Paratek Announces First Milestone Towards Creating a U.S. Manufacturing Supply Chain for NUZYRA® (omadacycline) under BARDA Project BioShield Contract

Rhea-AI Summary

Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) announced the commercial availability of U.S.-produced NUZYRA® (omadacycline) tablets following a successful technology transfer. This marks a significant step towards establishing a U.S. supply chain for NUZYRA under the Project BioShield partnership with BARDA. The contract awarded by BARDA, valued at up to $304 million, supports the onshoring of NUZYRA's manufacturing and its development for treating pulmonary anthrax. The company is also conducting a Phase 2b study for NUZYRA in non-tuberculous mycobacterial disease, targeting a $1 billion market in the U.S.

Positive

• Commercial availability of NUZYRA tablets in the U.S. after successful technology transfer.
• Establishment of a U.S. supply chain for NUZYRA, enhancing manufacturing security and availability.
• BARDA contract valued at up to $304 million supports development and manufacturing of NUZYRA.

Negative

• None.

BOSTON, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announces the commercial availability of U.S.-produced NUZYRA® (omadacycline) tablets. This milestone follows a successful technology transfer by Paratek and its tablet manufacturing partners in the United States and Europe.

NUZYRA is the company’s broad-spectrum, novel antibiotic available in both intravenous and oral formulations.

Onshoring of the manufacturing process for the tablets is the first completed step in the technology transfer process, with the active pharmaceutical ingredient (API) for NUZYRA and 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 U.S. supply chain for NUZYRA under the Project BioShield public-private partnership 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.

“As supply chain interruptions continue to threaten availability of essential medicines, Paratek is advancing our efforts with BARDA to onshore the manufacturing of NUZYRA to the United States. Creating a U.S.-based supply chain for NUZYRA means we can ensure supply of this essential antibiotic for use in patients as the antimicrobial resistance (AMR) crisis continues,” said Randy Brenner, chief development and regulatory officer, Paratek. “We are excited to reach this first milestone towards creating a fully integrated manufacturing supply chain for NUZYRA on U.S. soil. We are grateful to BARDA, as well as our manufacturing partners, for their expertise and teamwork in completing this first milestone and important technology transfer.”

In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the U.S. onshoring and manufacturing security requirements, this contract supports the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax; all FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for 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 U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), 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 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 clinical studies for NTM and the potential addressable market for NTM. 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 is the significance of the U.S. production of NUZYRA tablets by Paratek (PRTK)?

The U.S. production of NUZYRA tablets indicates a successful technology transfer, crucial for establishing a secure domestic supply chain.

How much is the BARDA contract awarded to Paratek Pharmaceuticals (PRTK) worth?

The BARDA contract awarded to Paratek is valued at up to approximately $304 million.

What diseases is NUZYRA used to treat?

NUZYRA is used to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

What upcoming developments are planned for NUZYRA (PRTK) in the future?

Paratek plans to complete the onshoring of the active pharmaceutical ingredient (API) for NUZYRA by 2023 and NUZYRA vials by 2024.

What is the potential market for NUZYRA in non-tuberculous mycobacterial disease?

The addressable market for NUZYRA in treating non-tuberculous mycobacterial disease is estimated to be $1 billion in the U.S.