Agreement provides AMAG with $30
million upfront payment and eligibility to receive up to
$260 million in development and
commercial milestones in addition to sales royalties
Collaboration further advances the development of
ciraparantag
WALTHAM, Mass. and AMSTERDAM, July 23,
2020 /PRNewswire/ -- AMAG Pharmaceuticals, Inc.
(NASDAQ: AMAG) and Norgine B.V., a leading European specialist
pharmaceutical company, today announced they have entered into
an exclusive licensing agreement to develop and commercialize
ciraparantag in Europe,
Australia and New Zealand. Ciraparantag is in development
for use in patients treated with direct oral anticoagulants (DOACs)
and low molecular weight heparin (LMWH) when reversal of the
anticoagulant effect of these products is needed for emergency
surgery, urgent procedures or due to life-threatening or
uncontrolled bleeding.
Under the terms of the license agreement, AMAG will receive
$30 million of total upfront
consideration and up to $260 million
contingent upon the achievement of certain regulatory and sales
milestones together with escalating double-digit royalties.
Additionally, Norgine has committed to contribute one-third of the
costs of the Phase 3 clinical program, which would be conducted by
AMAG to support regulatory approval of ciraparantag by the U.S.
Food and Drug Administration, the European Medicines Agency, and
the Medicines and Healthcare Products Regulatory Agency. AMAG will
continue to oversee the Phase 3 clinical program, while working
closely with Norgine. Norgine will be responsible for the
regulatory filings and any subsequent clinical trials required for
approval in its territory and will eventually hold all marketing
authorizations in the licensed territories.
"This agreement is a significant milestone on our strategic
evolution. We are looking forward to partnering with Norgine and
working together to unlock the value of ciraparantag, which will
further strengthen our company's ability to continue investing in
innovative therapies that address urgent unmet medical needs," said
Scott Myers, AMAG's Chief Executive
Officer. "Norgine's infrastructure and capabilities to develop and
commercialize products will help us further advance the program
into Phase 3 clinical trials and work towards regulatory approval
in countries where providers and patients may benefit from a
reversal agent."
There are currently approximately six million patients in the
U.S. and nine million patients in certain ex-U.S. countries on DOAC
and LMWH therapy.[1] A recent study found
that approximately 1.5-2% of patients taking certain DOACs can be
at risk for serious bleeding complications each
year.[2]
"We are delighted to enter into this new collaboration with AMAG
to develop and commercialize ciraparantag in Europe, Australia and New
Zealand," said Peter Stein,
Chief Executive Officer of Norgine. "Patients who take
anticoagulants can be at risk of serious and uncontrolled bleeding,
especially in emergency situations, and we are proud to be able to
support the development of a new, potentially life-saving
treatment, subject to successful completion of ciraparantag's
research programme and subsequent regulatory approval."
About Ciraparantag
Ciraparantag is a novel small, water-soluble molecule being
investigated for reversal of anticoagulation induced by direct oral
anticoagulants (DOACs) or low molecular weight heparin (LMWH).
Target patient populations include patients for whom rapid reversal
of anticoagulation is needed because of life-threatening or
uncontrolled bleeding, or for emergency surgery or urgent
procedures. It is believed that ciraparantag exerts its effects by
binding to and blocking the effects of DOACs such as Xarelto®
(rivaroxaban), Eliquis® (apixaban) and Savaysa® (edoxaban), as well
as to the LMWH Lovenox® (enoxaparin sodium injection), which in
turn reestablishes normal clot formation. Ciraparantag is
administered by intravenous infusion; the anticipated clinical
treatment regimen is a single dose administered over approximately
10 minutes. Ciraparantag has been studied across seven completed
trials, with 277 subjects having been dosed with ciraparantag and
has been well tolerated in these studies. To date, the most common
adverse events related to ciraparantag have been mild transient
sensations of warmth or skin flushing, skin tingling, and
alterations in taste. The safety and efficacy of ciraparantag is
under investigation through the ongoing clinical development
program.
ABOUT AMAG
AMAG is a commercial stage biopharmaceutical company focused on
bringing innovative products to patients with unmet medical needs.
The company does this by leveraging its development and commercial
expertise to invest in and grow its pharmaceutical products across
a range of therapeutic areas. For additional company information,
please visit www.amagpharma.com.
About Norgine
Norgine is a leading European specialist
pharmaceutical company that has been bringing transformative
medicines to patients for over a century. Our commitment to
transforming people's lives drives everything we do and our
European experience, fully integrated infrastructure and
exceptional partnership approach enables us to quickly apply
creative solutions to bring life-changing medicines to patients
that they may not otherwise be able to access. Norgine is proud to
have helped 22 million patients around the world in 2019 and
generated €419 million in net product sales, a growth of 6% over
2018.
Norgine has a direct presence in 12 European countries, as well
as Australia and New Zealand. We also have a strong global
network of partnerships in non-Norgine markets. We are a flexible
and fully integrated pharmaceutical business, with manufacturing
(Hengoed, Wales and Dreux,
France), third party supply
networks and significant product development capabilities, in
addition to our sales and marketing infrastructure. This enables us
to acquire, develop and commercialize specialist and innovative
products that make a real difference to the lives of patients
around the world.
In 2012, Norgine established Norgine Ventures, a complementary
business which supports innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more information,
please visit www.norgineventures.com.
Forward Looking Statements
This press release
contains forward-looking information about AMAG Pharmaceuticals,
Inc. within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Any statements
contained herein which do not describe historical facts, including,
among others, expectations about the benefits of the transaction to
AMAG's corporate strategy and strategic evolution, including its
ability to unlock value in ciraparantag and continue investing in
innovative therapies; beliefs about the benefits of the partnership
on the development and regulatory approval of ciraparantag; beliefs
about ciraparantag's potential benefits to patients; AMAG's
expected plans related to the clinical development of ciraparantag
and Phase 3 clinical program to support regulatory approval in the
U.S., Europe, Australia, and New
Zealand; statements regarding Norgine eventually holding all
marketing authorizations in the licensed territories;
statements regarding the potential market size and target patient
population; statements regarding ciraparantag, including its safety
and mechanism of action, are based on management's current
expectations and beliefs and are forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those discussed in such forward-looking
statements.
Such risks and uncertainties include, among others, risks and
uncertainties related to the scale and scope of the COVID-19
pandemic and its impact on AMAG's revenues and , operations, and
clinical development (including, more specifically, the
ciraparantag clinical development program), as well as COVID-19's
impact on AMAG's business partners, healthcare providers, patients,
employees and the health care industry and worldwide economies
generally; uncertainties regarding AMAG's and Norgine's ability to
successfully and timely complete clinical development programs and
obtain regulatory approval for ciraparantag in the U.S.,
Europe, Australia and New
Zealand, including as a result of clinical trial design or
enrollment, or as a result of any safety or efficacy issues that
may arise as part of such trial; the risk that the cost of the
clinical development of ciraparantag will be more than planned or
that the timeline will be significantly delayed; the risk that even
if approved, the market for ciraparantag may be smaller than
expected or AMAG and Norgine may not be successful in
commercializing in such market or otherwise realize the expected
benefits of the transaction; uncertainties regarding the
manufacture of ciraparantag and our ability to supply Norgine; the
risk that AMAG or Norgine will fail to fully perform their
respective obligations under the license agreement; and those other
risks identified in AMAG's filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K
for the year ended December 31, 2019,
its Current Reports on Form 8-K, its Quarterly Reports on Form
10-Q, including for the quarter ended March
31, 2020, and in any subsequent filings with the SEC , which
are available at the SEC's website at www.sec.gov. Any such risks
and uncertainties could materially and adversely affect AMAG's
results of operations, its profitability and its cash flows, which
would, in turn, have a significant and adverse impact on AMAG's
stock price. AMAG cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made.
AMAG disclaims any obligation to publicly update or revise any
such statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals®, the logo and designs, are registered
trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks
referred to in this report are the property of their respective
owners.
[1] Perosphere sponsored commercial assessment report conducted
by a third party in May 2016.
[2] Tepper, Ping G et al. (2018) Real-world comparison of
bleeding risks among non-valvular atrial fibrillation patients
prescribed apixaban, dabigatran, or
rivaroxaban" PLoS ONE 13(11):
e0205989. https://doi.org/10.1371/journal.pone.0205989
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