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The Medicines Company
MDCO and ProFibrix B.V. today announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to The Medicines Company's satisfactory review of the pending Phase 3 clinical trial results of ProFibrix's lead biologic, Fibrocaps(TM).Fibrocaps is a dry powder topical formulation of fibrinogen and thrombin being developed to stop bleeding during surgery. The Phase 3 trial, FINISH-3, has completed enrollment of 719 surgical patients with mild to moderate surgical bleeding. Results of FINISH-3 are expected in the third quarter of 2013. If the results are favorable, FINISH-3 is expected to be sufficient to support a BLA filing in the United States and an MAA filing with the European regulatory authorities.Under the terms of the agreement, The Medicines Company will pay ProFibrix a $10 million upfront option payment. If the Medicines Company is satisfied with the trial results of FINISH-3 and determines to proceed, it will purchase all of the outstanding capital stock of ProFibrix at closing. Otherwise, The Medicines Company may terminate the transaction with no further obligation to the ProFibrix shareholders. ProFibrix shareholders
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