FDA Approves The Medicines Company's ORBACTIV™ (oritavancin) for Use in Acute Bacterial Skin and Skin Structure Infections
First and Only Single Dose Antibiotic for the Treatment of Skin Infections Caused by Susceptible Designated Gram-positive Bacteria
ORBACTIV™U.S. Launch Expected in 2H/2014
ORBACTIV approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter trials that evaluated a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV ORBACTIV dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).
“ORBACTIV given as a single dose treatment is a welcome new development
for the treatment of skin infections,” said
“The growing challenge of antibiotic resistance in the U.S. has had a
significant impact on the clinical management decisions in the emergency
ORBACTIV was designated as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies ORBACTIV for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
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ORBACTIV: Indication and Important Safety Information
ORBACTIV™ (Oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
Important Safety Information
Use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after ORBACTIV administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 48 hours after ORBACTIV administration.
ORBACTIV is contraindicated in patients with known hypersensitivity to ORBACTIV.
Warnings and Precautions
Concomitant warfarin use: Co-administration of ORBACTIV and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.
Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 hours.
Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.
Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops.
Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.
Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
Prescribing ORBACTIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The most common adverse reactions (≥ 3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
About Skin and Skin Structure Infections
An estimated 5.2 million patients in the US and
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
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" 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 the extent of the commercial success of the Company’s products, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, 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 with the SEC on August 4, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Media (for this press release only):
Lee Davies, +1 917-679-6368
Senior Vice President