Aeterna Zentaris (AEZS) Receives Positive CHMP Opinion of Macimorelin for Diagnosis of Adult Growth Hormone Deficiency
November 19 2018 - 8:00AM
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), announced the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending a marketing authorization for macimorelin, an orally
available ghrelin agonist, for diagnosis of adult growth hormone
deficiency (AGHD). The recommendation will now be reviewed by the
European Commission.
“We are pleased with the CHMP’s positive opinion of macimorelin
for AGHD,” said Michael V. Ward, Chief Executive Officer of Aeterna
Zentaris.
Macimorelin is already approved by the Food and Drug
Administration (FDA) in the United States for diagnosing AGHD and
is commercially marketed as Macrilen™.
About AGHD
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.
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 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. On November 27, 2017 Aeterna
Zentaris announced that the Marketing Authorization Application
(MAA) for the use of Macrilen™ (macimorelin) for the evaluation of
AGHD was accepted by the European Medicines Agency (EMA) for
regulatory review. Aeterna Zentaris has licensed Macrilen™
(macimorelin) to a subsidiary of Strongbridge Biopharma plc 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, the litigation involving two of our former officers, or
other litigation, on our cash flow, results of operations and
financial position; any evaluation of potential strategic
alternatives to maximize potential future growth and stakeholder
value may not result in any such alternative being pursued, and
even if pursued, may not result in the anticipated benefits, 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.com843-900-3201
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