Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), through its
wholly-owned subsidiary Aeterna Zentaris GmbH, (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
that it has licensed the exclusive worldwide rights to develop,
manufacture and commercialize targeted, highly specific,
autoimmunity modifying proteins (“AIM Biologicals”) for the
potential treatment of neuromyelitis optica spectrum disorder
(“NMOSD”) from the Julius-Maximilians-University Wuerzburg (the
“University”).
“This demonstrates Aeterna’s commitment to
execute on our stated plans of expanding our pipeline to have
multiple assets in research and development. The work that Dr.
Valentin Bruttel and Prof. Joerg Wischhusen have conducted at the
University represents what we believe to be a compelling
opportunity for innovative development in the high-value indication
NMOSD, an orphan indication with significant unmet need,” commented
Dr. Klaus Paulini, Chief Executive Officer of Aeterna.
Prof. Joerg Wischhusen of the University added,
“Based on pre-clinical data obtained by the University to date, the
AIM Biologicals technology has the potential to be a breakthrough
in the treatment of autoimmune-related diseases. It is based on a
mechanism developed by nature to protect the fetus from the
mother’s immune system without compromising immune protection
against foreign antigens. This has the potential to offer a new
treatment for NMOSD patients. We believe that the collaboration
with Aeterna will accelerate the further development towards the
clinic.”
Autoimmunity Modifying (“AIM”)
Biologicals - Targeted Immunosuppressive Therapeutics
During pregnancy, the maternal immune system
tolerates paternal antigens from the embryo but is still effective
to protect mother and embryo from foreign antigens. Parts of the
natural mechanisms responsible for this feto-maternal immune
tolerance form the scientific basis for the concept of AIM
Biologicals.
AIM Biologicals utilize a novel mechanism which
is believed to demonstrate that peptide antigens presented on
immunosuppressive MHC class I molecules can selectively and
efficiently induce antigen-specific tolerance. Based on this
mechanism, the targeted immunosuppressive therapeutics are being
designed as optimized soluble molecules with the goal that they may
be adapted to selectively induce tolerance to various autoantigens.
Pre-clinical studies conducted by the University thus far indicate
that tolerance induction appears to be achieved via selective
elimination of antigen-specific immune effector cells and via
induction of antigen-specific regulatory T cells from naïve T
cells. AIM Biologicals thus have the potential to become highly
specific and effective yet not personalized treatments of
NMOSD.
For the treatment of NMOSD, it is believed that
the AIM Biologicals will present a specific antigen derived from
the water channel protein aquaporin-4 (AQP4) loaded to soluble
immunoregulatory HLA-G protein to selectively induce immunological
tolerance in the central nervous system.
In collaboration with the University and the
University clinic, Aeterna plans to conduct further pre-clinical
research to identify and characterize an AIM Biologicals based
development candidate for the treatment of NMOSD, including meeting
with the regulatory authorities to confirm the further pre-clinical
data required as we work towards advancing such candidate into
human clinical trials.
About Neuromyelitis Optica Spectrum
Disorder (NMOSD)
NMOSD is an antibody mediated inflammatory
central nervous system (“CNS”) disorder that affects about one per
million population per year. NMOSD, also known as Devic disease, is
a chronic disorder of the brain and spinal cord dominated by
inflammation of the optic nerve (optic neuritis) and of the spinal
cord (myelitis). Typical symptoms include visual loss, muscle
spasms, paraparesis, and incontinence. If left untreated, 50% of
individuals with NMOSD will be wheelchair bound and blind, and 30%
will have died within five years after the first attack. The water
channel protein AQP4 is widely expressed in the brain, spinal cord,
and optic nerves. Auto-antibodies directed against the AQP4 channel
play an important role in the pathogenesis of NMOSD.
Currently there are only three approved
medications available for the treatment of NMOSD with very high
annual treatment costs, and the risk of the patient contracting
serious infections. Therefore, there is a strong medical need to
offer new therapeutic options to the patients.
In the U.S. and Europe there are currently
approximately 10,000 to 15,000 patients living with NMOSD. Of these
the AQP4 antibody seropositive patients who represent about 80% of
the NMOSD population are the targeted patients for a potential
therapy based on the AIM Biologicals technology.
Transaction Terms and
Conditions
Under the terms of the exclusive patent license
agreement entered into with the University, Aeterna obtained
worldwide rights to develop, manufacture and commercialize products
for the treatment of NMOSD using the AIM Biologicals technology for
an up-front cash payment of €100,000 and milestone payments to be
paid upon the achievement of certain development and regulatory
milestones as well as royalty payments on net sales. Aeterna will
be responsible for the formal preclinical and clinical development,
regulatory activities, and manufacturing of the licensed products.
Aeterna has also engaged the University and University clinic to
conduct certain pre-development activities with respect to the AIM
Biologicals program to be funded by Aeterna.
The Company intends to continue balancing risks
and secure growth opportunities by re-establishing a diversified,
yet focused, development pipeline to which Aeterna can best
leverage its expertise and experience. Aeterna is focused on
opportunistically utilizing its network with universities in Europe
and the U.S. The license of the AIM Biologicals program for NMOSD
demonstrates Aeterna’s progress towards achieving its goal to
obtain access to innovative development candidates in different
indications, with a focus on rare or orphan indications with
potential significant commercial opportunity.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
macimorelin, is the first and 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
agreement with Novo Nordisk where Aeterna receives royalties on net
sales. According to a commercialization and supply agreement,
MegaPharm Ltd. will seek regulatory approval and then commercialize
macimorelin in Israel and the Palestinian Authority. Additionally,
upon receipt of pricing and reimbursement approvals, Aeterna
expects that macimorelin will be marketed in Europe and the United
Kingdom through a recently established license agreement with
Consilient Health Ltd. and Aeterna will receive royalties on net
sales and other potential payments.
Aeterna is also 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.
Aeterna is actively pursuing business
development opportunities for the commercialization of macimorelin
in Asia and the rest of the world, in addition to other
non-strategic assets to monetize their value. 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 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
include those relating to the potential to obtain the necessary
pre-clinical data and regulatory approvals necessary to advance any
product using the AIM Biologicals technology into human clinical
trials or to develop the AIM Biologicals to treat NMOSD or any
other indication into an approved product, the ability of any
product using the AIM Biologicals technology to compete with
existing approved products (or any other products in development)
for NMOSD, the ability of the Company to obtain approval of
macimorelin for CGHD, the Company’s ability to secure marketing
partners for macimorelin in other key markets, the timing of the
commencement of the CGHD Study P02, and 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", “potential” 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 ability to raise capital
and obtain financing to continue our currently planned operations,
our ability to continue to list our Common Shares on the NASDAQ,
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 with Novo Nordisk, the global instability due to
the global pandemic of COVID-19, and its unknown potential effect
on our planned operations, including studies, our ability to enter
into out-licensing, development, manufacturing, marketing and
distribution agreements with other pharmaceutical companies and
keep such agreements in effect, our reliance on third parties for
the manufacturing and commercialization of Macrilen™ (macimorelin),
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, uncertainties related to the
regulatory process, unforeseen global instability, including the
instability due to the global pandemic of the novel coronavirus,
our ability to efficiently commercialize or out-license Macrilen™
(macimorelin), our reliance on the success of the pediatric
clinical trial in the European Union (“E.U.”) and U.S. for
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 product, our ability to successfully
negotiate pricing and reimbursement in key markets in the E.U. for
Macrilen™ (macimorelin), the outcome of our pre-clinical and
clinical development efforts of in-licensed products (including the
AIM Biologicals), any evaluation of potential strategic
alternatives to maximize potential future growth and shareholder
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, and 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.
Investor Contact:
Jenene Thomas JTC Team T (US): +1 (833) 475-8247 E:
aezs@jtcir.com
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From May 2024 to Jun 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Jun 2023 to Jun 2024