AMAG Pharmaceuticals and Norgine B.V. Enter Into Exclusive Licensing Agreement to Commercialize Ciraparantag in Europe, Australia and New Zealand - Seite 2

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.