Paratek Pharmaceuticals Announces Positive Top Line Data From Pilot Efficacy Study for the Treatment of Pulmonary Anthrax & Acceptance of the Second Procurement of NUZYRA Under BARDA Project BioShield

Paratek Pharmaceuticals, Inc. recently 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 US. 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.

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 US.

Paratek exclusively licensed US 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. For more information, visit www.ParatekPharma.com.