Aeterna Zentaris Announces IND Submission by Sinopharm A-Think
June 14 2016 - 5:00PM
Business Wire
Clinical Development Expected to Start in First Half of 2017
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
today announced that its licensee, Sinopharm A-Think
Pharmaceuticals Co., Ltd. (“Sinopharm A-Think”), which is
affiliated with the largest state-owned pharmaceutical company in
the People’s Republic of China, today submitted an Investigational
New Drug application (“IND”) for Zoptrex™ to the Chinese State Food
and Drug Administration (“CFDA”), remaining on track to commence
its clinical program during the first half of 2017.
The IND submission follows Sinopharm A-Think’s recent
implementation of the processes for manufacturing Zoptrex™, which
will enable it to commence its clinical program with product
manufactured locally. Dr. Richard Sachse, Senior Vice President and
Chief Medical and Scientific Officer of the Company, stated, “The
Company’s Frankfurt-based personnel assisted Sinopharm A-Think with
the IND by providing extensive information regarding the Chemistry,
Manufacturing and Controls related to the manufacture of Zoptrex™.
We are pleased that we were able to assist our licensee to achieve
this important step in their clinical development of Zoptrex™. I
remain very impressed by the progress that Sinopharm A-Think is
making.”
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. We are engaged in drug
development activities and in the promotion of products for others.
We are now conducting Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition or license of products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
territories where such out-licensing would enable us to ensure
development, registration and launch of our product candidates. Our
goal is to become a growth-oriented specialty biopharmaceutical
company by pursuing successful development and commercialization of
our product portfolio, achieving successful commercial presence and
growth, while consistently delivering value to our shareholders,
employees and the medical providers and patients who will benefit
from our products. 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. 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 rejection or non-acceptance of any new drug application
by one or more regulatory authorities and, more generally,
uncertainties related to the regulatory process, the ability of the
Company to efficiently commercialize one or more of its products or
product candidates, the degree of market acceptance once our
products are approved for commercialization, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160614006424/en/
Aeterna Zentaris Inc.Philip A. TheodoreSenior Vice
President843-900-3223ir@aezsinc.com
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