Tamiflu, Pill For Influenza, Available In Canada
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Tamiflu, Pill For Influenza, Available In Canada

MISSISSAUGA, ON -- January 4, 2000 -- With the flu season in full swing, the first easy-to-use flu treatment pill has been approved. Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved Tamiflu(TM) (oseltamivir), the first pill to treat all common strains of influenza (A and B). The company also announced that Tamiflu is available immediately in Canadian pharmacies.

"Unlike over-the-counter medications that only mask the symptoms of influenza, Tamiflu is a prescription antiviral agent that targets the actual influenza virus and stops it from replicating and spreading from cell to cell," said Dr. Fred Aoki, Professor of Medicine, the University of Manitoba. "Tamiflu has the advantage of being administered orally, which makes it not only easy to take but also easy to use," added Dr. Aoki.

A recent independent study, "Usage and Attitude Study Among Canadians", revealed that 66 per cent of physicians would prefer Tamiflu to Ralenza as their influenza treatment of choice. The study also showed that 85 per cent of patients would prefer a flu pill to an inhaled treatment. Physicians rated Tamiflu to Relenza significantly higher in categories, such as ease of dosing, ease of use, reduction in duration of influenza, compliance and effect on the ability of patients to resume normal activities. Roche Canada commissioned the study.

"Physicians and patients have been anxiously awaiting the approval of Tamiflu, and Roche is pleased that Tamiflu is now available to Canadians," said Lorenzo Biondi, Vice President, Regulatory Affairs, Roche Canada. "Influenza is a serious medical illness that can have a devastating impact on patients. With its accurate and convenient dosing, Tamiflu is set to revolutionize the treatment of influenza in Canada," concluded Mr. Biondi.

"Each flu season, influenza kills thousands of Canadians, especially those in high-risk groups," said Lillian Morgenthau, President, CARP (Canada’s Association for the 50 Plus). "We are encouraged that new drugs, including Tamiflu, are now approved and available in Canada to treat and stop the spread of influenza. People must seek immediate medical attention if they are experiencing flu symptoms, and we urge governments to grant full access and coverage for this potentially life-saving treatment," she added.

Co-developed with Gilead Sciences, Tamiflu is part of a new breakthrough class of drugs called neuraminidase inhibitors, which targets one of the two major surface structures of the influenza virus, the neuraminidase protein. The neuraminidase site is virtually the same in all common strains of influenza. If neuraminidase is inhibited, the virus is not able to effectively replicate and spread to other cells.

Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than two days. The recommended oral dose of Tamiflu is 75 mg twice daily for five days.

"We are continually searching for new treatments to improve patient care. With Tamiflu, we are pleased that Canadian flu sufferers will now have access to an easily-administered oral product that will simplify treatment, ensure better compliance and get patients healthy, quickly," said Mr. Biondi. "The approval of Tamiflu is an exciting and important development for Roche Canada. As a leader in antiviral therapies, the availability of Tamiflu, for the treatment of influenza, further demonstrates our commitment to this area," he added.

Studies conducted throughout Canada, the United States, Europe, South America and Australia have concluded that Tamiflu significantly decreases the duration of illness and alleviates common influenza symptoms (i.e., fever, cough, muscle aches and pains) by up to two days compared to patients receiving placebo. In another important finding, Tamiflu reduced the incidence of secondary flu complications, such as pneumonia, sinusitis and bronchitis in previously healthy adults.

"The one to two day decrease in duration was statistically significant in all pivotal trials as well as clinically significant to patients," said Dr. Anthony D’Urzo, Director, Primary Care and Lung Clinic, Toronto. "When asked, patients strongly agreed that the decrease in the duration of illness was significant. Most importantly, Tamiflu means flu patients will be able to return to their normal activities sooner and feel better faster," he added.

Ongoing studies have shown that Tamiflu is equally well-tolerated and safe for use in both elderly patients (65 years and older) and younger adults. No dose adjustments are required when treating these populations.

The most frequently reported side effects in these studies in patients taking Tamiflu were nausea and vomiting. These events were generally mild to moderate and transient, and were generally limited to the first dose. Less than one per cent of patients discontinued prematurely from clinical trials due to nausea and vomiting.

According to data from Health Canada, each year up to four million Canadians develop influenza, an average of 75,000 Canadians are hospitalized and approximately 6000 to 7000 Canadians die from influenza and pneumonia. The cost of influenza to the Canadian healthcare system and economy is estimated to be more than $500 million per year, as a result of school or work absenteeism, replacement and overtime costs, hospital visits and associated health benefit costs.

Related Links: Tamiflu (oseltamivir), Hoffmann-La Roche and Gilead Sciences.

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