Press
Our goal is to identify areas of need, and fill those needs with unique and innovative products.
Our goal is to identify areas of need, and fill those needs with unique and innovative products.
Mississauga, Ontario September 25, 2007 - Oryx Pharmaceuticals, Inc. (Oryx) announced today that the IV antibiotic CUBICIN® (daptomycin for injection) is now approved for marketing in Canada. The approval was granted on Monday by Health Canada. Oryx has licensed CUBICIN for the Canadian market from Cubist Pharmaceuticals, Inc. (NASDAQ: CBST). 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.
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. Canadian hospitals can obtain information on the SAP at the following website http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index_e.html or by calling (613) 941-2108.
About CUBICIN
CUBICIN is currently the only once-daily bactericidal antibiotic approved in Canada 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, and S. agalactiae. CUBICIN is also approved in Canada 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 anemia, constipation, diarrhea, 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. For the full Canadian Product Monograph, visit www.oryxpharma.com.
About Cubist
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. Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
About Oryx:Oryx (www.oryxpharma.com) is a Canadian specialty pharmaceutical company that commercializes prescription pharmaceutical products in the antiinfective, cardiovascular, CNS, and urology areas.
Oryx is a registered trademark of Oryx Pharmaceuticals, Inc.
Doug Reynolds
President
Oryx Pharmaceuticals Inc.
Tel. (866) 260-6291 (toll free) Ext. 6773
dougr@oryxpharma.ca