Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
that, through a wholly-owned subsdiary, it has entered into an
amendment (the “Amendment”) of its existing License Agreement with
Novo Nordisk Biopharm Limited (“NNBL”) related to the development
and commercialization of macimorelin.
Under the terms of the original License
Agreement, Novo Nordisk was granted the exclusive right to
commercialize macimorelin in the United States (“U.S.”) and Canada.
Novo Nordisk is currently marketing macimorelin in the U.S. under
the tradename Macrilen™ for the diagnosis of adult growth hormone
deficiency (“AGHD”). Aeterna, in collaboration with Novo Nordisk,
is currently developing the expanded use of macimorelin 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 Q1 of 2021.
Under the Amendment, Aeterna continues to retain
all rights to macimorelin outside of the U.S. and Canada but, in
demonstration of Novo Nordisk’s continued commitment to
macimorelin, Novo Nordisk has agreed to make an immediate upfront
payment to Aeterna of €5 million, which accelerates and
replaces the U.S.$5 million later stage regulatory approval
milestone that Novo Nordisk would have been required to pay only
upon successful achievement of regulatory approval of macimorelin
in the U.S. for the diagnosis of CGHD. Under the Amendment, all
other future potential commercialization milestone payments remain
unchanged. In addition, under the Amendment, Novo Nordisk and
Aeterna have agreed that solely Aeterna will conduct the pivotal
Study P02 in partnership with a contract research organization.
Given the full transfer of development activities to Aeterna, Novo
Nordisk is then adjusting the percentage of Study P02 clinical
trial costs that Novo Nordisk is required to reimburse to Aeterna
from 70% to 100% of costs up to €9 million, and includes
reimbursement of Aeterna’s budgeted internal labor costs. Any
additional external jointly approved Study P02 trial costs incurred
over €9 million will be shared equally between Novo Nordisk and
Aeterna. To reflect Novo Nordisk’s additional and earlier
investment in macimorelin, the royalty payment Aeterna receives on
sales in the U.S. and Canada will be reduced from 15% to 8.5% for
annual net sales up to U.S.$40 million and returns to 15% or more
for annual net sales of macimorelin over U.S.$40 million.
Under the Amendment, both companies will
continue to closely coordinate the activities related to the
development and commercialization of macimorelin in the U.S. and
Canada through a joint steering committee, with each party having
decision rights in certain areas. Novo Nordisk will also receive
co-ownership of the U.S. and Canadian patents and trademarks owned
by Aeterna on macimorelin but will be required to transfer
co-ownership in those patents back to Aeterna on the occurrence of
certain termination events.
In addition, upon regulatory approval of
macimorelin in the U.S. for the diagnosis of CGHD, if Novo Nordisk
determines not to commercialize macimorelin in Canada, then Aeterna
has the option to exclusively license rights to macimorelin in
Canada (but not in U.S.) to a third party. The Amendment also
confirms that Aeterna has the right to use the results from Study
P02, if successful, to support Aeterna seeking regulatory approval
and ongoing efforts to seek partnering opportunities for
macimorelin in Europe and other regions outside of the two
countries licensed to Novo Nordisk, the U.S. and Canada.
“We are pleased with our continued partnership
with Novo Nordisk and the work we are doing to advance the expanded
use of macimorelin for the diagnosis of CGHD after successfully
completing the dose range finding Study P01,” commented Dr. Klaus
Paulini, Chief Executive Officer of Aeterna Zentaris. “The
Amendment of the License Agreement with Novo Nordisk puts a
significant emphasis on the importance of our pediatric
co-development of macimorelin and Novo Nordisk’s commitment to the
continued commercialization and expansion of macimorelin. The
Amendment lowers not only our financial obligation for conducting
Study P02, but also provides us with the benefit of an upfront
non-dilutive payment of €5 million.”
The Amendment will be filed on SEDAR at
www.sedar.com. The foregoing description of the terms of the
Amendment does not purport to be complete and is qualified in its
entirety by reference to the Amendment.
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. 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 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 anticipated benefits of the Amendment,
potential payments to the Company under the Amendment, the Company
obtaining approval of macimorelin for CGHD and the resulting
potential to significantly increase the available patient
population for macimorelin, the Company’s ability to secure
marketing partners for macimorelin for GHD in Europe and elsewhere,
the commencement of the CGHD Study P02, the ability of the Company
to identify and develop therapeutic uses for macimorelin in new
indications and the ability of the Company to expand its pipeline
of products, 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, 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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