Label includes both Complicated Skin and Skin Structure and S. aureus
MISSISSAUGA, ON, Sept. 25 /CNW/ - Oryx Pharmaceuticals, Inc. (Oryx)
announced today that the IV antibiotic CUBICIN(R) (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
CUBICIN, originally introduced in the U.S. in 2003 and approved for an
expanded U.S. label in 2006, already has been used to treat more than an
estimated 370,000 patients in the U.S. 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
U.S. through its own commercial organization and has licensed the drug for
marketing in all other parts of the world.
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.
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,
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.
For further information:
For further information: Oryx Pharmaceuticals, Inc., Doug Reynolds,
President, Tel. (866) 260-6291 (toll free), Ext.6773, email@example.com