Paratek Pharmaceuticals Announces Modification of BARDA Contract to Advance the Development of NUZYRA® (omadacycline) for Post-Exposure Prophylaxis (PEP) and Treatment of Pulmonary Anthrax
-- Third procurement to be split into two procurements based on the achievement of specific anthrax development milestones
-- Next procurement expected in early 2024
BOSTON, July 10, 2023 (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 and other public health threats for civilian, government and military use, today announced a modification to its Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The modification provides new development milestones associated with the achievement of specific anthrax development milestones for the next BARDA procurement of NUZYRA® (omadacycline).
BARDA and Paratek have agreed the next procurement of NUZYRA anthrax treatment courses will be split into two equal procurements based on the achievement of specific development milestones toward both treatment and post-exposure prophylaxis (PEP) indications of pulmonary anthrax.
The first of these procurements will be triggered by the delivery of positive top-line data from a dose-ranging efficacy study for PEP of inhalation anthrax in non-human primates (NHPs). The company expects this data to be available in the first quarter of 2024. The second of these procurements will be triggered by BARDA’s receipt of positive top-line data from a combination of two studies, a dose-ranging efficacy study in NHPs and a pivotal efficacy study in rabbits for the treatment of inhalation anthrax, which the company anticipates could be available as early as the fourth quarter of 2024. The trigger for the final procurement of NUZYRA continues to be Paratek’s receipt of sNDA approval from the FDA for the treatment of inhalation anthrax. The company will provide further specificity on these timelines as the anthrax development program progresses.
“We thank BARDA for the continued funding of our comprehensive NUZYRA development program for PEP and treatment of pulmonary anthrax and are pleased to announce these important contract modifications to further build on our promising in vitro and in vivo animal data generated to date,” said Randy Brenner, Paratek’s chief development and regulatory officer. “Our anthrax program remains vitally important since antimicrobial resistance and bioterrorism continue to be public health and national security risks.”
In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for treatment of anthrax.
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.
The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, now valued at up to $304 million, to support the development of omadacycline for pulmonary anthrax and the U.S.-based commercial manufacturing of NUZYRA.
For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.
About NUZYRA
NUZYRA (omadacycline) is a novel once-daily antibiotic with both 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.
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward-Looking Statements
This press release contains forward-looking statements including statements related to our overall BARDA contract, our execution under the contract, and potential utility of NUZYRA to address potential health emergencies, including pandemics. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2022 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
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