QUEBEC CITY, Nov. 25, 2015 /PRNewswire/ - Aeterna
Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"),
affirms that its business and prospects remain fundamentally strong
and highlights the following developments:
- Zoptrex™ (zoptarelin doxorubicin) recently
received DSMB recommendation to continue the ZoptEC Phase 3
clinical program to completion following review of the final
interim efficacy and safety data
- Zoptrex™ met Phase 2 Primary Endpoint in men with
heavily pretreated castration- and Taxane-resistant prostate
cancer
- First patient enrolled in the confirmatory Phase 3 clinical
trial of Macrilen™
- Promotion of Saizen® and EstroGel® by
the Company's sales force continues to show promise
- Dilution from Series B Share Purchase Warrants has been
substantially eliminated
Commenting about the fundamentals of the Company's business,
Chairman, President and Chief Executive Officer David A Dodd
stated, "Yesterday's announcement regarding corporate developments,
which was required by IIROC on behalf of the Toronto Stock
Exchange, caused some to question the fundamentals of our
business. I want to reiterate that we believe the fundamentals
remain strong. We have two products in Phase 3. One of
the products, Zoptrex™, is in the late stage of Phase
3. We instituted a confirmatory Phase 3 clinical trial of
Macrilen™ after a panel of US and EU endocrinology
experts advised us to continue to seek approval for the compound
because of their confidence in its efficacy and because there
currently is no FDA-approved diagnostic test for adult growth
hormone deficiency. That Phase 3 study recently enrolled its
first patient, keeping us on track to conclude it by the end of
2016."
Mr. Dodd also commented on the Company's business development
efforts, saying "We continue discussions with others about adding
to our portfolio of promoted products and about the commercial
rights to and development of Zoptrex™ in markets
outside the United States. Of
course, our business is subject to the risks inherent in the
development of biopharmaceuticals. But we are successfully
moving forward with activities intended to create long-term value
for our shareholders. We are confident in our activities and
believe we are achieving the necessary progress to build
significant value for our shareholders, employees and the medical
providers and patients who will benefit from our developing
portfolio."
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. 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 US Securities
Litigation Reform Act of 1995. Forward-looking statements may
include, but are not limited to statements preceded by, followed
by, or that include the words "expects," "believes," "intends,"
"anticipates," and similar terms that relate to future events,
performance, or our results. The following statements in the
press release are forward-looking statements:
- The statement that the confirmatory Phase 3 clinical trial of
Macrilen™ is on track for completion by the end of
2016
- The statements regarding the success of the activities we are
undertaking in an effort to create long-term value for our
shareholders
Forward-looking statements involve known and unknown risks and
uncertainties that could cause the Company's actual results to
differ materially from those in the forward looking
statements. Such risks and uncertainties include, among
others, the availability of funds and resources to pursue R&D
projects and clinical trials, the successful and timely completion
of clinical studies, the risk that safety and efficacy data from
any of our Phase 3 trials may not coincide with the data analyses
from previously reported Phase 1 and/or Phase 2 clinical trials,
the ability of the Company to efficiently commercialize one or more
of its products or product candidates, the ability of the Company
to take advantage of business opportunities in the pharmaceutical
industry, uncertainties related to the regulatory process, the
ability to protect our intellectual property, the potential of
liability arising from shareholder lawsuits and general changes in
economic conditions. Investors should consult the Company's
quarterly and annual filings with the Canadian and US securities
commissions for additional information on risks and uncertainties
relating to forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements. The Company does not undertake to update these
forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce the result of 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 by applicable law.
SOURCE Aeterna Zentaris Inc.