Aeterna Zentaris Forms Strategic Review Committee and Appoints Michael Ward as CEO
July 20 2017 - 5:00PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the
“Company”), announced today that it has formed a special committee
of independent directors (the “Strategic Review Committee”) to
consider and evaluate various strategic and financing alternatives
available to the Company to maximize shareholder value, including
continuing to execute on its existing business plan and/or
considering and recommending changes to the Company’s management
and governance. The Strategic Review Committee will be chaired by
Carolyn Egbert, and includes Michael Cardiff. The Strategic Review
Committee is in the course of engaging a financial advisor to
assist with this process. On July 18, the Company announced that it
has been notified by the U.S. Food and Drug Administration (“FDA”),
that the Company’s New Drug Application (“NDA”) seeking approval of
Macrilen™ (macimorelin) for the evaluation of growth hormone
deficiency in adults (“AGHD”) has been accepted as a complete
response to the FDA’s November 5, 2014 Complete Response Letter and
granted a PDUFA date of December 30, 2017. The Company has reached
an important point in its evolution and wishes to conduct a
strategic review of its plans, resources and opportunities, in
order to best position itself to maximize stakeholder value.
David A. Dodd has ceased to be the Company’s President and CEO
with immediate effect. The board of directors of the Company (the
“Board”) has appointed Michael Ward as the Company’s Chief
Executive Officer.
Mr. Ward has over thirty years of executive and legal experience
in the healthcare, pharmaceutical and technology industries. Most
recently, Mr. Ward served as Chief Compliance & Legal Officer
and Corporate Secretary for Sagent Pharmaceuticals (NASDAQ:SGNT), a
global specialty generic pharmaceutical company, and led its sale
to Nichi-Iko Pharmaceutical Co., Ltd. for $736 million. Mr. Ward
has served as Strategic Advisor to Benevolent Capital Partners for
the last five years and is currently a Partner with Outside GC LLC.
Prior to Sagent Pharmaceuticals, Mr. Ward was Vice President,
Assistant General Counsel of Global Compliance, Ethics &
Litigation and Chief Privacy Officer at CDK Global. Mr. Ward has
served in several executive roles and was responsible for business
development, compliance, legal and operational matters in the
healthcare, pharmaceutical and technology industries during his
career. Mr. Ward graduated from Albion College and Case Western
Reserve University Law School.
There can be no assurance that evaluation of strategic
alternatives will result in any transaction being pursued, entered
into or consummated. The Company does not intend to make
further comment in regard to this process except as required by
applicable securities laws or the policies of NASDAQ and the
Toronto Stock Exchange.
Advisors
The Strategic Review Committee has engaged Bennett Jones LLP as
its legal advisor and Bayfield Strategy, Inc. as its strategic and
communications advisor.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is an orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin has been granted orphan drug designation by the FDA for
diagnosis of AGHD. The Company owns the worldwide rights to this
patented compound and has significant patent protection left. The
Company’s U.S. composition of matter patent expires in 2022 and its
U.S. utility patent runs through 2027. The Company proposes,
subject to FDA approval, to market macimorelin under the tradename
Macrilen™.
About AGHD
AGHD affects approximately 75,000 adults across the U.S., Canada
and Europe. Growth hormone not only plays an important role in
growth from childhood to adulthood, but also helps promote a
hormonally-balanced health status. AGHD mostly results from damage
to the pituitary gland. It is usually characterized by a reduction
in bone mineral density, lean body mass, exercise capacity, and
overall quality of life as well as an increase of cardiovascular
risks.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel pharmaceutical
therapies. We are engaged in drug development activities and in the
promotion of products for others. We recently completed Phase 3
studies of two internally developed compounds. The focus of our
business development efforts is the acquisition of licenses to
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 non-U.S. 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 provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. 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 risks and uncertainties, many of which are discussed
under the caption “Key Information – Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”).
Such statements include, but are not limited to, statements about
the progress of our research, development and clinical trials and
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue our
research and development 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
(including whether or not the regulatory authorities will
definitively accept the Company’s conclusions regarding Macrilen™
and approve its registration following the Company’s re-submission
of an NDA for the product as described elsewhere in this press
release), 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, our ability to take advantage of business
opportunities in the pharmaceutical industry, our ability to
protect our intellectual property, and 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 securities commissions and the SEC
for additional information on risks and uncertainties. Given these
uncertainties and risk factors, readers are cautioned not to place
undue reliance on these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce 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 applicable law.
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Bayfield Strategy, Inc.1-844-226-3222 (North American
Toll Free Number)1-416-855-0238 (Outside North
America)info@bayfieldstrategy.com
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