BOSTON, April 02, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study. The reimbursement cost for these post-marketing commitments is projected to total approximately $77 million.
In connection with the FDA approval of NUZYRA in October 2018, the FDA required that Paratek complete post-marketing pediatric studies examining the safety and efficacy of NUZYRA in children ages eight to 17 years. This includes a pharmacokinetic study as well as safety studies in children with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The FDA also required Paratek conduct an additional safety and efficacy study in adults with CABP. Finally, the FDA required a five?year post?marketing bacterial surveillance study, which is mandatory for all newly approved antibiotics.
“We are eager and well-prepared to conduct these studies, which will now be funded entirely through the BARDA Project BioShield public-private partnership award. The clinical and microbiologic data from these studies will augment the wealth of existing data examining the safety and efficacy of once-daily, oral and intravenous NUZYRA in life-threatening community acquired infections,” said Evan Loh, M.D., CEO, Paratek. “We are grateful for BARDA’s significant investment and their shared commitment to fighting antimicrobial resistance and ensuring that life-saving antibiotics are available to the patients who need them.”
In December 2019, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, awarded Paratek a five-year contract, valued at up to $285 million, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; 3) U.S. onshoring and manufacturing security requirements and 4) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
Under the terms of the contract that are now initiated, reimbursement has begun for all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval.
Paratek Statement on COVID-19
We applaud the heroic efforts of medical professionals around the world who are working to protect public health and combat the COVID-19 pandemic. Whether directly treating patients impacted by the virus or implementing containment measures to constrain its transmission, you selflessly put the needs and journey of your patients first.
We at Paratek will strive to do our part during this crisis. The safety of or employees, the healthcare community and payers is paramount. We are taking appropriate steps to protect our employees, healthcare community and payers, following all local and federal requirements, and continually monitoring the situation to provide the appropriate guidance. Paratek has embraced the public health guidance regarding social distancing with all employees now working from home, utilizing a virtual model for meetings and interactions with the healthcare community and payers.
As the global COVID-19 pandemic continues to evolve, to date we have been able to provide an uninterrupted supply of our commercially available antibiotic, NUZYRA®. Based on current inventory levels and expected demand, we do not currently anticipate a shortage of NUZYRA.
Due to the demands on the healthcare system during this unprecedented crisis with COVID-19, the recruitment of our ongoing clinical studies has been paused. At the current time, the only study currently recruiting is our oral only pharmacokinetic study in patients with pneumonia. As the study has not yet completed recruitment, the study will take longer than anticipated. As the situation evolves, we intend to provide future updates on timing of the initiation of recruitment and completion of the study.
About NUZYRA
NUZYRA• (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.
