Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia
November 29 2021 - 9:00AM
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 6th 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 AndersonNabriva Therapeutics plcir@nabriva.com
For Media
Andrea GreifOgilvyandrea.greif@ogilvy.com914-772-3027
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