Paratek Announces First Milestone Towards Creating a US Manufacturing Supply Chain for NUZYRA® (omadacycline) Under BARDA Project BioShield Contract | So Good News
BOSTON, October 31 2022 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced the commercial availability of US-manufactured NUZYRA® (omadacycline) tablets. This milestone follows a successful technology transfer by Paratek and its tablet manufacturing partners in the US and Europe.
NUZYRA is an innovative antibiotic available in both intravenous and oral formulations.
This is the first step in the technology transfer process based on the manufacturing process for NUZYRA and tablets with active pharmaceutical ingredient (API) for NUZYRA vials scheduled to be completed in 2023 and 2024, respectively.
The commercial availability of NUZYRA tablets manufactured in the United States represents the first of several steps to create an end-to-end US supply chain for NUZYRA under Project BioShield, a public-private partnership under the Biomedical Advanced Research and Development Authority (BARDA). Part of strategic preparedness and response management within the US Department of Health and Human Services.
“As supply chain disruptions continue to threaten the availability of essential medicines, Paratek is advancing our efforts with BARDA to bring NUZYRA manufacturing onshore to the United States. Creating a US-based supply chain for NUZYRA can ensure the supply of essential antibiotics for use in patients,” said Randy Brenner, Paratek’s chief development and regulatory officer. “We are excited to reach this first milestone in creating a fully integrated manufacturing supply chain for NUZYRA on US soil. We thank BARDA and our manufacturing partners for their expertise and teamwork in completing this first milestone and important technology transfer.”
In December 2019, BARDA awarded the contract (75A50120C00001) to Paratek, now worth approximately $304 million. In addition to supporting US onshoring and production security requirements; This contract supports the development of NUZYRA for both the treatment and prevention of pneumonia. all FDA marketing requirements associated with initial NUZYRA approval; and procurement of up to 10,000 treatment courses of NUZYRA for anthrax.
Paratek Pharmaceuticals, Inc. About
Paratek Pharmaceuticals, Inc. is civil, A commercial-grade biopharmaceutical company that develops innovative life-saving therapies for government and military health threats or other public health threats.
The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI) in adults in the United States. ) 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 the rare disease non-tuberculous mycobacterial (NTM) lung disease. Mycobacterium abscessus It’s complicated. Paratek estimates that this opportunity represents a potential $1 billion addressable market in the United States.
Paratek has exclusively licensed the US rights and rights for the greater China territory to Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne, to Almirall, LLC. Paratek retains development and commercial rights to Sarecycline worldwide.
In 2019, Paratek was awarded a contract by the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to support the development of omadacycline for pulmonary anthrax and US-based pulmonary anthrax, now worth up to $304 million. Commercial manufacturing of NUZYRA.
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NUZYRA® (omadacycline) is an 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 modern tetracycline; NUZYRA is used to overcome tetracycline resistance and Gram-positive, gram-negative; Activity has been shown across a spectrum of bacteria, including atypicals and other drug-resistant strains.
Forward Looking Statements
This press release contains statements about our BARDA contract; Our performance under the BARDA contract; This press release contains forward-looking statements, including our clinical studies for NTM and potential addressable markets for NTM. All statements other than historical information contained in this press release are forward-looking statements. Identified by words such as “progressing,” “expecting,” “looking forward to,” “expecting,” “proceeding.” Other words and synonyms. These expectations are based on our current expectations and involve significant risks and uncertainties. We can actually implement plans; We may not be able to achieve the objectives or meet the hopes or expectations expressed in our forward-looking statements, and you should not place undue reliance on such forward-looking statements. Our actual results and timing of events may differ materially from those contained in forward-looking statements due to these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Form 10-K for the year ended December 31, 2021 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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