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Canada Approves Marketing Of Zyvoxam (Linezolid) For Gram Positive Infections

VANCOUVER, BC -- May 8, 2001 -- Pharmacia Canada announced that it has received approval from Health Canada to market its new antibiotic Zyvoxam™ (linezolid), which has been proven to kill gram-positive bacteria that are highly resistant to currently used antibiotics.

Zyvoxam has been developed by Pharmacia for the treatment of community- and hospital-acquired infections caused by gram-positive bacteria, including methicillin-resistant Staphylococci, vancomycin-resistant enterococci and S. pneumoniae. Zyvoxam has been used successfully in Canadian clinical trials to treat patients with severe bacterial infections that resisted multiple antibiotic treatments including vancomycin, until now the drug of last resort for physicians and hospitals fighting the spread of drug-resistant bacteria.

"Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant enterococci (VRE), and multiply-resistant pneumococci are a significant problem throughout Canada, and we are seeing an increased number of these cases in British Columbia," said Dr. Elizabeth Bryce, Director, Infection Control Services, Vancouver General Hospital. "This is an urgent issue. We continue to focus on infection control efforts in hospitals, and to communicate with physicians to ensure the appropriate use of antibiotics."

"Zyvoxam is a useful and effective alternative to the treatments currently available," said Dr. Grant Stiver, Assistant Head, Division of Infectious Diseases, Vancouver General Hospital, and Professor of Medicine, Departments of Medicine and Microbiology, University of British Columbia. "As well, recent studies have also shown that continuation therapy moving patients from hospital-based IV to oral treatment with Zyvoxam can substantially reduce length of hospital stay and costs for certain types of infections."(1)

Zyvoxam comes from the oxazolidinone class of compounds. It is the first new class of antibiotics to be introduced into Canada in more than 30 years, and has a unique mechanism of action that affects bacteria before the initiation of the bacterial growth cycle, attacking bacteria in a way that is different from any other antibiotic currently available.

"Pharmacia recognized the need for new antibiotics with effective coverage and convenient formulations more than 10 years ago," said Michael Cloutier, President, Pharmacia Canada. "We are proud to announce the availability of our new antibiotic Zyvoxam, demonstrating Pharmacia's commitment to research and market innovative pharmaceutical products that meet the urgent needs of Canada's healthcare system."

Dr. David Cook, Vice President, Medical and Regulatory Affairs, Pharmacia, added "Zyvoxam holds great promise for the treatment of serious gram-positive infections. This is a significant medical advance that provides a welcome treatment option for hospitals and physicians confronted with drug- resistant bacterial infections."

Methicillin-resistant Staphylococcus aureus (MRSA), which became commonplace in the United States during the 1980s, has also been increasing in frequency in Canada. In 1995, MRSA rates in Canadian hospitals conducting surveillance averaged only 0.9 percent of all Staphylococcus aureus cases identified and 0.30 cases per 1,000 hospital admissions. By 1999, these rates had risen steeply, to 6.0 percent of all Staphylococcus aureus infections tested, and 4.12 cases per 1,000 hospital admissions. In Ontario alone, the number of new patients with MRSA jumped from 475 in 1993 to 8,016 in 1998.(3)

Infections of vancomycin-resistant enterococci (VRE) have become entrenched in many U.S. hospitals, affecting patients with bone-marrow, liver and heart transplants, acute leukemia and patients receiving post-surgical care. Recently, the occurrence of VRE has become more widespread in Canada as well. Canada's passive reporting network screening for VRE found 263 cases of VRE from 1994-1998, and these cases occurred at over 100 healthcare facilities in all provinces.(2)

Zyvoxam has demonstrated in vitro and in vivo activity against gram- positive bacteria, including those that are resistant to other antibiotics. Zyvoxam is available in IV and tablet dosage forms. The 100 percent bioavailability of the tablets provides an added benefit of rapid IV to oral continuation therapy, or oral therapy alone.

Analyses of the late stage clinical trials show that Zyvoxam is safe and highly effective in treating gram-positive bacterial infections. The clinical trial results also show that Zyvoxam is well-tolerated, with the most common drug-related medical events being headache, nausea and diarrhea that were usually mild to moderate in intensity.

Zyvoxam was approved for use in the United States by government authorities in April 2000. It has also been approved by government regulatory authorities in Mexico, Japan, the United Kingdom, and 15 countries throughout Latin America, Europe and Asia.


REFERENCES:

1. Zhiming, Li et al. Comparison of Length of Hospital Stay for Patients with Known or Suspected Methicillin-Resistant Staphylococcus Species Infections Treated with Linezolid or Vancomycin: A Randomized, Multicenter Trial. Pharmacotherapy 2001; 21 (3): 263-274.

2. Conly, John et al. The emerging epidemiology of vancomycin resistant enterococci in Canada 1993-1998: Results from the Canadian Nosocomial Infection Surveillance Program (CNISP) Passive Reporting Network Presentation to Canadian Journal of Infectious Diseases Conjoint Meeting on Infectious Disease, Edmonton Alberta, October 31 1999.

3. Kim, Tony et al. The Economic Impact of Methicillin-Resistant Staphylococcus aureus in Canadian Hospitals. Infection Control and Hospital Epidemiology February 2001; 22 (2): 99-104.


SOURCE: Pharmacia Canada Inc.

Related Link: Pharmacia Canada Inc..

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