|Paratek Pharmaceuticals Announces Positive Top Line Data from Pilot Efficacy Study for the Treatment of Pulmonary Anthrax and Acceptance of the Second Procurement of NUZYRA® (omadacycline) under BARDA Project BioShield|
BOSTON, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced positive top line data from a pilot rabbit efficacy study evaluating NUZYRA's effectiveness in the treatment of pulmonary anthrax. In the study, a 100% survival rate was observed in omadacycline-treated rabbits at the specified endpoint of 35-45 days post Bacillus anthracis (anthrax) challenge, while all rabbits treated with placebo died due to anthrax infection within three days.
Positive top line data from this study triggered the second procurement under the Company's Project BioShield Contract with Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Accordingly, Paratek has delivered 2,500 treatment courses of NUZYRA to BARDA. The acceptance of this procurement allows the Company to recognize $38.1 million in revenue, comprised of $36.4 million from BARDA and approximately $1.7 million in deferred revenue related to postmarketing commitments under the Project BioShield contract.
"This positive top line data represents further validation of NUZYRA's potential to treat pulmonary anthrax as well as the continued commitment by BARDA to our ongoing partnership," said Randy Brenner, chief development and regulatory officer, Paratek. "We believe that NUZYRA is well-positioned to help address potential public health emergencies, including biothreats and pandemics."
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.
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.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our BARDA contract, our performance under the BARDA contract, our potential to treat pulmonary anthrax, and NUZYRA's ability to help address potential public health emergencies, including biothreats and 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, 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.
|12/19/2022 7:30:00 AM