Aeterna Zentaris’ Marketing Authorization Application for Macrilen™ (macimorelin) for Evaluation of Adult Growth Hormone ...
November 27 2017 - 4:41PM
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) announced that the
Marketing Authorization Application (“MAA”) for the use of
Macrilen™ (macimorelin) for the evaluation of adult growth hormone
deficiency (“AGHD”) has been accepted by the European Medicines
Agency (“EMA”) for regulatory review.
“Our goal is to relieve the burden of AGHD testing for
physicians worldwide and most importantly for patients and the
EMA’s acceptance of our MAA brings us closer to achieving that,”
said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris.
“Our vision is to see that Macrilen™ becomes the future for AGHD
management and the drug that endocrinologists and their staffs come
to depend on as the preferred test for patients seeking
answers.”
AGHD affects approximately 75,000 adults across the US, 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.
Macrilen™, an orally available ghrelin agonist, stimulates the
secretion of growth hormone from the pituitary gland. Stimulated
growth hormone levels are measured in blood samples after oral
administration of Macrilen™ for the assessment of growth hormone
deficiency (GHD).
“We believe that macimorelin can be a game changer for the
endocrinology community,” said Dr. Richard Sachse, M.D., Ph.D., the
company’s Senior Vice President, Chief Medical Officer and Chief
Scientific Officer. “It is the first innovation in adult GHD
testing in over 50 years and we hope it will eliminate the agony of
current standards of testing which require physician-supervised
administration and up to double digital patient blood draws over
several hours, thus providing a significant reduction of the
testing burden.”
On March 7, 2017, the Pediatric Committee of the EMA agreed to
the company’s Pediatric Investigation Plan (“PIP”) for Macrilen™, a
prerequisite for filing an MAA for any new medicinal product in
Europe. The EMA also agreed that the company may defer conducting
the PIP until after it filed a MAA for the use of Macrilen™ in
AGHD. The start of the EMA review procedure for the MAA has now
been confirmed by EMA as November 23, 2017.
About Macrilen™ (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 United
States Food and Drug Administration (“FDA”) for diagnosis of
AGHD. The company has a December 30, 2017 Prescription Drug
User Fee Act (PDUFA”) date on its NDA for Macrilen™.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company
focused on developing and commercializing Macrilen™. It recently
resubmitted an NDA to the FDA seeking approval of Macrilen™, an
internally developed compound, and was granted a December 30, 2017
PDUFA date by the FDA. 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 and applicable Canadian securities
laws, 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,” “would,” “could,” “may,”
“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. Such
statements include, but are not limited to, statements about the
timing of, and prospects for, regulatory approval and
commercialization of our product candidates, 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, our now heavy
dependence on the success of Macrilen™ and the continued
availability of funds and resources to successfully launch the
product in the event the FDA approves Macrilen™, the rejection or
non-acceptance of the NDA by one or more regulatory authorities
and, more generally, uncertainties related to the regulatory
process, the ability of the Company to efficiently commercialize
Macrilen™, the degree of market acceptance of Macrilen™ in the
event it is approved for commercialization by the FDA, 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 former officers of the Company, 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 the Company’s
quarterly and annual filings with the applicable 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.
Contacts:
Aeterna Zentaris Inc.Michael V. WardChief Executive
OfficerIR@aezsinc.com843-900-3223
Reilly ConnectSusan
ReillyPresidentsusan.reilly@reillyconnect.com312-600-6783
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