Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia



DUBLIN, Ireland and FORT WASHINGTON, Pa., November 29, 2021 (GLOBE NEWSWIRE) – Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that its partner Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. China was accepted for review by the China Center for Drug Evaluation (CDE), China’s regulatory authority, on November 23, 2021.

In May 2021, Nabriva entered into an agreement for the rights to develop and commercialize lefamulin in the greater Chinese region with Sumitomo Pharmaceuticals (Suzhou), the Chinese subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Lefamulin, once approved, is expected to become a new first-class treatment for Chinese patients with CAP.

“We are working in conjunction with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., throughout the health authority review. This case brings together Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. of their goal of offering lefamulin to patients with CAP in China. It’s the 6e global depot of defamulin. To date, there have been 4 approvals and two pending review requests, ”said Ted Schroeder, CEO of Nabriva Therapeutics.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has received approval from the United States Food and Drug Administration for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic antibiotic based on pleuromutilin for the treatment of community-acquired bacterial pneumonia (CAP). Nabriva Therapeutics is also developing CONTEPO ™ (fosfomycin) for injection, a first-class epoxy antibiotic with potential for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva has entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, NJ, USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

Forward-looking statements

All statements in this press release regarding Nabriva Therapeutics ‘future expectations, plans and prospects, including, but not limited to, statements about Nabriva Therapeutics’ ability to raise awareness of and stimulate XENLETA and SIVEXTRO sales growth, potential patient benefits of SIVEXTRO and XENLETA, market opportunity for SIVEXTRO and XENLETA, availability of SIVEXTRO through leading US specialty wholesalers, impact on revenues reported by Nabriva Therapeutics anticipated sales of SIVEXTRO, the adequacy of its liquidity and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “Plan”, “foresee”, “plan”, “target”, “potential”, “likely”, “will”, “would”, “could”, “should”, “continue” and similar expressions, constitute declaration ns forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those shown Third forward-looking statements due to various important factors, including: the ability of Nabriva Therapeutic to comply with its obligations under its loan agreement with Hercules, the ability of Nabriva Therapeutic to maintain the terms of the distribution agreement to distribute and promote SIVEXTRO exclusively, including its ability to maintain sufficient commercial infrastructure to promote and distribute SIVEXTRO, the extent of interruptions in activity resulting from the infection causing the COVID-19 epidemic or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional funding on an acceptable basis terms or not at all and other important factors as stated in the annual reports and t quarterly reports from Nabriva Therapeutics and other documents filed with the SEC. In addition, the forward-looking statements included in this press release represent the views of Nabriva Therapeutics as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments could change its point of view. However, although Nabriva Therapeutics may choose to update these forward-looking statements at some time in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be taken as representing the views of Nabriva Therapeutics as of a date subsequent to the date of this press release.


For investors

Kim anderson
Nabriva Therapeutics plc
[email protected]

For the media

Andrea Greif
[email protected]



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