PARSIPPANY, NJ--(Marketwired - Apr 3, 2014) - The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015.
In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) vascular surgery.
"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom® Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.
"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 3, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.