Roche Opens Full National Distribution for Seasonal Supply of Tamiflu®
Wider Flu Spread, CDC Health Alert Expected to Boost Demand
January 24, 2006 -- Nutley N.J., Roche announced today that it has lifted all restrictions on the distribution of Tamiflu® (oseltamivir phosphate) for seasonal orders and is now shipping product to all U.S. markets. Roche had previously been distributing Tamiflu only to U.S. cities where high incidence of influenza was being reported, based on the FluSTAR Surveillance System. The decision to open distribution is based on recent developments, including increased flu reports from around the country and a Health Alert issued last week by the U.S. Centers for Disease Control and Prevention (CDC), which could potentially heighten demand for Tamiflu. The CDC announced that it now recommends against the use of two antiviral medications, amantadine and rimantadine, for the remainder of the 2005–06 season, due to high levels of resistance, and that oseltamivir (Tamiflu) and zanamivir (Relenza) should be prescribed if an antiviral medication is needed.
“We are prepared to meet seasonal demand for Tamiflu, including any increase stemming from CDC’s recent announcement,” said George Abercrombie, President and CEO, Hoffmann-La Roche Inc. "We will continue to monitor the evolving environment and do everything possible to effectively manage inventory so that doctors and their patients can be assured that Tamiflu is available to them for flu treatment and prevention.”
FluSTAR (www.flustar.com) is a comprehensive, nationwide network developed to provide health care professionals and consumers with the most up-to-date information on the spread of seasonal flu.[i] According to FluSTAR, which monitors flu regionally rather than by state borders, there is high incidence of influenza in about half the country. The CDC indicates that 22 states are currently reporting either widespread or regional activity (www.cdc.gov/flu/weekly/fluactivity.htm). Influenza is widespread in New York, Texas, Arizona, New Mexico, Nevada, Colorado, Kansas, and Wyoming.
Roche implemented a proactive inventory management plan last fall, following a huge spike in Tamiflu demand that was driven by fears of a potential flu pandemic. By temporarily halting some product shipments prior to the 2005-06 flu season, Roche maintained the ability to distribute Tamiflu to U.S. markets with confirmed influenza cases, while preserving a pipeline to ensure continued availability.
The signs and symptoms of flu include high fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, and muscle aches.[ii] Stomach symptoms, such as nausea, vomiting, and diarrhea, can also occur but are more common in children than adults. If a patient suspects that he or she may have influenza, it is important to see a physician within the first 48 hours of symptom onset, as the doctor may be able to prescribe an antiviral medication to help reduce the flu’s duration and severity.
How Tamiflu Works
Tamiflu works by targeting 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. When taken within two days of the onset of symptoms, Tamiflu can reduce the duration and severity of the flu. Frequently reported adverse events include nausea and vomiting.
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have been symptomatic for no more than two days. Tamiflu is also indicated for the prophylaxis of influenza in patients one year and older.
In treatment studies in adult patients, the most frequently reported adverse events (incidence ›1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence ›1%) was vomiting. Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis.
In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence ›1%) were nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients one to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed.
Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.
For more information visit www.Tamiflu.com.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people’s health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP’s Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
[i] Data for FluSTAR (www.flustar.com) is gathered from four different surveillance methods including rapid assay data, laboratory confirmation and clinical diagnosis data.
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