MMS Holdings Inc. (MMS) announced today that it was selected by Paratek Pharmaceuticals, Inc., (NASDAQ: PRTK) to support the development of its U.S. new drug applications (NDAs) for omadacycline. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Since its selection in June, MMS has been assisting in drafting, assembling and publishing the clinical components of the omadacycline NDAs for the U.S. Food and Drug Administration (FDA) in acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Omadacycline is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including ABSSSI, CABP, and urinary tract infections (UTI).
“We are excited to continue and expand our relationship with Paratek and are proud to be a vital part of supporting their NDA submission,” stated Uma Sharma, Chief Scientific Officer at MMS. “We routinely support NDAs, but the omadacycline NDAs are special given that it will be the first multi-indication (CABP and ABSSSI) antibiotic initial NDA submissions in over 10 years with both oral and IV formulations.”
“Over the last three years, MMS has successfully supported Paratek’s pivotal Phase 3 studies. MMS was an obvious choice to assist Paratek with the NDA given their programming, medical writing, and regulatory operations capabilities,” said Evan Tzanis, Senior Vice President, Clinical Development and Medical Affairs, Paratek.
MMS is a global clinical research organization that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex regulatory submission challenges. As a data CRO, we are the pioneers and leaders in regulatory submissions for our sponsors. Our strong industry experience and data-driven approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. For more information, please visit www.mmsholdings.com.
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 product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and is preparing to submit marketing applications in the United States and European Union. Paratek has licensed rights for omadacycline to Zai Lab for 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 Phase 3 product candidate, sarecycline, is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for sarecycline and is preparing a new drug application for submission to the U.S. Food and Drug Administration. Paratek retains all ex-U.S. rights to sarecycline.
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.