AMAG Pharmaceuticals Completes Acquisition of Perosphere Pharmaceuticals
January 17 2019 - 8:00AM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it
has completed the previously announced acquisition of Perosphere
Pharmaceuticals Inc., a private biopharmaceutical company. Through
this acquisition, AMAG adds ciraparantag to its development
portfolio. Ciraparantag is in development as a single dose,
ready-to-use solution for use in patients treated with novel oral
anticoagulants (NOACs) or 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. It is believed that ciraparantag
exerts its effects by binding to and blocking the effects
of NOACs 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 has been granted Fast Track
review designation by the U.S. Food and Drug Administration (FDA)
and has composition of matter patent protection until 2034.
“This acquisition represents a great strategic fit and a unique
opportunity to add an innovative, durable and differentiated
clinical asset to our portfolio,” said William Heiden, AMAG’s
president and chief executive officer. “NOAC therapy represents the
fastest-growing segment of the anticoagulant market in the U.S.,
and there are approximately 15 million people worldwide on NOAC or
LMWH therapy. Unfortunately, patients taking anticoagulants are at
an increased risk for serious bleeding complications. In Phase 2
clinical trials, ciraparantag has been shown to rapidly reverse the
anticoagulant effects of three widely prescribed NOACs and a LMWH,
and the effect was sustained for up to 24 hours.”
AMAG plans to hold an end of Phase 2 meeting with the FDA
later this year to confirm the design of the Phase 3 program, which
is expected to include Phase 3a trials in healthy volunteers
followed by a Phase 3b/4 trial in patients. The company intends to
initiate the Phase 3a trials in the second half of 2019.
Ciraparantag has been well tolerated in clinical trials. To
date, the most common adverse events related
to ciraparantag have been mild sensations of coolness,
warmth or tingling, skin flushing, and alterations in taste.
Provided certain clinical milestones are met, the Phase 3
program will be partially funded by an existing agreement with a
global pharmaceutical company, which does not currently have
commercialization rights to ciraparantag. In addition, as part of
the Phase 3 program, AMAG plans to utilize an automated
coagulometer, currently being developed by an independent company,
Perosphere Technologies Inc.
At closing, AMAG paid the Perosphere equityholders
$40 million in cash consideration (subject to customary
purchase price adjustments) net of approximately $10 million
due to AMAG under a convertible note that Perosphere issued to AMAG
in October 2018. AMAG also repaid $12 million of Perosphere’s
term loan indebtedness and assumed $6.2 million of
Perosphere’s other liabilities.
Perosphere equityholders will be eligible to receive regulatory
milestones of up to $140 million, inclusive of a $40 million
milestone payment upon approval by the European Medicines Agency,
if the final U.S. label has no boxed warning. Perosphere
equityholders are also eligible to receive commercial sales
milestone payments of up to an aggregate of $225 million. The first
sales milestone payment of $20 million would be payable upon
achieving annual net sales of $100 million. On January 7, 2019,
AMAG provided 2019 financial guidance for revenue, operating loss
and adjusted EBITDA, which remains unchanged.
About AMAGAMAG is a
pharmaceutical 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, including women’s health. For additional company
information, please visit www.amagpharma.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, AMAG’s belief that the acquisition
represents a great strategic fit and a unique opportunity to add an
innovative, durable and differentiated Phase 2 clinical asset to
its portfolio; statements regarding ciraparantag, including its
mechanism of action, its potential to rapidly normalize whole blood
clotting time and sustain that effect for up to 24 hours, the
safety data to date and its’ expected benefit to patients;
expectations regarding the market size; AMAG’s expected plans and
timing related to the regulatory and development activity of
ciraparantag, including an end of Phase 2 meeting with the FDA, the
planned Phase 3a and Phase 3b/4 trials and the use of a
coagulometer in the Phase 3 trials; and AMAG’s expectations
regarding the impact of the transaction on the previously announced
guidance for 2019 revenue, operating loss and adjusted EBITDA 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, the risk that ciraparantag
will not be approved on the expected timeline or at all, including
as a result of the clinical trial design and enrollment, or as a
result of any safety issues that may arise as part of such trial;
the risk that, even if approved, the market for ciraparantag may be
smaller than expected or AMAG may not be successful in accessing
such market or otherwise realize the expected benefits of the
acquisition; and those 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, 2017, its
Quarterly Reports on Form 10-Q for the quarters ending June 30,
2018 and September 30, 2018 and subsequent filings with the SEC.
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® is a registered
trademark of AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. Contacts: Investors:
Linda Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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