Press Releases
January 18, 2001
Pharmacy Shelves Make Room for Tamiflu™ Liquid for Kids
-- Tamiflu™ (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza, now in stores to treat children one year and older --
NUTLEY, NJ -- January 18, 2001
Hoffmann-La Roche Inc. announced today that the liquid formulation for the pediatric treatment indication for Tamiflu™ (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza in adults, began arriving in pharmacies the week of January 15, 2001. This new liquid suspension, used for the treatment of acute illness due to influenza types A and B in children 1 year and older, can also be used for adults who cannot swallow a capsule, particularly the elderly, including residents of nursing homes and long term care facilities.
The U.S. Food and Drug Administration (FDA) granted Roche marketing approval for a pediatric treatment indication for Tamiflu on December 14, 2000. Tamiflu is the first and only liquid suspension to treat the most common strains of influenza (types A and B).
“With flu arriving late this season, the availability of Tamiflu for children is timely as influenza surveillance systems, like FluSTAR.com, are now starting to report several flu outbreaks across the country,” said Keith Reisinger, M.D., Pittsburgh Pediatric Research and investigator in the pediatric trials of Tamiflu. “Flu surveillance systems are also reporting an increase in the number of confirmed flu B isolates over last year, making it important for patients, both adults and children, to be treated with an antiviral that attacks influenza A and B.”
Pediatric clinical studies show that Tamiflu reduced the duration of influenza by 1.5 days (26 percent) in children aged 1-12 when given within two days of onset of symptoms. Children were administered Tamiflu in a tutti-frutti flavored oral suspension formulation.
In discussing these results, Dr. Reisinger said, “The incidence of influenza in children is significantly higher than in healthy adults. However, up until now, treatment of influenza A and B has not been available for all ages of children. Given Tamiflu's convenient mode of administration and good safety profile, it will fill a previously unmet medical need and be of great use to pediatricians during the winter flu season.”
Tamiflu was well tolerated. The most common adverse event in the pediatric study was vomiting (approximately 5 percent higher than the placebo group). Other events reported more frequently included abdominal pain, epistaxis, ear disorder, and conjunctivitis. These events generally occurred once, despite continued dosing, and only 8 patients (2 percent) withdrew from this study due to adverse events. Tamiflu is not a substitute for a flu vaccination. You should continue to get a flu vaccination every year, according to your health care professional’s advice.
Serious bacterial infections may begin with influenza-like symptoms or may co-exist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications.
"The treatment benefit of Tamiflu in children is consistent with what is seen in the adult population, and is particularly exciting because of the high incidence of flu in children," said Dr. Dominick Iacuzio, Medical Director, Hoffmann-La Roche. "The pediatric indication builds on the Tamiflu franchise and further demonstrates Roche’s commitment to influenza management."
About FluSTAR™
To determine the location and spread of influenza in local areas, physicians and consumers can log on to www.flustar.com. FluSTAR™ is a new surveillance system that provides timely and reliable reporting of flu activity on a regional and nationwide basis. FluSTAR is unique because it provides a quick and more localized measurement of influenza disease than current laboratory culture-based surveillance networks.
The most powerful component of the FluSTAR system is a rapid flu test that detects influenza antigen in an outpatient setting. It is the only surveillance system that combines the results of a rapid flu test with three other data components to measure flu activity in a local area.
About Tamiflu™
Tamiflu (oseltamivir phosphate), co-developed with Gilead Sciences (NASDAQ:GILD) of Foster City, California, is a systemic treatment for the most common strains of influenza (types A & B) and is available in convenient pill and liquid formulations. Tamiflu was approved by the U.S. Food and Drug Administration in October 1999 for the treatment of uncomplicated influenza in adults and is now the market leader in antiviral influenza treatment. In its first season of availability for treatment, Tamiflu amassed more than 58 percent of the market share within the class of antivirals called neuraminidase inhibitors, and garnered more than 30 percent of the overall influenza antiviral market. In November 2000, Roche received marketing approval for a prophylaxis indication for Tamiflu in adolescents and adults.
About Hoffmann-La Roche and Gilead Sciences
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: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases, including obesity and diabetes. For more information on the Roche pharmaceuticals business in the United States, visit the company’s web site at: www.rocheusa.com. To learn about influenza surveillance and to find out if flu is in your area, log onto www.flustar.com.
Gilead Sciences, Inc., headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in the United States, Europe and Australia. For more information about Gilead, please visit www.gilead.com.
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