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 CiraparantagCiraparantag 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 NorgineNorgine 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.
AMAG Contacts:Investors: Rushmie
Nofsinger(781) 530-6838
Media: Stacy Nartker(781) 430-9212
Norgine Contacts:Clara Bentham +44
(0)1895 826654 or +44 (0)7734 367883 Eleni Fistikaki +44
(0)1895826227 or +44 (0)7825 389477
contact@norgine.comwww.norgine.comFollow us
@norgine
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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