AVELOX, FAST-ACTING ANTIBIOTIC, APPROVED IN CANADA.

Bayer Inc. has announced Health Canada's approval of Avelox(R) (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 percent of all antibiotic prescriptions - including non-hospitalized pneumonia, bronchitis and sinusitis.

Avelox(R) has been specifically approved for community- acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Avelox(R) 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(R) 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(R) 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(R) works fast to eradicate the most common bacterial pathogens including atypical, gram positive and gram negative pathogens(1). Avelox(R) 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(R) 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)(2). 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(R) has demonstrated outstanding clinical efficacy against Streptoccus pneumoniae, Mycoplasma pneumoniae, Chlamydia peumoniae and Haemophilus influenzae(3).

"Avelox(R) 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(R) for appropriate patients to ensure they get the treatment they need, and get better, faster. Avelox(R) 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(R) is approved in more than 37 countries including the United States. To date, Avelox(R) 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(R) is 400mg once daily to treat all indicated RTIs. Avelox(R) 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(R) 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(R) 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(R) 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(R) to Bayer's family of antibiotics," said Philip Blake, Executive Vice President and General Manager, Healthcare Division, Bayer Inc. "Bayer developed Avelox(R) to be the ideal respiratory antibiotic and with RTI season quickly approaching, Avelox(R) couldn't have been approved at a better time. We are all confident that Avelox(R) will get people better, faster."

Bayer Inc. is a leading and trusted anti-infective company committed to the appropriate use of antibiotics. Bayer Inc. is one of the leading research- based companies in the healthcare market and as such, aims to make a decisive contribution to improving health by concentrating on the research and development of innovative drug products that improve the standard of therapy and offer distinctive patient advantages.

Bayer Inc., the Canadian subsidiary of the international group Bayer AG (Germany), is research-based with major businesses in life sciences, polymers and specialty chemicals. Bayer Inc. is headquartered in Toronto, Ontario, with a major manufacturing site in Sarnia, Ontario, and employs more than 2,200 people.

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