European Medicines Agency COMP Recommends Positive Opinion on Orphan Medicinal Product Designation for NUZYRA® (omadacycline) for Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease
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.
Forward-Looking Statements
This press release contains forward-looking statements including statements about our expectations regarding NUZYRA's potential utility to meet the unmet need in NTM, the significance of the orphan designation in Europe, and the potential market opportunity of 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, 2022 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.
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