Aeterna Zentaris Announces Continued Expansion of Intellectual Property Portfolio for Macimorelin with Additional Patent Appl...
July 31 2020 - 7:35AM
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
the filing of two patent applications on July 22, 2020 related to
its substance macimorelin, an orally available ghrelin agonist to
be used in the diagnosis of patients with adult growth hormone
deficiency (“AGHD”) and childhood-onset growth hormone deficiency
(“CGHD”).
Based on the positive results from AEZS-130-P01
(“Study P01”) evaluating macimorelin as a growth hormone
stimulation test for the evaluation of CGHD, the Company filed a
U.S. provisional application as well as a patent application under
PCT (Patent Cooperation Treaty). Both patent applications relate to
the invention of macimorelin as a method to diagnose growth hormone
deficiency in pediatric patients.
“We are encouraged with the data macimorelin has
demonstrated to date and believe it holds significant potential to
expand into pediatric use. These patent applications, once granted,
are expected to support Aeterna’s business case for its continued
development and efforts to seek regulatory approval pending the
outcome of our second pediatric study, P02, evaluating macimorelin
acetate in pediatric patients from 2 years of age to 18 years of
age with suspected growth hormone deficiency,” commented Dr. Klaus
Paulini, Chief Executive Officer of Aeterna.
For results of Study P01, please visit EU
Clinical Trials Register and reference EudraCT #2018-001988-23.
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 (AGHD). 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 (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 potential of Macrilen™ (macimorelin)
to expand into pediatric use and the granting of the two patent
applications 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 to obtain approvals for the two patent
applications, our ability 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 Thomas JTC Team T (US): +1 (833) 475-8247 E:
aezs@jtcir.com
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