Aeterna Zentaris Announces Publication of GHD Management Guidelines
December 18 2019 - 9:00AM
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS)
is pleased to announce that the American Association of Clinical
Endocrinologists (AACE) and American College of Endocrinology (ACE)
have recently published the new ‘Guidelines for Management of
Growth Hormone Deficiency in Adults and Patients transitioning from
Pediatric to Adult Care’.
These AACE/ACE 2019 Guidelines (publicly
available at (https://journals.aace.com/doi/10.4158/GL-2019-0405)
identify macimorelin as a “shorter and simpler alternative”
compared to the traditionally available growth hormone stimulation
tests (GHSTs). For further details, refer to the text of the
guideline.
“Macimorelin is now in use within endocrine
practice in the United States, thereby highlighting the important
contribution of this product in the diagnosis of Growth Hormone
Deficiency (GHD),” commented Dr. Nicola Ammer, Chief Medical
Officer, Aeterna Zentaris, on the 2019 guidelines update. “This
encouraging news supports our belief in the strong capabilities of
macimorelin, and may improve its awareness and acceptance in the
broader marketplace,” commented Dr. Klaus Paulini, Chief Executive
Officer, Aeterna Zentaris.
Full citation:AMERICAN ASSOCIATION OF
CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY
GUIDELINES FOR MANAGEMENT OF GROWTH HORMONE DEFICIENCY IN ADULTS
AND PATIENTS TRANSITIONING FROM PEDIATRIC TO ADULT
CAREKevin C. J. Yuen, Beverly M. K. Biller, Sally
Radovick, John D. Carmichael, Sina Jasim, Kevin M. Pantalone, and
Andrew R. Hoffman
Endocrine Practice 2019 25:11,
1191-1232
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company engaged in commercializing novel
pharmaceutical therapies, principally through out-licensing
arrangements. Aeterna Zentaris is the licensor and party to a
license and assignment agreement with Novo Nordisk A/S to carry out
development, manufacturing, registration, regulatory, and supply
chain for the commercialization of Macrilen™ (macimorelin), which
is to be used in the diagnosis of patients with adult growth
hormone deficiency in the United States and Canada. In addition, we
are actively pursuing business development opportunities for
macimorelin in the rest of the world and to monetize the value of
our non-strategic assets.
Forward-Looking Statements
This press release contains forward-looking
statements (as defined by applicable securities legislation) 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 "will," "expects,"
"believes," "intends," "would," "could," "may," "anticipates," and
similar terms that relate to future events, performance, or our
results. Forward-looking statements involve known and unknown risks
and uncertainties, including those discussed in this press release
and in our Annual Report on Form 20-F, under the caption "Key
Information – Risk Factors" filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission. 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, our ability to
continue as a going concern dependent, in part, on the ability of
Aeterna Zentaris to transfer cash from Aeterna Zentaris GmbH to the
Canadian parent and U.S. subsidiary and secure additional
financing, our now heavy dependence on the success of Macrilen™
(macimorelin) and related out-licensing arrangements and the
continued availability of funds and resources to successfully
commercialize the product, our strategic review process, the
ability of the Special Committee to carry out its mandate, the
ability of Aeterna Zentaris to enter into out-licensing,
development, manufacturing and marketing and distribution
agreements with other pharmaceutical companies and keep such
agreements in effect, reliance on third parties for the
manufacturing and commercialization of Macrilen™ (macimorelin),
potential delay or termination of our pediatric clinical trial
program, potential disputes with third parties, leading to delays
in or termination of the manufacturing, development, out-licensing
or commercialization of our product candidates, or resulting in
significant litigation or arbitration, and, more generally,
uncertainties related to the regulatory process, our ability to
efficiently commercialize or out-license Macrilen™ (macimorelin),
the degree of market acceptance of Macrilen™ (macimorelin), our
ability to obtain necessary approvals from the relevant regulatory
authorities to enable us to use the desired brand names for our
product, the impact of securities class action litigation or other
litigation on our cash flow, results of operations and financial
position, our ability to take advantage of business opportunities
in the pharmaceutical industry, our ability to protect our
intellectual property, the potential of liability arising from
shareholder lawsuits and general changes in economic conditions.
Investors should consult our quarterly and annual filings with the
Canadian and U.S. securities commissions 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.
Contact:
Leslie AuldChief Financial OfficerAeterna
Zentaris Inc.IR@aezsinc.com(843) 900-3211
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