XENLETATM (lefamulin) Announcement
On May 29, 2020, Nabriva Therapeutics plc (the “Company”)
announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted
a positive opinion recommending approval of XENLETA for the treatment of community-acquired pneumonia (“CAP”) in adults
when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP
or when these have failed.
The full text of the press release announcing the CHMP’s
opinion to recommend approval of XENLETA is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
CONTEPO New Drug Application
As previously reported,
in April 2019, the U.S. Food and Drug Administration (the “FDA”) issued a Complete Response Letter to the Company
in connection with its new drug application (“NDA”) for CONTEPO, the Company’s product candidate for the treatment
of complicated urinary tract infections, including acute pyelonephritis, stating that it was unable to approve the application
in its current form. Specifically, the Complete Response Letter requested that the Company address issues related to facility
inspections and manufacturing deficiencies at its active pharmaceutical ingredient contract manufacturer prior to the FDA approving
the NDA. In December 2019, the Company resubmitted the NDA for CONTEPO. The FDA accepted its application and scheduled the Prescription
Drug User Fee Act (“PDUFA”) date for June 19, 2020. The Company has been informed by the FDA that, in connection with
its review of the NDA for CONTEPO, the FDA will need to inspect the facilities of its third-party manufacturers in Europe. However,
on March 10, 2020, the FDA announced that it would restrict travel of its employees to Europe for inspections as a result of the
spread of COVID-19. As a result of these travel restrictions, the Company believes there is a substantial likelihood that the
FDA will not be able to complete its review of the Company’s NDA for CONTEPO prior to the PDUFA date. If the FDA cannot
complete its review of the NDA because of the current travel restriction or otherwise, or if the manufacturing issues that the
FDA previously identified are not resolved to the FDA’s satisfaction prior to the PDUFA date, the FDA may issue a Complete
Response Letter in response to the Company’s resubmitted NDA for CONTEPO and the Company may be further delayed in obtaining
or ultimately be unable to obtain regulatory approval of CONTEPO.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about
future expectations, plans and prospects for the Company, including but not limited to statements about the potential outcome
of and timing of a decision by the European Commission with respect to regulatory approval for XENLETA in Europe, the
development of CONTEPO for complicated urinary tract infections (“cUTIs”), the clinical utility of XENLETA for
CABP and of CONTEPO for cUTIs, plans for and timing of the review of regulatory filings for CONTEPO and XENLETA, efforts to
bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and/or CAP and
CONTEPO for cUTIs, the sufficiency of the Company’s existing cash resources and its expectations regarding anticipated
revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations 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: the content and timing of decisions made by the European Commission, the U.S. Food and Drug Administration and
other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and
timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications
will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical
trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of
cUTI, the ability to retain and hire key personnel, the extent of business and other interruptions resulting from the
infection causing the COVID-19 outbreaks or similar public health crises, the sufficiency of cash resources and need for
additional financing and such other important factors as are set forth in the Company’s annual and quarterly reports
and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements
included in this Form 8-K represent the Company’s views as of the date of this Form 8-K. The Company anticipates that
subsequent events and developments will cause its views to change. However, while the Company 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 the Company’s views as of any date subsequent to
the date of this Form 8-K.