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| |  Avelox (Moxifloxacin) New, Fast-Acting Antibiotic, Now Approved In Canada TORONTO, ON -- October 24, 2000 -- Bayer Inc. announced Health Canada's approval of Avelox® (moxifloxacin hydrochloride), a new antibiotic designed to rapidly treat patients suffering with common respiratory tract infections (RTIs). RTIs - which accounted for 10 million Canadian prescriptions in 1999, or 60 per cent of all antibiotic prescriptions - include non-hospitalized pneumonia, bronchitis and sinusitis. Avelox has been specifically approved for community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Avelox will be available in Canadian pharmacies this week, in time to combat RTI season over the coming winter months. "One of the challenges for physicians treating RTIs is to determine which bacteria is causing the infection," said Dr. Lionel Mandell, Chief of the Division of Infectious Diseases, Professor of Medicine, McMaster University, Hamilton. "Avelox provides excellent coverage of the common respiratory pathogens and demonstrates a low level of antibiotic resistance. This is good news because getting treatment right the first time will allow patients to feel better faster, minimize the number of repeat prescriptions and limit the spread of infections," he added. Avelox is fast-acting and provides patients with significant treatment benefits over currently available antibiotics: It provides a shorter course of therapy taken once daily for common RTIs. Avelox works fast to eradicate the most common bacterial pathogens including atypical, gram positive and gram negative pathogens. Avelox reaches all sites of infection just within three hours and continues to target the site of infection even at 24 hours. In worldwide clinical trials, including more than 100 sites in Canada and extensive post- marketing surveillance, Avelox has demonstrated an excellent safety profile and is well-tolerated by patients, causing few of the side effects common to antibiotics (e.g., stomach upset, diarrhea and dizziness). The drug is contraindicated in patients with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics. RTIs, including mild cases, contribute to a considerable loss in productivity and quality of life. RTIs are also incapacitating - they reduce the affected individual's ability to work and are the underlying cause of millions of lost days of work due to ill health. They also increase healthcare expenditures and result in unnecessary visits to hospital emergency departments, often during the peak of influenza season. Each year more than 6,000 Canadians die from pneumonia, and after lung cancer, it is the second leading cause of death due to lung disease. The most commonly detected bacterial pathogens with community-acquired pneumonia (CAP) are Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae and Haemophilus influenzae. The most deadly of these is S. pneumoniae, accounting for 70 per cent of all CAP deaths. Avelox has demonstrated outstanding clinical efficacy against Streptoccus pneumoniae, Mycoplasma pneumoniae, Chlamydia peumoniae and Haemophilus influenzae. "Avelox is a welcome addition to the treatment options for common RTIs," said Dr. Meyer Balter, Division of Respiratory Medicine, Mount Sinai Hospital, Toronto. "With this antibiotic, physicians will now be able to use Avelox for appropriate patients to ensure they get the treatment they need, and get better, faster. Avelox offers a drug regimen that is easy to follow and this alone will increase the probability that patients will fully complete their course of antibiotics," he added. Avelox is approved in more than 37 countries including the United States. To date, Avelox has safely and successfully treated more than two million patients with RTIs worldwide (equivalent to more than 16 million treatment days). The recommended dose for Avelox is 400mg once daily to treat all indicated RTIs. Avelox is also convenient as it is dosed once daily, can be consumed at any time of the day and does not need to be taken with food. Avelox is approved as a five-day course of therapy for chronic bronchitis, seven to 10 days for acute sinusitis, and 10 days for CAP. Avelox has been involved in several clinical trials prior to its approval in Canada. Announced recently was the initiation of the MAP Trial (Moxifloxacin Ambulatory Pneumonia), the largest Canadian researcher-initiated study to determine if patients taking Avelox feel better faster than Clarithromycin in the treatment of CAP, or non-hospitalized pneumonia. The study is currently taking place in 60 centres across Canada and will involve more than 480 patients. Results of the MAP study are expected to be published in 2001. "We are very delighted to add Avelox to Bayer's family of antibiotics," said Philip Blake, Executive Vice President and General Manager, Healthcare Division, Bayer Inc. "Bayer developed Avelox to be the ideal respiratory antibiotic and with RTI season quickly approaching, Avelox couldn't have been approved at a better time. We are all confident that Avelox will get people better, faster."
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