Paratek Pharmaceuticals Receives $36.4 Million Milestone Payment Associated with the Second Procurement of NUZYRA® (omadacycline) under BARDA Project BioShield Contract

Rhea-AI Summary

Paratek Pharmaceuticals reported $38.1 million in procurement-related revenue in December 2022, driven by a $36.4 million milestone payment from BARDA under Project BioShield. This funding supports the development of NUZYRA (omadacycline) for treating pulmonary anthrax, following positive efficacy study results showing a 100% survival rate in treated rabbits. The BARDA contract, now valued at approximately $304 million, will fund the procurement of up to 10,000 treatment courses of NUZYRA, enhancing its market position.

Positive

• Received $36.4 million milestone payment from BARDA.
• Total revenue recognition of $38.1 million in December 2022.
• Positive results from pilot efficacy study showing 100% survival rate in treated rabbits.

Negative

• None.

• Total Procurement-related Revenue Recognition of $38.1 Million to Paratek in December 2022
• Procurement Triggered by Positive Top-Line Data from Pilot Efficacy Study of NUZYRA for the Treatment of Pulmonary Anthrax Announced in December
  

BOSTON, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced the receipt of a $36.4 million milestone payment associated with the second procurement of NUZYRA^® (omadacycline) under the company’s Project BioShield contract with the 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.

A total of $38.1 million in procurement-related revenue was recognized by the company in December 2022 and is comprised of $36.4 million from BARDA and approximately $1.7 million in deferred revenue related to post-marketing commitments under the Project BioShield contract.

The delivery of 2,500 anthrax treatment courses of NUZYRA to BARDA followed the company’s previous announcement of positive top-line results from a pilot rabbit efficacy study evaluating NUZYRA’s effectiveness in the treatment of pulmonary anthrax. The study demonstrated a 100% survival rate in all three dose groups of omadacycline-treated rabbits at the specified endpoint of 45 days post Bacillus anthracis (anthrax) challenge, while all rabbits treated with placebo died due to anthrax infection within three days. These data will be presented at a future scientific congress.

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.

For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. 

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.

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. 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.

CONTACTS:
For Investors:
Hans Vitzthum
LifeSci Advisors
Ir@ParatekPharma.com
617-430-7578

For Media:
Christine Fanelle
Scient PR
Christine@ScientPR.com
215-595-5211

FAQ

What was the total revenue recognized by Paratek in December 2022?

Paratek recognized a total of $38.1 million in revenue in December 2022.

What milestone payment did Paratek receive from BARDA?

Paratek received a $36.4 million milestone payment from BARDA.

What are the results of the efficacy study for NUZYRA?

The efficacy study for NUZYRA showed a 100% survival rate in all treated rabbit dose groups.

What is the value of Paratek's contract with BARDA?

The contract with BARDA is now valued at approximately $304 million.

How many treatment courses of NUZYRA are included in the BARDA contract?

The BARDA contract supports the procurement of up to 10,000 treatment courses of NUZYRA.