Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) announced today that
it has, through a wholly-owned subsidiary, entered into a license
and assignment agreement with a wholly-owned subsidiary of
Strongbridge Biopharma plc (NASDAQ:SBBP) to carry out development,
manufacturing, registration and commercialization of Macrilen™
(macimorelin) in the United States and Canada.
“We are very excited to partner with
Strongbridge on the commercialization of Macrilen™ (macimorelin) in
the U.S. and Canada,” said Michael Ward, Chief Executive Officer of
Aeterna Zentaris. “We look forward to exploring the various
alternatives to monetizing our rights to Macimorelin outside the
United States and Canada.”
Aeterna Zentaris will receive an upfront cash
payment of US$24,000,000 from Strongbridge, and, for as long as
Macrilen™ (macimorelin) is patent-protected, Aeterna Zentaris will
be entitled to a 15% royalty on net sales up to US$75,000,000 and
an 18% royalty on net sales above US$75,000,000. Following
the end of patent protection in United States or Canada for
Macrilen™ (macimorelin), Aeterna Zentaris will be entitled to a 5%
royalty on net sales in that country. In addition, Aeterna Zentaris
will also receive one-time payments from Strongbridge following the
first achievement of the following commercial milestone events:
- US$4,000,000 on achieving US$25,000,000 annual net sales,
- US$10,000,000 on achieving US$50,000,000 annual net sales,
- US$20,000,000 on achieving US$100,000,000 annual net
sales,
- US$40,000,000 on achieving US$200,000,000 annual net sales,
and
- US$100,000,000 on achieving US$500,000,000 annual net
sales.
Upon approval by the U.S. Food and Drug
Administration (“FDA”) of a
pediatric indication for Macrilen™ (macimorelin), Aeterna Zentaris
will receive a one-time milestone payment of US$5,000,000 from
Strongbridge.
Strongbridge will fund 70% of the costs of a
worldwide pediatric development program to be run by Aeterna
Zentaris with customary oversight from a joint steering committee.
The joint steering committee will be comprised of four persons, two
of whom will be appointed by each of Strongbridge and Aeterna
Zentaris.
The decision to license Macrilen™ (macimorelin)
in the U.S. and Canada was made following a detailed review process
undertaken by a committee of independent directors of Aeterna
Zentaris. The committee of independent directors of Aeterna
Zentaris was advised by Stifel, Nicolaus & Company,
Incorporated. Aeterna Zentaris is continuing to explore various
alternatives to monetizing its rights to Macimorelin in other
countries around the globe, including whether to find other license
partners in these jurisdictions or to use its internal resources to
commercialize Macimorelin in one or more of these countries.
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.
Macrilen™ (macimorelin) is an orally-active
ghrelin agonist that stimulates the secretion of growth hormone.
Macrilen™ (macimorelin) has been granted orphan drug designation by
the FDA for the evaluation of growth hormone deficiency. On
December 20, 2017, the FDA granted Aeterna Zentaris marketing
approval for Macrilen™ (macimorelin) to be used in the diagnosis of
patients with adult growth hormone deficiency
(“AGHD”).
AGHD reportedly affects approximately 60,000
adults across the U.S. and Canada. Growth hormone not only plays an
important role in growth from childhood to adulthood, but also
helps promote a hormonally-balanced health status. AGHD mostly
results from damage to the pituitary gland. It is usually
characterized by a reduction in bone mineral density, lean body
mass, exercise capacity, and overall quality of life as well as an
increase of cardiovascular risks.
About Aeterna Zentaris
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company focused on developing and
commercializing, principally through out-licensing arrangements,
Macrilen™ (macimorelin), an orally available ghrelin agonist, to be
used in the diagnosis of patients with AGHD. On December 20, 2017
Aeterna Zentaris announced that the FDA granted marketing approval
for Macrilen™ (macimorelin). On November 27, 2017, Aeterna Zentaris
announced that the Marketing Authorization Application for the use
of Macimorelin for the evaluation of AGHD was accepted by the
European Medicines Agency (“EMA”)
for regulatory review. For more information about Aeterna Zentaris
and Macrilen™ (macimorelin), visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking
statements made pursuant to the safe-harbor provisions of the U.S.
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws, which reflect our current expectations regarding
future events. Forward-looking statements 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 risks and uncertainties, many of which are discussed
under the caption “Key Information - Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission
(“SEC”) and under the caption
“Risk Factors and Uncertainties” in our management’s discussion and
analysis for the third quarter of 2017. Such statements include,
but are not limited to, statements that relate to the terms of the
Agreement with Strongbridge and Strongbridge’s performance of those
terms, anticipated benefits of the Agreement, potential payments to
Aeterna Zentaris under the Agreement, the ability of Aeterna
Zentaris to achieve regulatory and commercial milestones
contemplated by the Agreement, and other statements related to
anticipated developments in the business of Aeterna Zentaris
involving known and unknown risks and uncertainties, which could
cause the actual results of Aeterna Zentaris to differ materially
from those in the forward-looking statements. Such risks and
uncertainties include, among others, 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 launch the product, the ability of Aeterna Zentaris
to enter into out-licensing, development, manufacturing and
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect, reliance on third
parties for the manufacturing and commercialization of our product
candidates, 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, and, more
generally, uncertainties related to the regulatory process, the
ability of Aeterna Zentaris to efficiently commercialize or
out-license 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 products, the
impact of securities class action litigation, the litigation
involving two former officers of Aeterna Zentaris, or other
litigation, on our cash flow, results of operations and financial
position; any evaluation of potential strategic alternatives to
maximize potential future growth and stakeholder 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, the potential of
liability arising from shareholder lawsuits and general changes in
economic conditions. Investors should consult the quarterly and
annual filings of Aeterna Zentaris with the applicable Canadian
securities regulators and the SEC 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.
For more information, please contact:Aeterna Zentaris
Inc.Michael V. WardChief Executive Officer,
843.900.3201IR@AEZSinc.com
Reilly ConnectSusan J. ReillyPresident,
312.600.6780susan.reilly@reillyconnect.com
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Sep 2023 to Sep 2024