Aeterna Zentaris Reports on Zoptrex™ Development Progress in China
March 01 2016 - 8:30AM
Business Wire
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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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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