Biotech

Amag merges with Perosphere, adding NOAC antidote

Amag Pharma has struck a merger deal with Perosphere, adding an anticoagulant reversal agent in midstage trials to its rising hematology enterprise.

The phrases of the deal see Amag making an upfront cost of $50 million for privately-held Perosphere, assuming $18.5 million of its debt and different liabilities, and committing to pay as much as $365 million in regulatory and industrial milestones.

Reversal agent ciraparantag is being developed as an antidote to direct Factor Xa inhibitor-targeted novel oral anticoagulants (NOACs)—particularly Bayer/Johnson & Johnson’s Xarelto, Pfizer/Bristol-Myers Squibb’s Eliquis and Daiichi Sankyo’s Savaysa—in addition to low molecular weight heparin (LMWH) enoxaparin.

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Collectively, these medication make billions of {dollars} in gross sales worldwide and are used to deal with round 6 million individuals within the U.S. and 9 million elsewhere for illness like atrial fibrillation, deep vein thrombosis and pulmonary embolism.

While these medication have all proven their value in treating thrombosis-related ailments, there’s all the time a threat that their use can result in uncontrolled bleeding, and in these instances reversal brokers are wanted to change off their exercise. It is estimated that as much as 2% of sufferers handled with NOACs get bleeding issues.

In a part 2b trial, ciraparantag at a dose of 200mg noticed entire blood clotting time (WBCT) returned to regular inside an hour of dosing for all 4 Factor Xa-acting medication.

Perosphere says ciraparantag is totally different to present reversal brokers—which in the mean time include Portola’s AndexXa for Xarelto and Eliquis and Boehringer Ingelheim’s Praxbind for its different NOAC Pradaxa, which works as a thrombin inhibitor.

For a start, it’s a small-molecule drug that may be saved at room temperature and may be delivered in simply 10 minutes. It additionally protects for greater than 24 hours whereas AndexXa’s exercise is for a few hours and works for all Factor Xa inhibitors.

Amag can also be hoping the drug will keep away from a warning of prothrombotic results that seems on AndexXa’s label, and thinks its drug may very well be cheaper to supply.

Perosphere and Amag say they’ve now designed a part 3 program that would start earlier than the tip of subsequent yr, establishing a attainable submitting and approval in 2021 if the mixed firm can win breakthrough drug designation from the FDA. Amag thinks ciraparantag may have peak gross sales potential of $500 million a yr within the U.S. alone.

The merger is all about Perosphere’s lead agent, however Amag will even decide up a few preclinical applications, together with a novel felbamate formulation in growth for epilepsy and traumatic mind damage.

It’s one other step in the direction of diversification for the specialty pharma firm, which is finest identified for its rising vary of girls’s health medicines but additionally sells Feraheme product for iron deficiency anemia.

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