regulatory submission challenges. As a data-focused CRO, we are pioneers and leaders in regulatory submissions for our sponsors. Strong industry experience and a data-driven approach to drug development make MMS a valuable partner in creating compelling submissions that meet rigorous regulatory standards. MMS was named Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow @mmsholdings on Twitter.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The company’s lead commercial product, NUZYRA, is a once-daily intravenous and oral antibiotic for the treatment of adult patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).
Paratek is also preparing a marketing authorization application for omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek’s second FDA approved product, SEYSARA™ (sarecycline), will be marketed by Almirall, SA in the U.S. as a new once-daily oral therapy for the treatment of acne. Paratek retains development and commercialization rights in the rest of the world.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Media contact
Avery Zimmerman
media@mmsholdings.com
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