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 is continuing to expand its development pipeline by
initiating a preclinical development program to develop parathyroid
hormone fusion polypeptides (PTH) with delayed clearance based on
proprietary intellectual property exclusively licensed by Aeterna
from The University of Sheffield, UK (the “University”).
Primary hypoparathyroidism, the first indication
to be pursued, is an orphan indication in the field of
endocrinology. It is an uncommon condition in which the body
produces abnormally low levels of PTH. PTH is a key regulating
hormone essential for calcium homeostasis and renal phosphate
clearance for maintaining a balance of those two minerals in the
body. Untreated, primary hypoparathyroidism will cause, among
others effects, renal dysfunction, muscle cramping, twitching,
seizures, and cardiac arrhythmias. Approximately 23 to 37 in every
100,000 individuals in Europe and the U.S. are estimated to suffer
from hypoparathyroidism.
Aeterna will collaborate with Prof. Dr. Richard
J. Ross and his laboratory at the University to continue to advance
this exciting potential new therapeutic treatment option being
studied for chronic hypoparathyroidism in adults. It uses a
proprietary fusion protein consisting of a modified growth hormone
binding protein (GHBP) linked to PTH1-34 with the goal of providing
PTH1-34 with a delayed clearance of one or two weeks. This new
therapy approach has the potential to be self-administered via a
pharmaceutical pen and help patients maintain normal serum calcium
and phosphate levels during chronic use. Working with the
University, the Company will undertake certain additional
confirmatory research studies prior to initiating formal
pre-clinical toxicology and GMP studies and finalizing plans for
the potential initiation of human clinical trials.
“We are continuing to advance on our stated goal
of expanding our pipeline beyond diagnostics with multiple
development programs in potentially high-value indications. With
our well-established knowledge and expertise in the endocrinology
space, we are executing on our goal of adding synergistic assets to
our pipeline to execute on our pipeline expansion strategy. We look
forward to combining the expertise of the Aeterna scientific team
with The University of Sheffield and Prof. Dr. Ross as we work
towards our common goal of helping patients suffering from
hypoparathyroidism while also potentially unlocking significant
value in this proprietary asset,” commented Dr. Klaus Paulini,
Chief Executive Officer of Aeterna.
Prof. Dr. Richard J. Ross of the University of
Sheffield added, “We are excited about the opportunity to work with
Aeterna Zentaris to further research on this new concept of delayed
clearance PTH molecules and potential therapeutic treatment
options. We look forward working with Aeterna to further the
development of PTH fusion polypeptides which I believe have the
potential to address an existing unmet medical need in the
treatment of hypoparathyroidism and may also have the potential in
certain other conditions such as osteoporosis.”
Aeterna continues to strive to balance risks and
secure growth opportunities by re-establishing a diversified, yet
focused, development pipeline which we believe best leverages the
Company’s expertise and experience. The Company remains focused on
utilizing its network with researchers in Europe and the U.S. to
seek opportunities to access innovative development candidates,
with a focus on rare or orphan indications and potential for
pediatric use.
Transaction Terms and
Conditions
Under the terms of the exclusive patent and
know-how license agreement entered into with the University,
Aeterna obtained worldwide rights to develop, manufacture and
commercialize PTH fusion polypeptides covered by the licensed
patents for all human uses for an up-front cash payment of £100,000
and milestone payments to be paid upon the achievement of certain
development, regulatory and sales milestones, as well as low single
digit royalty payments on net sales of those products and certain
fees payable in connection with sublicensing. Aeterna will be
responsible for the further development, manufacturing, approval
and commercialization of the licensed products. Aeterna has also
engaged the University under a research contract to conduct certain
research activities to be funded by Aeterna, the results of which
will be included within the scope of the license granted to
Aeterna.
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 has entered into the
start-up phase for the clinical safety and efficacy study, Study
P02, evaluating macimorelin for the diagnosis of CGHD, which is
expected to be initiated in Q2 of 2021.
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.
About The University of
Sheffield
With almost 29,000 of the brightest students
from over 140 countries, learning alongside over 1,200 of the best
academics from across the globe, the University of Sheffield is one
of the world’s leading universities. A member of the UK’s
prestigious Russell Group of leading research-led institutions,
Sheffield offers world-class teaching and research excellence
across a wide range of disciplines.
Unified by the power of discovery and
understanding, staff and students at the university are committed
to finding new ways to transform the world we live in. Sheffield is
the only university to feature in The Sunday Times 100 Best
Not-For-Profit Organizations to Work For 2018 and for the last
eight years has been ranked in the top five UK universities for
Student Satisfaction by Times Higher Education.
Sheffield has six Nobel Prize winners among
former staff and students and its alumni go on to hold positions of
great responsibility and influence all over the world, making
significant contributions in their chosen fields. Global research
partners and clients include Boeing, Rolls-Royce, Unilever,
AstraZeneca, Glaxo SmithKline, Siemens and Airbus, as well as many
UK and overseas government agencies and charitable foundations.
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 in
this press release include those relating to the development and
expansion of the Company’s diversified pipeline of development
assets, the initiation of a preclinical program for the development
of a new therapeutic treatment option for primary
hypoparathyroidism or any other conditions based on the
intellectual property licensed from the University and Aeterna’s
expectation that, upon receipt of pricing and reimbursement
approvals, macimorelin will be marketed in Europe and the United
Kingdom and the initiation of Study P02, which is expected to be
initiated in Q2 of 2021. 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, 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