Paratek Pharmaceuticals, Inc. (PRTK)

[Enterprising Investor]

European Medicines Agency COMP Recommends Positive Opinion on Orphan Medicinal Product Designation for NUZYRA® (omadacycline) for Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease (6/27/23)

BOSTON, June 27, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended a positive opinion for orphan medicinal product designation for NUZYRA® (omadacycline) for the treatment of nontuberculous mycobacterial (NTM) lung disease. The COMP opinion applies to all species of NTM, including Mycobacterium abscessus (MAB) and Mycobacterium avium complex (MAC).

Orphan designation in the European Union (EU) is granted by the European Commission within 30 days of a positive opinion being issued by the COMP. This designation will provide Paratek with protocol assistance for developing NUZYRA as an orphan medicine, 10 years market exclusivity once the medicine is on the market, data exclusivity, and the potential for fee reductions. Orphan designation is available to sponsors developing products intended to treat life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in the EU, and where treatment provides a significant benefit to those affected by the condition compared to available treatment or where no satisfactory treatment is available.

“The COMP positive opinion on the recommendation to grant orphan drug designation for NUZYRA in the treatment of NTM lung disease represents a meaningful development for patients in Europe with this rare, difficult-to-treat, and debilitating condition,” said Randy Brenner, chief development and regulatory officer of Paratek. “Paratek is eager to work with regulators in the EU to align on a development program that would bring NUZYRA forward to address the significant unmet need for novel NTM treatments, especially oral antibiotics.”

NUZYRA earned U.S. FDA orphan drug designation for the treatment of pulmonary NTM disease caused by MAC and MAB in August 2021 and Fast Track Designation in June 2022.

NTM is an orphan disease with limited approved therapies. Paratek’s scientific program exploring NUZYRA’s potential in the treatment of NTM includes an ongoing U.S. Phase 2b study -- the first randomized, placebo-controlled Phase 2b study of its kind -- in patients with NTM pulmonary disease caused by M. abscessus, as well as other studies ranging from in vitro to real-world evidence.

Today’s standard of care for NTM typically involves a combination of multiple antibiotics, many of which are not approved for this disease. Treatment can often be life-long in duration and complicated by long-term tolerability challenges and adverse events. Patients with NTM exhibit myriad symptoms including severe fatigue, fever, cough and shortness of breath.

Paratek is currently in discussions with potential partners to develop and commercialize NUZYRA in Japan and in Europe as a potential treatment for NTM.

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 once-daily antibiotic with both 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.

https://www.globenewswire.com/news-release/2023/06/27/2695236/33636/en/European-Medicines-Agency-COMP-Recommends-Positive-Opinion-on-Orphan-Medicinal-Product-Designation-for-NUZYRA-omadacycline-for-Treatment-of-Nontuberculous-Mycobacterial-NTM-Lung-Di.html