Law
Offices of Howard G. Smith announces that it is investigating
potential claims on behalf of investors of Aeterna Zentaris, Inc.
(“Aeterna Zentaris” or the “Company”) (NASDAQ:AEZS). The investigation
concerns possible violations of federal securities laws and focuses on
certain statements issued by Aeterna Zentaris concerning the Company’s
operations and business prospects.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in the
development and commercialization of novel treatments in oncology and
endocrinology. The investigation is related to the Company’s November 6,
2014, announcement that it has received a Complete Response Letter from
the U.S. Food and Drug Administration for Aeterna Zentaris’ New Drug
Application (NDA) for Macrilen™ (macimorelin), an orally-active ghrelin
agonist, for use in evaluating adult growth hormone deficiency.
According to the Company, the FDA’s review of the application has
determined that the NDA cannot be approved in its present form. Among
other things, the Complete Response Letter notes: (1) the planned
analysis of the Company’s pivotal trial did not meet its stated primary
efficacy objective as agreed to in the Special Protocol Assessment
agreement letter between the Company and the FDA; and (2), issues
related to the lack of complete and verifiable source data for
determining whether patients were accurately diagnosed with adult growth
hormone deficiency. In light of the failed primary analysis and data
deficiencies noted, the FDA concluded that “the clinical trial does not
by itself support the indication,” and the Company will need to
demonstrate the drug’s efficacy in a new, confirmatory clinical study.
If you purchased shares of Aeterna Zentaris, if you have information or
would like to learn more about these claims, or if you have any
questions concerning this announcement or your rights or interests with
respect to these matters, please contact Howard G. Smith, Esquire, of
Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem,
Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888)
638-4847, or by email to howardsmith@howardsmithlaw.com,
or visit our website at www.howardsmithlaw.com.
Copyright Business Wire 2014