New Data Show Tamiflu May Reduce Risk of Pneumonia in Flu Patients

WASHINGTON, Nov. 1 /PRNewswire/ — Treatment with the antiviral medication Tamiflu (oseltamivir phosphate) significantly reduced the risk of pneumonia in patients diagnosed with flu, according to a new retrospective cohort study of over 70,000 Americans. Reduction in pneumonia incidence was most pronounced in higher-risk groups, with a 59 percent decrease in older Americans, and a 66 percent decrease in children 12 and under. The study was presented Sunday at the InterScience Congress on Antimicrobial Agents & Chemotherapy (ICAAC) in Washington, DC.

Using a database of medical and prescription claims, researchers analyzed patients who had received a flu diagnosis during one or more seasons between 1999 and 2002. Outcomes in patients treated with Tamiflu were compared to those who had not been treated with any antiviral medication for three months prior to flu diagnosis. An analysis of three age groups, aged one and over, found:

— In patients age one – twelve, risk of pneumonia was reduced by 66

percent

— Patients 60 years and older saw a reduction of 59 percent

— In 13 – 59 year olds, risk of pneumonia was reduced by 19 percent

“The results are a significant step in understanding a potential role for Tamiflu in reducing risk of pneumonia and other sequelae of influenza,” said Dominick Iacuzio, PhD, Medical Director of Roche, which commissioned the study and markets Tamiflu, a prescription antiviral approved for the prevention and treatment of influenza. “Based on these findings, Roche is investing in two additional studies to further explore this therapeutic area.”

About the Study

Researchers measured pneumonia incidence by claims diagnosis, dispensing of an antibiotic, or hospitalization within 30 days after a flu diagnosis. In some age groups, treatment with Tamiflu also decreased incidence of antibiotic dispensing and hospitalization, though not all comparisons reach the same level of significance.

Investigators analyzed each age group separately, and accounted for numerous baseline variables using Cox proportional hazards models.

About the Flu and Pneumonia

A study published in the September 15, 2004 issue of the Journal of the American Medical Association found that more than 200,000 people are hospitalized each year because of flu-related illnesses, far more than the 114,000 annual hospitalizations previously estimated. Flu complications are more severe in people over 50 and the highest rates of hospitalizations are found in people over 85. The study also found that children under five are hospitalized at higher rates than those in the 50-64 age group. According to the U.S. Centers for Disease Control (CDC), an average of 36,000 people in the United States die from influenza each year.

While most people recover from the flu without problems, the illness can sometimes lead to serious complications, most commonly pneumonia. Pneumonia is a common illness that affects millions of people each year in the U.S. and can range from mild to severe, even fatal. The CDC cites more than 64,000 deaths from pneumonia in 2002. Most deaths occur in those who are older or whose immune systems are not working properly. Pneumonia can be caused by bacteria, viruses and fungi. Viruses including influenza A, are the second leading cause of pneumonia.

About Tamiflu

Tamiflu is an effective treatment, and can reduce the duration and severity of the flu when taken within two days of symptom onset. Tamiflu is also approved for the prevention of influenza in adults and adolescents 13 years and older. Clinical trials have also shown Tamiflu to be up to 92 percent effective in preventing influenza illness when taken once daily for at least seven days. Frequently reported adverse events include nausea and vomiting.

Tamiflu, co-developed by Roche and Gilead Sciences, Inc, 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 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.

Efficacy of Tamiflu in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

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. 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.

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. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals and diagnostics. 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 web site at: http://www.rocheusa.com/ .

Roche

CONTACT: Sue Preziotti, +1-212-453-2144 or +1-917-647-1590; or KaseyPickett, 212-453-2486, both of Fleishman-Hillard; or Terence Hurley of Roche,+1-973-562-2882, terence_j.hurley@roche.com

Web site: http://www.tamiflu.com/http://www.rocheusa.com/