PARSIPPANY, NJ -- (Marketwired) -- 11/12/13 --
The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has designated oritavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides oritavancin priority review by the FDA, eligibility for FDA's "fast track" status, and an additional five years of exclusivity upon approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). 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.
The Medicines Company plans to submit a New Drug Application to the FDA in the fourth quarter of 2013 for the use of oritavancin in ABSSSI caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
The Medicines Company completed two Phase 3 clinical trials for oritavancin, SOLO I and SOLO II, in December, 2012 and July, 2013 respectively. These Phase 3 trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA. The combined SOLO studies of 1,959 patients (modified intent-to -treat population, or mITT) represent the largest patient population ever evaluated for an anti-infective for the treatment of ABSSSI in controlled clinical trials. In addition, the combined SOLO trials have assessed one of the largest subsets of patients with documented MRSA infection, with 405 patients out of the 1,959 mITT patients suffering from a documented MRSA infection.
"We believe a priority review and approval will help us bring oritavancin, a single dose treatment, to patients with ABSSSI more quickly," said Matthew Wikler, MD, Vice President Medical Director, Anti-infectives Solutions for The Medicines Company. "With oritavancin eligible for additional exclusivity, The Medicines Company can continue our planned development for oritavancin for the potential treatment of additional serious gram-positive bacterial infections."
Oritavancin is an investigational antibiotic in development for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). In clinical trials, the most frequently reported adverse events associated with oritavancin were nausea, headache, vomiting and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents including oritavancin.
About The GAIN Act
The GAIN Act, Title VIII (Sections 801 through 806) of the FDASIA, provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases caused by drug resistant pathogens. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant resistant gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile. Resistant gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species are also included.
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 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 Registration Statement 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.
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
Senior Director, Investor Relations & Communications
The Medicines Company
+1 (973) 290-6097
Source: The Medicines Company