Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), through its
wholly-owned subsidiary, (“Aeterna” or the “Company”), a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests, today announced that it has
entered into an exclusive licensing agreement (the “Agreement”)
with Consilient Health, Ltd. (“CH” or “Consilient Health”), a
privately owned pharmaceutical company focused on commercializing
medicines in Europe and Middle East, for the commercialization in
Europe and the United Kingdom of macimorelin, Aeterna’s orally
available ghrelin agonist, in any diagnostic application, including
the diagnosis of patients with adult growth hormone deficiency
(“AGHD”) and, subject to receipt of regulatory approval,
childhood-onset growth hormone deficiency (“CGHD”).
Under the terms of the Agreement, CH will be
responsible for obtaining pricing and reimbursement approval in the
European economic area and the United Kingdom, as well as bearing
the regulatory cost for the label extension for pediatric use
pending successful outcome of the upcoming safety and efficacy
study, AEZS-130-P02 (“Study P02”), evaluating macimorelin for the
diagnosis of CGHD. This pivotal Phase 3 Study P02 is expected to be
initiated in Q1 of 2021. Aeterna and Consilient Health have also
entered into a separate commercial supply agreement under which
Consilient Health will purchase macimorelin from Aeterna and
Aeterna will be responsible for supply and product quality. Aeterna
will continue to maintain control of its patents covering
macimorelin in Europe and the United Kingdom.
As agreed, Consilient Health will make an
up-front payment to Aeterna of Euro 1 million and will pay to
Aeterna royalties on net sales of macimorelin ranging from 10% to
20% depending on the level of net sales achieved by Consilient
Health in the particular year. Aeterna will also be eligible to
receive milestone payments associated with the achievement of
pricing and reimbursement approvals in certain countries in Europe
and in the United Kingdom, upon approval of macimorelin in CGHD,
and on the attainment by Consilient Health of other sales based
events.
“This license agreement represents another
significant milestone for the Company as we continue to secure and
bolster our portfolio of marketing partners for macimorelin in key
markets. As a synergistic partner of choice with insight and
commercialization capabilities, we believe that Consilient Health
brings noteworthy expertise that is the right fit for Aeterna. We
are grateful for their partnership and look forward to leveraging
their experience in driving innovative marketing to our
international distribution network for macimorelin,” commented Dr.
Klaus Paulini, Chief Executive Officer of Aeterna Zentaris.
Commenting on the agreement, Ahmed Al-Derzi,
Consilient Health’s CEO stated, “We are delighted to build this
partnership with Aeterna Zentaris for macimorelin. Not only does
the brand further strengthen our growing offering to endocrinology
specialists and their patients but it also strengthens CH’s
position across Europe. Macimorelin is an exciting innovation
in the field of growth hormone deficiency.”
In addition to advancing its pediatric program,
Aeterna is actively pursuing its business development activities
with the goal of securing marketing partners for macimorelin for
the diagnosis of growth hormone deficiency in additional markets
where the Company does not already have partnership agreements.
The Agreement will be filed on SEDAR at
www.sedar.com. The foregoing description of the terms of the
Agreement does not purport to be complete and is qualified in its
entirety by reference to the Agreement.
About Consilient Health
Consilient Health is a pharmaceutical company
with a rich heritage of commercializing products in areas such as
women’s health, urology and endocrinology.
In all of Consilient Health’s planning, the
patient is very much at the center. Considering the needs of both
the healthcare professional and the payer, as well as those of the
patient is key to its commercial success.
Established in 2005, Consilient Health’s success
has been built on cultivating strong partnerships with pharma
companies and on ensuring access and then marketing prescription
healthcare products across Europe and the Middle East.
About MacimorelinMacimorelin, 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,
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 Zentaris receives
royalties on 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 Zentaris will receive
royalties on sales and other potential payments.
Aeterna Zentaris 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.
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.
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 Company obtaining 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," 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), 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
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