June 26, 2002
Roche Receives Approval in Europe for Tamiflu(R)
- Oral Antiviral Medication for the Treatment and Prevention of Influenza in Adults, Children Approved for Marketing -
"Access to new antivirals such as Tamiflu is important for physicians and patients. It means that the medical profession will have a new weapon to fight the influenza virus, which affects many people every year in Europe, knocking them flat," commented Professor John Oxford, Barts and The London, Queen Mary's School of Medicine and Dentistry, London, UK.
In Europe, influenza can affect up to one in ten adults in a normal year, and this number can increase significantly during severe epidemics. In the United Kingdom, about 20,000 people died as a result of influenza and its complications in 2000. In the U.S., approximately 30 to 40 million Americans contract the flu virus each year.
"During past flu seasons in the U.S., antivirals, such as Tamiflu, helped my patients decrease the duration of their flu bout," said Donald B. Perlman, M.D., Practicing Physician, Clinical Assistant Professor, University of Medicine of New Jersey. "It is promising to see that this advancement in influenza treatment will now be available to a wider audience in Europe."
Tamiflu is available for the treatment of influenza in over 40 countries worldwide, including the United States, Japan, Australia, Canada, Korea, Switzerland and many Latin American countries. Around four million patients have been treated with Tamiflu since launch. It is also approved in the U.S. for the prevention of influenza in adolescents and adults, and in the U.S. and Canada for the treatment of influenza in children aged 1 year and above.
Tamiflu was co-developed by Gilead Sciences, Inc, USA, and is a systemic treatment for the most common strains of influenza (types A and B). The medication targets one of the two major surface structures of the influenza virus, the neuraminidase protein. The neuraminidase site is virtually the same in the most common strains of influenza, types A and B. Tamiflu attacks the influenza virus and is thought to work by stopping it from spreading inside the body. Tamiflu treats flu at its source, by attacking the virus that causes the flu, rather than simply masking symptoms.
Tamiflu is generally well tolerated. In treatment studies for adults, the most frequently reported adverse events were mild-to-moderate transient nausea or vomiting. Other events reported more frequently than with placebo were bronchitis, insomnia and vertigo. In prophylaxis studies, adverse events were qualitatively similar to those seen in the treatment studies despite a longer duration of dosing. The most frequently reported adverse events were nausea, vomiting and headache. Other events reported more frequently than with placebo were diarrhea, abdominal pain, dizziness, insomnia, vertigo and fatigue. However, the difference in incidence between Tamiflu and placebo for these events was less than one percent. In pediatric studies, the most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric patients treated with Tamiflu included abdominal pain, epistaxis, ear disorder and conjunctivitis. These events generally occurred once and resolved despite continued dosing. In clinical trials, for flu patients taking Tamilfu compared to placebo, there was a 1.3 day reduction in the median time to flu symptom improvement.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United States, visit the company's website at: http://www.rocheusa.com
About Gilead Sciences, Inc.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has five marketed products and focuses its research and clinical programs on anti-infectives, including antivirals, antifungals and antibacterials. Headquartered in Foster City, CA, Gilead has operations in the United States, Europe and Australia. For more information regarding Gilead Sciences, visit the company's web site at http://www.gilead.com.
EDITOR'S NOTE: For more information on Influenza Consumers can call 1-800-I-GOT-FLU (1-800-446-8358) or log on to http://www.tamiflu.com. To learn about Influenza surveillance and to find out if flu is in your area, log on to http://www.flustar.com.
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