Aeterna Zentaris Provides Update on Previously Disclosed Class Action Lawsuit
March 05 2018 - 6:45AM
Aeterna Zentaris Inc. (the “Company” or “Aeterna Zentaris”)
(NASDAQ:AEZS) and (TSX:AEZS) announced today that the United
States District Court for the District of New Jersey has granted a
motion for class certification in the previously disclosed class
action lawsuit against the Company and certain of its current and
former officers and directors in connection with statements made by
the defendants between August 30, 2011 and November 6, 2014,
regarding the safety and efficacy of Macrilen™ (macimorelin) and
the prospects for the approval of the Company's new drug
application for the product by the FDA. The Company continues
to believe that substantially all of the costs for its defense will
be borne by the insurers who provide directors' and officers'
liability insurance to the Company, subject to policy
limits.
While the Company believes that it has
meritorious defenses and intends to defend this lawsuit vigorously,
the Company cannot currently predict the outcome of this suit or
reasonably estimate any potential loss that may result from this
suit. Accordingly, the Company has not recorded any liability
related to the lawsuit. No assurance can be given with respect to
the ultimate outcome of such proceedings, and the Company could
incur substantial unreimbursed legal fees, damages, settlements,
judgments, and other expenses in connection with these proceedings
that may not qualify for coverage under, or may exceed the limits
of, the Company’s applicable directors' and officers' liability
insurance and could have a material adverse impact on the Company’s
financial condition, results of operations, liquidity and cash
flows.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company focused on developing and
commercializing, principally through out-licensing arrangements,
Macrilen™ (macimorelin), an orally available ghrelin agonist, to be
used in the diagnosis of patients with adult growth hormone
deficiency (AGHD). On January 17, 2018 Aeterna Zentaris announced
that that it had, through a wholly-owned subsidiary, entered into a
license and assignment agreement with a wholly-owned subsidiary of
Strongbridge Biopharma plc to carry out development, manufacturing,
registration and commercialization of Macrilen™ (macimorelin) in
the United States and Canada. On December 20, 2017 the Company
announced that the U.S. Food and Drug Administration (FDA) granted
marketing approval for Macrilen™ (macimorelin). On November 27,
2017 Aeterna Zentaris announced that the Marketing Authorization
Application (MAA) for the use of Macrilen™ (macimorelin) for the
evaluation of AGHD was accepted by the European Medicines Agency
(EMA) for regulatory review. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking
statements made pursuant to the safe-harbor provisions of the U.S.
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws, which reflect our current expectations regarding
future events. Forward-looking statements may include, but are not
limited to statements preceded by, followed by, or that include the
words “expects,” “believes,” “intends,” “would,” “could,” “may,”
“anticipates,” and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known risks and uncertainties, many of which are discussed under
the caption “Key Information - Risk Factors” in our most recent
Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”)
and under the caption “Risk Factors and Uncertainties” in our
management’s discussion and analysis for the third quarter of 2017.
Such statements include, but are not limited to, statements about
the merit or outcome of the class action lawsuit, the Company’s
intention and ability to defend such legal actions, and the
availability of insurance to cover costs and expenses relating to
the defense of the lawsuit. Known and unknown risks and
uncertainties could cause our actual results to differ materially
from those in forward-looking statements. Such risks and
uncertainties include, effect of the class action lawsuit and other
litigation, on our cash flow, results of operations and financial
position. Investors should consult the Company’s quarterly and
annual filings with the applicable Canadian securities regulators
and the SEC for additional information on risks and uncertainties.
Given these uncertainties and risk factors, readers are cautioned
not to place undue reliance on these forward-looking statements. We
disclaim any obligation to update any such factors or to publicly
announce any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments,
unless required to do so by a governmental authority or applicable
law.
Contacts:
Aeterna Zentaris Inc.Michael V. WardChief Executive
OfficerIR@aezsinc.com843-900-3201
Reilly ConnectSusan
ReillyPresidentsusan.reilly@reillyconnect.com312-600-6783
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