Wednesday, February 13, 2013

ProFibrix Phase III Trial with FibrocapsTM (FINISH-3) Passes Important Safety Milestone & Almost Completes Enrolment

LEIDEN, The Netherlands & SEATTLE -- 
ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.
To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to complete enrolment have already been recruited into the study. Two of the four surgical indications, spinal and soft tissue surgery, completed enrolling. Full enrolment is expected to be completed in April 2013 and final results from the study are anticipated in June 2013.
Jan Öhrström, Chief Executive Officer of ProFibrix said: “The positive review by the DMC bodes well for our filings with U.S. and EU authorities in the fall of 2013. Furthermore, the strong support of the investigators involved in FINISH-3 has resulted in an amazing speed of enrolment. This strengthens our belief that Fibrocaps has the hallmarks to capture a significant part of the fast growing USD 1 billion topical hemostat market.”
About Fibrocaps
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
About the FINISH-3 trial
FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control for the treatment of mild to moderate bleeding in 672 subjects undergoing spinal, liver, vascular and soft tissue surgery (n=168 in each indication), conducted at 65 sites across Europe and the U.S.

MDCO, Bristol-Myers Squibb begin global alliance for Recothrom

The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective.

The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions.

Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We believe that completing this deal is another step to establish The Medicines Company as a leader in acute and intensive care medicine globally."

Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin) and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as "active" hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats and fibrin sealants. Recothrom was approved in the United States in January 2008 and in Canada in December 2010.

The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide.