Cubist Pharmaceuticals Inc announced the issuance by the United States Patent and Trademark Office of Patent No. 6,468,967 entitled "Methods for Administration of Antibiotics." This patent would provide U.S. market exclusivity for once-daily administration of Cubist's investigational antibiotic Cidecin (daptomycin for injection), should it receive U.S. regulatory approval, until at least 2019.
This U.S. patent covers methods for administering daptomycin to a human patient in a dose of 3 to 75 mg/kg at dosage intervals from once every 24 hours to once every 48 hours, whether alone or co-administered with an antibiotic other than daptomycin. The patent also covers daptomycin administration via oral, subcutaneous or intravenous administration. In completed and currently enrolling Phase III clinical trials, the daptomycin dosing regimen is 4 or 6 mg/kg delivered intravenously once daily, depending on the clinical protocol.
Scott M. Rocklage, Chairman and CEO of Cubist commented, "The issuance of this patent significantly strengthens what we believe is a solid intellectual property portfolio surrounding our lead compound, daptomycin, in the U.S. We are continuing to pursue similar patent protection in major foreign markets as well."
Cidecin (daptomycin for injection) is the first in a new class of antibiotics that has demonstrated rapid bactericidal activity in vitro against virtually all clinically relevant Gram-positive bacteria, including strains resistant to current therapies. Cidecin is being developed to treat serious and life-threatening infections in hospitalized patients. Cubist is on track to complete a U.S. New Drug Application (NDA) for Cidecin by the end of 2002 and is conducting additional Phase III studies in both infective endocarditis/bacteremia and vancomycin-resistant Enterococcal (VRE) infections.