NUTLEY, N.J., Jan. 4 /PRNewswire/ -- Roche announced today that it has stepped up Tamiflu(R) distribution in U.S. cities where high incidence of influenza is being reported, and will continue to meet seasonal demand for the prescription antiviral medication. Roche is shipping Tamiflu (oseltamivir phosphate) directly to wholesalers in those markets. States that have seen a particularly high increase in flu incidence recently include California, Arizona, New Mexico, Utah, Texas, Oregon, Nevada and Kansas.
Roche implemented a proactive inventory management plan last fall, following a huge spike in Tamiflu demand that was driven by fears of a potential avian flu pandemic. By temporarily halting some product shipments prior to the 2005/2006 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. Local pharmacies can order additional product from their wholesalers based on increased demand, ensuring that Tamiflu is available to patients with a doctor’s prescription.
“When demand for Tamiflu rose last year, Roche took appropriate precautions to ensure adequate supplies would be available for the treatment and prevention of seasonal influenza,” said George Abercrombie, President and CEO, Hoffmann-La Roche Inc. “Because of those precautionary measures, Tamiflu is readily and widely available to patients who need it for flu treatment and prevention, while we continue to work with governments to supply stockpiles for pandemic preparedness.”
Under the company’s plan, Tamiflu will continue to be shipped where it is needed, based on increased incidence of influenza activity as tracked by FluSTAR (http://www.flustar.com), 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.(1)
Flu Symptoms
The signs and symptoms of flu include high fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, and muscle aches.(2) 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. To learn more about flu symptoms and track spread of the influenza virus in the U.S., visit http://www.flustar.com.
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.
About Tamiflu
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). The leading prescription oral antiviral drug, Tamiflu is indicated for treatment of type A and B influenza in patients one year and older. Tamiflu is an effective treatment, and can reduce the duration and severity of the flu when taken within two days of symptom onset. Tamiflu, a neuraminidase inhibitor, works by attacking the influenza virus and its ability to replicate, rather than simply addressing influenza symptoms.
Tamiflu is also approved for the prevention of influenza in adults and children one year and older. Clinical trials have shown Tamiflu is effective in preventing influenza illness when taken once daily for at least ten days. For the prevention of influenza in those 13 years or older, Tamiflu is administered following close contact with an infected individual who demonstrates characteristic symptoms of influenza, and based on knowledge that influenza is circulating in the area for 10 days, or up to six weeks for seasonal prophylaxis. For the prevention of influenza in children age one to 12, Tamiflu is administered for 10 days following close contact with an infected individual.
Tamiflu is generally well tolerated. In treatment studies in adults, the most frequently reported adverse events were mild-to-moderate transient nausea and vomiting. Other events reported more frequently than with placebo were bronchitis, insomnia and vertigo. In prophylaxis studies in patients aged 13 and older, adverse events were qualitatively similar to those seen in the treatment studies despite a longer duration of dosing. Events reported more frequently in subjects receiving Tamiflu compared to subjects receiving placebo in prophylaxis studies included nausea, vomiting, diarrhea, abdominal pain, dizziness, insomnia, headache, vertigo and fatigue.
In pediatric treatment 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. Adverse events in pediatric prophylaxis studies were consistent with those observed in pediatric treatment studies.
Rare cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnsons syndrome, and erythema multiforme have been reported in post-marketing experience with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected.
Efficacy of Tamiflu in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established.
Tamiflu was approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated acute illness due to influenza infection in adults in October 1999. The FDA granted marketing approval for the prevention of naturally occurring influenza A and B in adults and adolescents 13 years and older in November 2000. The FDA granted marketing approval of the oral suspension for use in the treatment of influenza A and B in children one year and older in December 2000. In December 2005, the FDA extended the prophylaxis indication for Tamiflu to children age one to 12 years. Tamiflu oral suspension is used for pediatric patients one year and older or adult patients who cannot swallow a capsule. Tamiflu is the first and only liquid suspension to treat influenza A and B.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 40 countries worldwide. For more information visit http://www.Tamiflu.com
About Roche
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, 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 http://www.roche.us.
(1) Data for FluSTAR (http://www.flustar.com) is gathered from four different surveillance methods including rapid assay data, laboratory confirmation and clinical diagnosis data. (2) http://www.cdc.gov/flu/keyfacts.htm
Roche
CONTACT: Terence Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com; or Sue Preziotti of Fleishman-Hillard,+1-212-453-2144, preziots@fleishman.com
