Cubist Pharmaceuticals, Inc. announced that Cubicin (daptomycin for injection) is now approved for marketing in Canada. The approval was granted on last Monday by Health Canada.
Oryx Pharmaceuticals, Inc. (Oryx) has licensed Cubicin for the Canadian market from Cubist. The approved label includes both complicated skin and skin structure infections caused by certain Gram positive infections, at an approved dose of 4 mg/kg, and bloodstream infections, including right-sided infective endocarditis, caused by Staphylococcus aureus, at an approved dose of 6 mg/kg.
Cubicin is currently the only once-daily bactericidal antibiotic approved in the US for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).
Cubicin is also approved in the US as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus.
Cubicin is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anaemia, constipation, diarrhoea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cubicin, Cubicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to Cubicin.
Oryx President Doug Reynolds said, "There is a great need in Canada for new approved therapies to treat serious, sometimes life-threatening infections, particularly those caused by methicillin-resistant Staphylococcus aureus. We look forward to our commercial launch of the drug, and expect that Cubicin will quickly become an essential part of the infectious disease armamentarium in Canada." Cubist President and CEO Michael Bonney said, "We congratulate the entire Oryx organization on this very important accomplishment, and wish them well with the upcoming launch."
Oryx expects to formally launch Cubicin in Canada by late November. While undergoing the regulatory review process, CUBICIN has been available to Canadian healthcare institutions, when requested, through Health Canada's Special Access Programme (SAP) which provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP will remain active until Canadian inventory is in stock in the Oryx distribution system.
Cubicin, originally introduced in the US in 2003 and approved for an expanded US label in 2006, already has been used to treat more than an estimated 370,000 patients in the US. Other international markets where Cubicin has received regulatory approval for multiple indications include the EU, Switzerland, Taiwan, South Korea, and Israel. Cubist markets Cubicin in the US through its own commercial organization and has licensed the drug for marketing in all other parts of the world.
Oryx is a Canadian specialty pharmaceutical company that commercializes prescription pharmaceutical products in the antiinfective, cardiovascular, CNS, and urology areas.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.