Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ( the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
that it has entered into an exclusive distribution and related
quality agreement (the “Agreement”) with Megapharm Ltd.
(“Megapharm”), a leading Israel-based biopharmaceutical company,
for the commercialization in Israel and the Palestinian Authority
of macimorelin, Aeterna Zentaris’ orally available ghrelin agonist
to be used in the diagnosis of patients with adult growth hormone
deficiency (“AGHD”) and child-onset growth hormone deficiency
(“CGHD”).
Under the terms of the agreement, Megapharm will
be responsible for obtaining registration to market macimorelin in
Israel and the Palestinian Authority, while Aeterna Zentaris will
be responsible for manufacturing, product supply, quality assurance
and control, regulatory support, and maintenance of IP. The
regulatory process for macimorelin in Israel is expected to be
completed in the second half of 2021.
Dr. Klaus Paulini, Chief Executive Officer of
Aeterna commented, “This represents a significant milestone in our
ongoing business development strategy to expand our international
distribution network for macimorelin. We are pleased to add such a
well-respected company as Megapharm to our marketing partners for
macimorelin for the diagnosis of AGHD and CGHD and look forward to
working with them.”
Miron Drucker, CEO of Megapharm, said,
“Macimorelin has demonstrated potential in assessing growth hormone
deficiencies in both adults and children. We are proud to establish
this agreement with Aeterna Zentaris to bring macimorelin to Israel
and the Palestinian Authority.”
About Macimorelin
Macimorelin, 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 GHD.
In December 2017, the United States Food and
Drug Administration (“FDA”) granted Aeterna Zentaris marketing
approval for macimorelin to be used in the diagnosis of patients
with adult growth hormone deficiency. Macrilen™ has been granted
Orphan Drug designation by the FDA for diagnosis of AGHD. In
January 2019, the European Commission granted marketing
authorization for macimorelin to Aeterna Zentaris for diagnosis of
growth hormone deficiency in adults. In March 2017, the Pediatric
Committee of the EMA agreed to the Company’s PIP for macimorelin, a
prerequisite for filing a marketing authorization application for
any new medicinal product in Europe.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
Macrilen™ (macimorelin), is the first and only U.S. FDA and
European Commission approved oral test indicated for the diagnosis
of adult growth hormone deficiency. Macrilen™ is currently marketed
in the United States through a license agreement with Novo Nordisk
and Aeterna Zentaris receives double-digit royalties on sales.
Aeterna Zentaris owns all rights to macimorelin outside of the U.S.
and Canada.
Aeterna Zentaris is also leveraging the clinical
success and compelling safety profile of macimorelin to develop it
for the diagnosis of child-onset growth hormone deficiency, an area
of significant unmet need.
The Company is actively pursuing business
development opportunities for the commercialization of macimorelin
in Europe 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 Megapharm Ltd.
Megapharm Ltd. is a leading Israeli private
pharma marketing company, founded in 1989, exclusively representing
a number of major American, European and Japanese pharmaceutical
companies. Megapharm provides its partners with a full set of
commercial capabilities, including registration, market access and
sales and marketing. Megapharm has demonstrated dynamic sales
growth by developing a strong company presence and expertise in
selected therapeutic areas (i.e. Oncology, Hematology, CNS, Orphan
and metabolic drugs) and a proven track record for obtaining
national reimbursement and inclusion of its products in Health
Funds in Israel. Additional information can be found
at: www.megapharm.co.il.
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 intended use of proceeds 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," 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 ability to continue as a going concern is
dependent, in part, on our ability to transfer cash from Aeterna
Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and
secure additional financing, 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, 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), 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 ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
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