National Healthcare Security Administration Adds NUZYRA to NRDL for Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections
BOSTON, Jan. 18, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that China’s National Healthcare Security Administration (NHSA) has added the intravenous (IV) formulation of NUZYRA® (omadacycline) to the country’s National Reimbursement Drug List (NRDL) for treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), resulting in millions of patients gaining access to the broad-spectrum, once daily antibiotic.
“The addition of NUZYRA to China’s NRDL means millions of patients now benefit from increased accessibility to this life-saving therapy for serious community-acquired infections, said Evan Loh, M.D., Paratek chief executive officer. “This NRDL listing expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis. We are grateful to the NHSA for their recognition of the clinical benefit and compelling value proposition that novel, innovative antibiotics such as NUZYRA provide to patients. We also applaud our partner Zai Lab for their commitment to bringing NUZYRA to patients in China.”
NUZYRA was granted approval by the U.S. Food and Drug Administration in October 2018 and Paratek initiated the U.S. product launch in February 2019. Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.
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.
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 related to the inclusion of NUZYRA in China’s National Reimbursement Drug List, that such inclusion further validates the clinical efficacy and safety and value proposition of NUZYRA in treating community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections and that NUZYRA will play an important role in helping physicians address antimicrobial resistance in China. 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.