PARSIPPANY, NJ--(Marketwired - Jan 13, 2014) - The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has designated Carbavance™ as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides Carbavance priority review by the FDA, eligibility for the FDA's "fast track" status, and an additional five years of exclusivity upon approval of the product for intravenous use in six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia.
The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012.
"We believe a priority review and approval will help us bring the novel Carbavance to patients with serious gram negative infections more quickly," said Clive Meanwell, MD, PhD, Chairman and CEO of The Medicines Company. "Advancing Carbavance serves our purpose to save lives, alleviate suffering, and contribute to the economics of healthcare by serving leading hospitals."
Carbavance is an investigational agent that is a combination of a novel beta-lactamase inhibitor (RPX7009) with a carbapenem for intravenous treatment of hospitalized patients with serious infections. RPX7009 is the first of a novel class of beta-lactamase inhibitors designed by Rempex Pharmaceuticals, a wholly owned subsidiary of The Medicines Company, to inhibit the KPC (Klebsiella pneumoniae carbapenemases) enzyme, the primary resistance mechanism to carbapenems. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) globally and are classified by the US Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat. Carbavance has completed Phase 1 dose-escalation studies in normal subjects, and is expected to enter registration studies in 2014.
Michael Dudley, PharmD, Senior Vice President of Research and Development and Chief Scientific Officer of Rempex Pharmaceuticals, Inc., stated, "Carbapenems are among the most potent and safe antibiotics, and are now regarded as one of the last lines of defense following worldwide dissemination of cephalosporin resistance. We anticipate that Carbavance will profile better than any antibiotic on the market or currently in clinical development for multi-drug resistant gram-negative infections."
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 3,000 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 infectious 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," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, 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 the Company will make regulatory submissions for product candidates on a timely basis, 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 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 Quarterly Report on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.