The Medicines Company Announces FDA Approval of RAPLIXA™ (Fibrin Sealant), the First and Only Powdered Fibrin Sealant Ready-to-Use for Mild to Moderate Surgical Bleeding
The Medicines Company (NASDAQ:MDCO) announced today the U.S. Food and Drug Administration (FDA) has approved RAPLIXA™ (fibrin sealant) and the RaplixaSpray™ device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
According to IMS data, it is estimated that every year, approximately 2.6 – 3 million surgical procedures require the use of a topical hemostat product in the U.S.
RAPLIXA requires no thawing, reconstitution, or mixing and can be applied either directly from the vial or with the RaplixaSpray™ device. The device is a low-pressure spray applicator designed to deliver RAPLIXA to larger bleeding surfaces in difficult to reach areas.
“Controlling mild to moderate bleeding during surgery requires a hemostatic agent that is easy-to-use and works well across a range of bleeding settings,” said Grant V. Bochicchio, MD, MPH, FACS, Washington University School of Medicine, St Louis, MO. “RAPLIXA and the RaplixaSpray device provides surgeons with a potential off-the-shelf solution ready to address the challenging bleeding situations we encounter every day.”
“The addition of RAPLIXA to our hemostasis portfolio demonstrates our commitment to surgery and perioperative care by helping improve the pathways of care for surgical patients,” said Clive Meanwell, MD, PhD, Chairman and CEO, The Medicines Company. “We believe surgeons will find RAPLIXA to be a meaningful addition to their surgical practice.”
The approval of RAPLIXA was based on one large Phase 3, multicenter clinical trial involving 721 patients in four countries. This trial demonstrated that RAPLIXA used in conjunction with an absorbable gelatin sponge was superior in achieving hemostasis as compared to treatment with sponge alone when used as an adjunct to hemostasis in patients undergoing vascular, hepatic, spinal, and soft tissue surgery. Adverse events were generally similar between treatment groups and consistent with those observed in patients undergoing surgery.
The Company will discuss this approval in its quarterly earnings call on May 5th at 8:30 am. The conference call will be available via phone and webcast. Dial –in information is listed below:
Domestic Dial-in: +1 (877) 359-9508
International Dial-in: +1 (224) 357-2393
Passcode for both dial-in numbers: 22764656
Replay is available from 11:30 am Eastern time following the conference call through May 12, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 22764656.
This call is being webcast and can be accessed via The Medicines Company website at www.themedicinescompany.com.
About RAPLIXA™ (fibrin sealant)
RAPLIXA is a fibrin sealant comprised of human-plasma derived fibrinogen and thrombin that is indicated to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
Important Safety Information
Do not use RAPLIXA intravascularly. Do not use RAPLIXA for the treatment of severe or brisk arterial bleeding. Do not use RAPLIXA in patients known to have anaphylactic or severe systemic reactions to human blood products.
The intravascular application of RAPLIXA may result in thromboembolic events. Air or gas embolism can occur using air- or gas-pressurized sprayers to administer fibrin sealants. The RaplixaSpray device must be operated according to the manufacturer’s instructions. RAPLIXA may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. The use of RAPLIXA may result in allergic type hypersensitivity reactions. If allergic type hypersensitivity symptoms occur, discontinue administration of RAPLIXA immediately.
The most commonly reported adverse reactions (>5%) in patients treated with RAPLIXA were procedural pain, nausea, constipation, pyrexia, and hypotension.
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: serious infectious disease care, acute cardiovascular care and surgery and perioperative 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," "expects," “hopes” and “potential” 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 physicians, patients and other key decision makers will accept clinical trial results, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, whether third parties on whom the Company relies to manufacture and support the development and commercialization of Raplixa are able to fulfill their obligations or the Company is able to establish or maintain such arrangements; and such other 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 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning