Raplixa (Fibrin Sealant) Approved by FDA
Vectura Group has confirmed the information released today by The Medicines Company announcing that FDA has approved Raplixa (fibrin sealant) and the RaplixaSpray device to provide adjunctive haemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
The approval triggers a milestone payment to Vectura as part-of the consideration related to the acquisition by The Medicines Company of ProFibrix B.V. in 2013. The final amount of the milestone payment will be determined under the shareholder agreement. In addition, Vectura will potentially receive payments based on certain sales milestones in the US and Europe, plus a single digit royalty on sales of Raplixa.
The patents licensed by Vectura to Profibrix B.V. in relation to Raplixa (previously known as Fibrocaps) were acquired by Vectura as part of its acquisition of Innovata plc.
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