Aeterna Zentaris Secures New European Patent Related to Use of Macimorelin for the Diagnosis of Growth Hormone Deficiency in Adults
April 19 2022 - 7:05AM
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 European Patent Office
(EPO) has issued a patent providing intellectual property
protection of macimorelin in 27 countries within the European Union
as well as additional European non-EU countries, such as the UK and
Turkey, for macimorelin (Ghryvelin®; Macrilen™) for use to diagnose
growth hormone deficiency (GHD) in adults.
Macimorelin, a ghrelin agonist, is an orally
active small molecule that stimulates the secretion of growth
hormone (GH) from the pituitary gland. Stimulated growth hormone
levels are measured in blood samples after oral administration of
macimorelin for the assessment of GHD. Macimorelin is the only U.S.
Food and Drug Administration and European Commission approved oral
diagnostic for adult growth hormone deficiency.
Dr. Klaus Paulini, Chief Executive Officer of
Aeterna, commented, “Patents are an important tool to protect our
intellectual property and a critical step in bringing any new drug
to market. So we are pleased to have such stronger protection
around our innovative product Ghryvelin™/ Macrilen™ in the EU, and
several non-EU countries. There is also an opportunity to build
greater protection by entering the patent in the national phase in
41 European countries, and we will move ahead with a plan to take
advantage of this. This patent also provides protection for our
licensing partner in Europe and the United Kingdom, Consilient
Health, for the commercialization of macimorelin.”
Patent
Details
The patent was issued pursuant to Article 97 (1)
of the EPC, with the number EP3729100. The new European patent
covers the use of macimorelin to detect GHD in adults, with a base
patent term extending until 2038. The EP3729100 patent claims
exactly the label of the product approved by the European
Commission (EC) in January 2019. The patent provides intellectual
property protection of macimorelin in 27 countries within the
European Union as well as additional European non-EU countries,
such as UK and Turkey.
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™), 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: Aeterna’s expectations with respect to the impact of the new
European patent on the Company’s intellectual property portfolio
and the commercial product Ghryvelin® / Macrilen™, the Company’s
ability to successfully enter the national phase, and the ability
of Consilient Health to use the new European patent to protect its
intellectual property.
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,
our other products under development may not be successful; our
ability to raise capital and obtain financing to continue our
currently planned operations; 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 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); the global instability due to the global pandemic of
COVID-19 and the invasion of the Ukraine, 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 40-F
and annual information form, 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
Aeterna Zentaris (TSX:AEZS)
Historical Stock Chart
From Dec 2024 to Jan 2025
Aeterna Zentaris (TSX:AEZS)
Historical Stock Chart
From Jan 2024 to Jan 2025