Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company developing and
commercializing a diversified portfolio of pharmaceutical and
diagnostic products, today announced that Ghryvelin™ (macimorelin),
the first oral test approved for diagnosing Growth Hormone
Deficiency in adults (AGHD), is now available to healthcare
professionals across Europe (subject to reimbursement). This
availability is possible thanks to Aeterna’s licensing partner,
Consilient Health, Ltd. (“CH” or “Consilient Health”), a privately
owned pharmaceutical company focused on commercializing medicines
in Europe and Middle East.
“The development of innovative new medical
products is an intensive and rigorous process, so the European
launch of Ghryvelin™ is a significant milestone for both companies
as well as a positive development for patients who require AGHD
testing,” said Dr. Klaus Paulini, Chief Executive Officer of
Aeterna Zentaris. “The ability to bring to market an oral,
well-tolerated and time-efficient alternative to commonly used
labor-intensive tests to diagnose AGHD is a great accomplishment.
We are grateful for our partnership with Consilient Health, their
demonstrated leadership and expertise, and ability to expand the
international reach for macimorelin.”
AGHD is most often acquired from a pituitary
tumor or trauma to the brain but may also be idiopathic. It is
characterized by a number of variable symptoms including reduced
energy levels, altered body composition, osteoporosis (reduced bone
mineral density), reduced muscle strength, lipid abnormalities such
as increased LDL cholesterol, insulin resistance, and impaired
cardiac function. Treatment for GHD requires daily injections of
recombinant human growth hormone (rHGH).1
Ghryvelin™, a ghrelin agonist, is an orally
active small molecule that stimulates the secretion of growth
hormone from the pituitary gland. Stimulated growth hormone levels
are measured in blood samples after oral administration of
Ghryvelin™ for the assessment of AGHD. Please see Summary of
Product Characteristics for full prescribing information.2
European approval of Ghryvelin™ was granted in
2019, based on Phase 3 data showing that oral macimorelin provides
accuracy comparable to that of standard insulin tolerance testing
(ITT), but has a considerably more favorable safety profile
compared to ITT. Oral Ghryvelin™ also reduces false positive test
results, helping to avoid unnecessary treatment of patients.3
Aeterna’s licensing partner, Novo Nordisk is
currently marketing macimorelin in the United States under the
tradename Macrilen™.
About Consilient Health
Established in 2005 with headquarters in
Ireland, Consilient Health is an independent, dynamic and rapidly
growing pharmaceutical company with a rich heritage of
commercialising products in complex markets in therapeutic areas
such as women’s health, urology and endocrinology. The company has
a strategy of partnering with innovative companies to bring to
medicines to market that serve a clear unmet clinical need. In
November 2020 Consilient Health acquired the marketing rights from
Aeterna Zentaris to market Ghryvelin™ across EU and UK.
About
Macimorelin
Macimorelin, is the only U.S. FDA and European
Commission approved oral test indicated for the diagnosis of adult
growth hormone deficiency (AGHD). Macimorelin is currently marketed
in the United States under the tradename Macrilen™, through a
license and assignment agreement with Novo Nordisk and in Europe
and the United Kingdom under the tradename Ghryvelin™, through a
license agreement with Consilient Health, Ltd.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty
biopharmaceutical company developing and commercializing a
diversified portfolio of pharmaceutical and diagnostic products
focused on areas of significant unmet medical need. The Company's
lead product, macimorelin (Macrilen™; Ghryvelin®), is the first and
only U.S. FDA and European Commission approved oral test indicated
for the diagnosis of adult growth hormone deficiency (AGHD). The
Company is leveraging the clinical success and compelling safety
profile of macimorelin to develop it for the diagnosis of
childhood-onset growth hormone deficiency (CGHD), an area of
significant unmet need, in collaboration with Novo Nordisk.
Aeterna Zentaris is dedicated to the development
of therapeutic assets and has recently taken steps to establish a
growing pre-clinical pipeline to potentially address unmet medical
needs across a number of indications, including neuromyelitis
optica spectrum disorder (NMOSD), Parkinson's disease (PD),
hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou
Gehrig's disease). Additionally, the Company is developing an oral
prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and
Chlamydia trachomatis.
For more information, please visit
www.zentaris.com and connect with the Company on Twitter, LinkedIn
and Facebook.
Forward-Looking Statements
This press release contains statements that may
constitute forward-looking statements within the meaning of U.S.
and Canadian securities legislation and regulations and such
statements are made pursuant to the safe-harbor provision of the
U.S. Securities Litigation Reform Act of 1995. Forward-looking
statements are frequently, but not always, identified by words such
as "expects," "anticipates," "believes," "intends," "potential,"
"possible," and similar expressions. Such statements, based as they
are on current expectations of management, inherently involve
numerous risks, uncertainties and assumptions, known and unknown,
many of which are beyond our control. Forward-looking statements in
this press release include, but are not limited to, those relating
to: expectations regarding the commercialization of Ghryvelin™ and
any future plans with respect to the development of macimorelin for
CGHD.
Forward-looking statements involve known and
unknown risks and uncertainties, and other factors which may cause
the actual results, performance or achievements stated herein to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
information. Such risks and uncertainties include, among others,
results from ongoing or planned pre-clinical studies of our
products under development may not be successful or may not support
advancing the product to human clinical trials; our ability to
raise capital and obtain financing to continue our currently
planned operations; our now heavy dependence on the success of
macimorelin (sold under the trade names Macrilen® in the United
States and Ghryvelin™ in the EU) and related out-licensing
arrangements and the continued availability of funds and resources
to successfully commercialize the product, including our heavy
reliance on the success of the license agreement and the amended
license agreement (collectively the Novo Amended License Agreement)
and our license agreement with Consilient Health; the global
instability due to the global pandemic of COVID-19 and the war in
Ukraine and the resulting geopolitical instability, and its unknown
potential effect on our planned operations; our ability to enter
into out-licensing, development, manufacturing, marketing and
distribution agreements with other pharmaceutical companies and
keep such agreements in effect; and our ability to continue to list
our common shares on the NASDAQ. Investors should consult our
quarterly and annual filings with the Canadian and U.S. securities
commissions for additional information on risks and uncertainties,
including those risks discussed in our Annual Report on Form 20-F,
under the caption "Risk Factors". Given the 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.
No securities regulatory authority has either
approved or disapproved of the contents of this news release. The
Toronto Stock Exchange accepts no responsibility for the adequacy
or accuracy of this release..
Investor Contact:
Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
1 Pituitary Foundation. Growth Hormone Factsheet. Available
online at:
https://www.pituitary.org.uk/media/624527/GHfact-sheet-2018_EMAIL.pdf
(last accessed May 2022)2 Ghryvelin™ Summary of Product
Characteristics. Available online at:
https://www.ema.europa.eu/en/medicines/human/EPAR/ghryvelin-previously-macimorelin-aeterna-zentaris
(last accessed May 2022)3 Garcia JM et al. Macimorelin as a
Diagnostic Test for Adult GH Deficiency. J Clin Endocrinol Metab,
2018, 103(8): 3083-3093
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