Aeterna Zentaris Announces FDA Approval of Macrilen™ (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
December 20 2017 - 5:00PM
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), a specialty
biopharmaceutical company engaged in developing and commercializing
pharmaceutical therapies, announced today that the U.S. Food and
Drug Administration (FDA) has granted marketing approval for
Macrilen™ (macimorelin), an orally available ghrelin agonist, to be
used in the diagnosis of patients with adult growth hormone
deficiency (AGHD). The Company estimates that approximately 60,000
tests for suspected AGHD are being conducted each year across the
United States, Canada and Europe.
“Aeterna Zentaris is proud of our commitment to
patients with suspected AGHD and to the endocrinology community who
we are confident will welcome an easier safe and effective oral
diagnostic tool,” said Michael V. Ward, Chief Executive Officer,
Aeterna Zentaris. “In the absence of an FDA-approved diagnostic
test for AGHD, Macrilen™ fills an important gap and addresses a
medical need for a convenient test that will better serve patients
and health providers.”
Macrilen™ (macimorelin) stimulates the secretion
of growth hormone from the pituitary gland into the circulatory
system. Stimulated growth hormone levels are measured in four blood
samples over ninety minutes after oral administration of Macrilen™
(macimorelin) for the assessment of growth hormone deficiency
(“GHD”). Prior to the approval of Macrilen™ (macimorelin), the
historical gold standard for evaluation of AGHD was the insulin
tolerance test (“ITT”), an intravenous test requiring many blood
draws over several hours. The ITT procedure is inconvenient
for patients and medical practitioners and may contraindicate in
patients, such as those with coronary heart disease or seizure
disorder, because it requires the patient to experience
hypoglycemia to obtain an accurate result.
“Clinical studies have demonstrated that growth
hormone stimulation testing for AGHD with oral Macrilen™
(macimorelin) is reliable, well-tolerated, reproducible, safe and a
much simpler test to conduct than currently available options,”
said Kevin Yuen, MD, clinical investigator and
neuroendocrinologist, Barrow Neurological Institute, and medical
director of the Barrow Neuroendocrinology Clinic, Phoenix, Arizona.
“The availability of Macrilen™ (macimorelin) will greatly relieve
the burden of endocrinologists in reliably and accurately
diagnosing AGHD.”
Aeterna Zentaris intends to make Macrilen™
(macimorelin) available commercially in the United States during
the first quarter of 2018.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company focused on developing and commercializing
Macrilen™ (macimorelin). 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. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking
statements made pursuant to the safe-harbor provisions 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 (“SEC”).
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™ (macimorelin) and the
continued availability of funds and resources to successfully
launch the product, and, more generally, uncertainties related to
the regulatory process, the rejection of the MMA by the EMA and the
ability of the Company to efficiently commercialize 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 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 securities regulators 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.
Contacts:
Aeterna Zentaris Inc.Michael V. WardChief Executive
OfficerIR@aezsinc.com843-900-3201
Reilly ConnectSusan
ReillyPresidentsusan.reilly@reillyconnect.com312-600-6783
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