Oct 14 · Positive data from FINISH-3 presented. In this randomised (2:1), single-blind, controlled PIII pivotal trial, pts with mild-moderate surgical bleeding were treated with Raplixa™ (n=480, sprayed on in 50% of cases) or gelatin sponge (n=239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. Raplixa™ significantly reduced time to haemostasis (TTH) vs. gelatin sponge; hazard ratios: 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint) and significantly reduced median TTH for each indication (p<0.0001). Adverse event incidences were similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2% and 3% of pts on Raplixa™ vs. gelatin sponge-treated patients respectively. 
Aug 13 · The Medicines Company has purchased ProFibrix following the positive results from FINISH-3. The Company believes that Fibrocaps are complementary to Recothrom® ProFibrix also has a proprietary recombinant fibrinogen development program that will potentially allow development of the first recombinant thrombin and recombinant fibrinogen combination products .
Aug 13 · Results of the PIII FINISH-3 study reported. The study met all primary and secondary haemostasis efficacy endpoints in four surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. ProFibrix has developed a complementary dry powder spray delivery device to assist surgeons in the accurate application of Fibrocaps. Recently the ProFibrix quality management system for the design, development and control of manufacture of sterile biological haemostat delivery systems and their accessories was granted ISO 14385: 2003 certification. Applications for a European CE mark and for an FDA 510k review for the device are underway 
Jun 13 · The Medicines Company will purchase ProFibrix. subject to a satisfactory review of the pending PIII FINISH-3 trial results of ProFibrix´s lead biologic, Fibrocaps. FINISH-3, has completed enrollment of 719 surgical patients with mild to moderate surgical bleeding and results are expected 3Q 2013. If favorable, FINISH-3 is expected to be sufficient to support a filing for marketing approval in the EU and US .
Apr 13 · Enrolment completed of PIII FINISH-3 on schedule .
Mar 13 · ProFibrix BV is developing Fibrocaps®, a dry powder formulation of fibrinogen & thrombin derived from human plasma, for treatment of acute and severe bleeding associated with elective surgery or trauma. Thrombin is a highly specific protease that transforms fibrinogen into a fibrin clot. Fibrocaps® is formulated using spray drying, which makes small, hollow microspheres of thrombin and fibrinogen. Trehalose carbohydrate is also added during formulation to ensure that the active proteins remain stable and rapidly dissolve in solution. The powder is stored at room temperature and can be applied to the wound without preparation as soon as bleeding starts .
Feb 12 · NCT01527357 (Finish-3) A PIII, international randomized, single-blind, controlled trial of topical Fibrocaps™ plus gelatin sponge vs gelatin sponge alone, for achieving hemostasis in 500 subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery. The primary outcome is Time to Hemostasis (TTH) within 5 minutes. The study will start May 12 and is due to complete May 13 .13/02/2012 09:14:15