Clinical Development Expected to Start in 2016
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, is on track to
submit a Clinical Trial Application (“CTA”) for Zoptrex™ to the Chinese
State Food and Drug Administration (“SFDA”) in the Summer of 2016 and
anticipates initiating the clinical development program later this year.
In addition, Sinopharm A-Think has successfully implemented the
technology processes and is preparing to manufacture the compound.
Dr. Richard Sachse, Senior Vice President and Chief Medical and
Scientific Officer of the Company, stated, “We are pleased with the
progress that Sinopharm A-Think is making in their efforts to develop
and commercialize Zoptrex™ in China. It has only been a little over a
year since we entered into our technology transfer and license
agreements with this important development partner. In that short period
of time, they have achieved tremendous strides toward implementing the
processes necessary to manufacture Zoptrex™ in China.”
Sinopharm A-Think is required to provide extensive information regarding
the Chemistry, Manufacturing and Controls related to the manufacture of
Zoptrex™ as part of the CTA. The Company’s Frankfurt-based personnel are
assisting Sinopharm A-Think to prepare this part of the CTA, by
providing additional characterization of reference standards over and
above what is required for an IND in the US and the EU, as well as
shipment of such standards to China. While preparing the CTA, Sinopharm
A-Think is also planning to manufacture sufficient quantities of
Zoptrex™ to support its clinical program.
Mr. Yadong Zheng, Chief Executive Officer of Sinopharm A-Think, added,
“We are very excited about and committed to the development of Zoptrex™
for our territories of China, Hong Kong and Macao. This development
program represents our priority focus in our portfolio development
activities and we look forward to a successful clinical development,
followed by registration and commercialization of Zoptrex™ by our
company. We also anticipate additional developments in further areas of
cancer therapy, working in close collaboration with Aeterna Zentaris.”
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 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.
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