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Title: Canada Approves Relenza, An Inhaled Treatment For The Flu
URL: http://www.pslgroup.com/dg/14201A.htm
Doctor's Guide
November 4, 1999


TORONTO, ON. -- November 4, 1999 -- Just in time for this year's flu season, the Therapeutic Products Program of Health Canada has approved a revolutionary new flu treatment which experts are hailing as a major breakthrough in the fight against flu. Relenza™ (zanamivir) is the first anti-viral medication that is active against all strains of the flu virus. Taken as an inhaler, Relenza directly targets the flu virus in the respiratory tract and significantly reduces the duration and severity of symptoms associated with flu.

"The neuraminidase class of new flu drugs ought to change the way we see influenza in Canada," said Dr. Fred Aoki, influenza researcher at the University of Manitoba and a triallist for Relenza. "Canadians should no longer think of flu as something they have to put up with. People who have flu and take Relenza will have flu for a much shorter time, have fewer symptoms and be up and functioning much sooner."

Relenza is the first in a new class of anti-viral drugs called neuraminidase inhibitors. Neuraminidase is an enzyme which the virus needs in order to spread and infect other healthy cells in the respiratory tract. Delivered directly to the respiratory tract where the virus resides, Relenza inhibits the action of neuraminidase and helps prevent the virus from spreading and infecting other healthy cells. Clinical studies show that Relenza not only reduces the duration of flu but also significantly reduces symptoms. Some studies have also shown reduction in associated complications such as pneumonia.

"We are very proud to bring to Canada the first ever inhaled flu medication that is active against all known flu strains," said Michael Levy, Senior Vice President of Research and Development and Chief Medical Officer at Glaxo Wellcome Inc. "Each year, flu affects millions of Canadians, causes over 70,000 hospitalizations and claims nearly 7,000 lives. Flu-related costs to the Canadian economy are over $1 billion annually. Relenza will significantly lessen this tremendous health care and economic burden."

Relenza is inhaled via a device similar to an asthma "puffer". Taken twice daily for five days, Relenza quickly achieves high concentrations of medication in the lungs, particularly on the surface of the respiratory tract where the virus replicates. Being able to switch off viral replication early on, when the flu virus is at its peak, not only shortens the duration of the flu, but also gets people back to normal functioning much sooner.

"Relenza is the result of years of painstaking research aimed at identifying ways to attack this virus," said Levy. "Although flu sufferers feel symptoms all over, the virus itself is confined to the respiratory tract. Recognizing that the flu 'bug' is primarily in the respiratory tract, scientists designed Relenza as an inhaled medication so that it would reach the site of infection faster, rapidly shutting down the flu with minimal side effects."

Clinical studies with over 6,000 patients worldwide show that Relenza is well tolerated, with a safety/tolerability profile similar to placebo. "A favourable side effect profile is key," said Dr. Allison McGeer, Director of Infection Control at Mount Sinai Hospital. "The flu can make you feel just awful and the last thing you want to have is treatment-related side effects on top of your flu symptoms."

Flu is often confused with the common cold, and it is important to know the difference in order to seek the appropriate treatment. While flu and the common cold share many respiratory symptoms such as nasal congestion, cough and sore throat, flu also typically produces an abrupt onset of fever, muscle aches and pains, chills and headache. Colds generally last five to seven days while flu lasts up to 10 days.

For maximum benefit, flu sufferers must begin Relenza treatment within the first two days of symptom onset. They are advised to visit a walk-in-clinic or obtain an appointment with their family physician if they require treatment; they are not advised to visit the emergency department of their local hospital seeking Relenza treatment.

Relenza will cost $35 (plus the pharmacist dispensing fee) for a five-day treatment of two daily doses and will be available in pharmacies across the country by the beginning of December.

Glaxo Wellcome has requested that the provincial governments of Canada include Relenza on their formularies of reimbursed drugs in time for the 1999-2000 flu season. Relenza has been approved in the United States, European Union, Australia, New Zealand, Mexico, Armenia and now in Canada.

Relenza was developed in Australia in the 1980s and licensed to Glaxo Wellcome by Biota Holdings, an Australian pharmaceutical research and development company. The agreement provides Glaxo Wellcome with the right to develop and market Relenza worldwide.

Relenza™ is a registered trademark of Glaxo Group Limited, Glaxo Wellcome Inc., licensed use.

Influenza occurs every year and affects 10 to 15 percent of the population, or three to five million Canadians. This number can be as high as 80 percent in nursing homes.

Both flu and colds are highly contagious respiratory infections caused by viruses. Although both illnesses result in increased use of healthcare resources and lost productivity, flu produces severe symptoms that can lead to pneumonia and even death in high-risk patients (e.g., the elderly and those with respiratory and heart disease).

Vaccines are used before the beginning of the flu season based on recommendations from public health authorities. Immunity from a specific strain typically lasts four to six months. Relenza is a complementary treatment-and not a replacement-to vaccination.

Related Links: Relenza (zanamivir) andGlaxo Wellcome Inc.

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