Aeterna Zentaris Receives European Marketing Clearance for Macimorelin
January 16 2019 - 9:03AM
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:
AEZS) announced that the European Medicines Agency
(EMA) has granted marketing authorization for macimorelin, an
orally available ghrelin agonist, for diagnosis of adult growth
hormone deficiency (AGHD). The approval came following the
Committee for Medicinal Products for Human Use (CHMP) positive
opinion of macimorelin on November 15, 2018.
“Clinical studies have demonstrated that macimorelin is
safer and much simpler to administer than the current methods of
testing for insulin-induced hypoglycemia, and is well-tolerated by
patients and reliable in diagnosing the condition,” said Dr.
Christian Strasburger, the Head of Clinical Endocrinology at
Charité Unversitaetsmedizin Berlin and the principal investigator
for macimorelin. “Both patients and healthcare-providers will
undoubtedly welcome the general availability of macimorelin and I
believe that macimorelin will become the generally accepted new
reference procedure for diagnosing adult growth hormone
deficiency.”
AGHD may occur in an adult subject who has a history of
childhood onset growth hormone deficiency (GHD) or may occur during
adulthood as an acquired condition. Considering a population of 510
million for the European Community, research based on incidence
prevalence suggests that at least 35,000 adults could be afflicted
with GHD.
“The EMA approval of macimorelin further validates the
value of the product and will assist in our efforts to create value
for our shareholders from macimorelin,” said Michael V. Ward, Chief
Executive Officer, Aeterna Zentaris.
About Macimorelin
Macimorelin stimulates the secretion of growth hormone from the
pituitary gland into the circulatory system.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company
focused on developing and commercializing, principally through
out-licensing arrangements, Macrilen™ (macimorelin), an oral
ghrelin receptor agonist, to be administered in the diagnosis of
patients with adult growth hormone deficiency. Aeterna Zentaris is
a party to a license and assignment agreement with a subsidiary of
Novo Nordisk A/S to carry out development, manufacturing,
registration and commercialization of Macrilen™ (macimorelin) in
the United States and Canada. For more information, visit
www.zentaris.com.
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 now heavy dependence on the success of
Macrilen™ (macimorelin) and related out-licensing arrangements and
the continued availability of funds and resources to successfully
launch the product, 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 our product candidates,
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 products, 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:
Michael V. WardChief Executive OfficerAeterna Zentaris
Inc.IR@aezsinc.com 843-900-3201
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