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

Rhea-AI Summary

Nabriva Therapeutics (NASDAQ: NBRV) announced that its partner, Sumitomo Pharmaceuticals (Suzhou), received acceptance for their new drug application (NDA) to market lefamulin in China for treating community-acquired pneumonia (CAP). This NDA was accepted by the Chinese Center for Drug Evaluation on November 23, 2021. Lefamulin is anticipated to be the first-in-class treatment for CAP patients in China. This marks the sixth global filing for lefamulin, with four previous approvals and two applications under review.

Positive

• Lefamulin NDA acceptance by Chinese regulatory authority indicates potential market entry.
• Lefamulin expected to be a first-in-class treatment for community-acquired pneumonia in China.
• This NDA represents the sixth global filing, showcasing international interest and progress.

Negative

• None.

DUBLIN, Ireland and FORT WASHINGTON, Pa., Nov. 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, announced today that its partner, Sumitomo Pharmaceuticals’ (Suzhou) Co., Ltd., new drug application (NDA) to market oral and intravenous (IV) formulations of lefamulin for the treatment of community-acquired pneumonia (CAP) in adults in mainland China has been accepted for review by the Chinese Center for Drug Evaluation (CDE), China’s regulatory authority, on November 23, 2021.

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

“We are working collaboratively with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., throughout the health authority review. This filing brings Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. one step closer to their goal of offering lefamulin to patients with CAP in China. This is the 6^th global filing for lefamulin. To date there have been 4 approvals and two applications pending review,” said Ted Schroeder, Chief Executive Officer 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 received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the ability of Nabriva Therapeutics to raise awareness of XENLETA and SIVEXTRO and drive top-line sales growth, the potential benefits to patients of SIVEXTRO and XENLETA, the market opportunity for SIVEXTRO and XENLETA, the availability of SIVEXTRO through major U.S. specialty wholesalers, the impact on Nabriva Therapeutics’ reported revenue from anticipated sales of SIVEXTRO, the sufficiency of its cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutic’s ability to comply with its obligations under its loan agreement with Hercules, Nabriva Therapeutic’s ability to maintain the conditions under the distribution agreement to exclusively distribute and promote SIVEXTRO, including its ability to maintain a commercial infrastructure sufficient to promote and distribute SIVEXTRO, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the SEC. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments may cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors

Kim Anderson
Nabriva Therapeutics plc
ir@nabriva.com

For Media

Andrea Greif
Ogilvy
andrea.greif@ogilvy.com
914-772-3027

FAQ

What is the significance of Nabriva's NDA acceptance for lefamulin in China?

The NDA acceptance indicates progress towards bringing a new, first-in-class treatment for community-acquired pneumonia to the Chinese market, potentially benefiting patients.

When was the NDA for lefamulin submitted?

The NDA was submitted to the Chinese Center for Drug Evaluation and accepted for review on November 23, 2021.

How many global filings has lefamulin had?

Lefamulin has had six global filings, with four approvals and two applications currently under review.

What is the partnership between Nabriva and Sumitomo regarding lefamulin?

Nabriva entered into an agreement with Sumitomo Pharmaceuticals for the development and commercialization rights for lefamulin in the greater China region.