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 Pharmanovia, a global
lifecycle management healthcare company, has acquired from the
Company’s existing EEA and UK partner, Consilient Health, the
exclusive rights and license to commercialize GHRYVELIN™
(macimorelin) in the territory for the diagnosis of Adult Growth
Hormone Deficiency (AGHD) and, if approved, for Childhood Onset
Growth Hormone Deficiency (CGHD).
Dr. Klaus Paulini, Chief Executive Officer of
Aeterna commented, “Pharmanovia has established global expertise in
marketing diagnostic testing solutions in addition to an
established footprint in endocrinology across Europe. They are
positioned as the natural choice as our commercialization partner
moving forward. We believe that the decision by Pharmanovia to
invest in GHRYVELIN™ demonstrates the future potential of
GHRYVELIN™ and is an endorsement of the efforts made to date by
both Aeterna Zentaris and our former licensee, Consilient Health’s,
to obtain approval for and launch GHRYVELIN™ in Europe. We are
excited to now have Pharmanovia as a partner as we continue our
efforts to benefit patients.”
“Endocrinology is the largest of our four core
therapy areas and the in-licensing of this important novel
medicine, the second in-licensing deal of a novel medicine in
almost as many weeks, speaks to our ability to in-license novel,
complementary products in the therapeutic settings we support,”
commented Pharmanovia CEO, Dr. James Burt. ‘’We are well placed to
use the knowledge and the platform we’ve built through our current
endocrinology work, to ensure that more patients get the diagnosis
they need for this rare and serious condition.”
In 2022, Aeterna Zentaris announced that it will
regain full rights to Macrilen® for the U.S. and Canada from Novo
Nordisk on May 2023 and the Company is actively seeking an
alternate development and commercialization partner for Macrilen®
in the US, Canada and for other territories currently not
partnered.
About
Macimorelin
(Macrilen®;
GHRYVELIN™)
Macimorelin is marketed under the brand name
GHRYVELIN™ (macimorelin) in the UK and European Economic Area and
Macrilen® in the United States for the diagnosis of adult growth
hormone deficiency (AGHD). In addition, Aeterna Zentaris is
currently conducting a pivotal Phase 3 safety and efficacy study
AEZS-130-P02 (also referred to as the DETECT study) evaluating
macimorelin for the diagnosis of childhood-onset growth hormone
deficiency (CGHD).
Macimorelin (Macrilen®; 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 macimorelin for the assessment of AGHD. Approval
of macimorelin was granted by the FDA in 2017 and by the EMEA in
2019, based on Phase III data showing that oral macimorelin
provides accuracy comparable to that of standard insulin tolerance
testing (ITT), but has a more favorable safety profile compared to
ITT. Oral macimorelin also reduces false positive test results,
helping to avoid unnecessary treatment of patients.
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.
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).
For more information, please visit
www.zentaris.com and connect with the Company on Twitter, LinkedIn
and Facebook.
About Pharmanovia
Pharmanovia is a global lifecycle management
healthcare company. Its purpose is to make medicines fit for
tomorrow, to improve the lives of patients globally.
Pharmanovia does this by enhancing established
medicines either by rediscovering, repurposing or re-engineering
iconic brands to improve patient outcomes and experiences both
through in-house development and through strategic
partnerships.
The diverse and growing team operate in over 160
countries across the globe, delivering high-quality solutions,
ethically and sustainably, across four core therapeutic areas –
Endocrinology, Neurology, Cardiovascular and Oncology.
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," "aiming", "anticipates," "believes," "intends,"
"potential," "possible," and similar expressions. Such statements,
based as they are on current expectations of management, inherently
involve numerous risks, uncertainty 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 regarding: its preclinical and clinical studies, its
belief in the potential of Macimorelin (Macrilen®; GHRYVELIN™),
including the ability to complete the DETECT clinical trial
evaluating macimorelin in the diagnosis of GCHD, the ability of the
Company to obtain a development and commercialization partner for
Macrilen® in the U.S., Canada and other territories not partnered
and all future plans for, or the success of, its pre-clinical and
clinical programs and products.
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 reliance on the success of the DETECT clinical trial in the
European Union and U.S. for Macrilen® (macimorelin) in CGHD;
results from our ongoing or planned pre-clinical studies and our
DETECT clinical trial under development may not be successful or
may not support advancing the product further in pre-clinical
studies, to human clinical trials or regulatory approval; 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; the global instability
due to the global pandemic of COVID-19 and the war in the Ukraine,
and their 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 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