The Medicines Company announced the results of a phase III clinical trial of ProFibrix's lead biologic, Fibrocaps, and, based on its review of those results, completed its previously announced purchase of the company.
The Medicines Company entered into an agreement with ProFibrix in June to purchase all of its equity subject to its review of the results of the FINISH-3 trial. It now has purchased all of the outstanding equity of ProFibrix for $90 million at the closing and agreed to pay ProFibrix equity holders up to an additional $140 million upon the achievement of agreed-upon U.S. and European regulatory approvals and sales milestones.
Fibrocaps is a dry powder topical formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery. The phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery.
The Medicines Company expects the results of FINISH-3, which was conducted at 65 sites across the U.S. and Western Europe, to support a biologics license application (BLA) with the FDA, and a marketing authorization application (MAA) with the EMA. ProFibrix has also 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 hemostat delivery systems and their accessories was granted ISO 14385: 2003 certification.
Dr. Kenneth L. Renkens, spine surgeon at the Indiana Spine Group and one of the Principal Investigators of FINISH-3, said, "The combined ease of use and efficacy of Fibrocaps have the potential to constitute an important advance in surgical hemostasis. Furthermore, the spray device could become an important tool to use in surgery and to apply Fibrocaps."
“ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products,” said Clive Meanwell, chairman and chief executive officer of The Medicines Company. “We plan to integrate the ProFibrix team with our existing Recothrom team, expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."
Jan Öhrström, M.D., chief executive officer of ProFibrix and former senior vice president of development and chief medical officer of ZymoGenetics, said, "It is clear to me that the ProFibrix team, Fibrocaps and our recombinant fibrinogen program are a natural fit with The Medicines Company's perioperative and hemostasis programs. With our Leiden site as a center for hemostasis at The Medicines Company, we look forward to the seamless integration of our Seattle and Leiden based teams and to continue the development of innovative hemostasis products."
The Medicines Company anticipates peak Fibrocaps revenues of greater than $300 million if approved in major markets. The company expects one time deal costs and incremental operating expenses, including transaction costs and amortization of intangibles, to be approximately $9 to $12 million in the third quarter 2013.