News Release

First national tracking system to measure and predict peaks for common respiratory tract infections launched

Peer-Reviewed Publication

Chandler Chicco Agency

Weekly updates via internet and toll-free line predict when peak RTI season will hit local areas

Bayer sponsors respiratory tract infection alert to provide U.S. with about two weeks advance warning

West Haven, CT, October 26, 2000 –The Respiratory Tract Infection Alert, America’s first national tracking system to give consumers direct access to proprietary information on respiratory tract infection (RTI) rates in their area, was launched today. The RTIalert, which is sponsored by Bayer Corporation, maker of Avelox® (moxifloxacin, HCl) tablets, provides predictive information via the Internet and a toll-free number to let people know if their hometown will be hit hard with RTIs this season.

The RTIalert provides RTI incidence data from a sample of approximately 30,000 physicians, gleaned from data encompassing 85-100 million outpatient visits in 72 markets per year. RTIalert readings are reported on a scale of 0 to 10, with 10 indicating the highest incidence of RTIs in that particular area.

Top 10 U.S. Cities Hardest Hit by RTIs last winter According to an RTIalert analysis of last year’s incidence data, the ten U.S. cities hardest hit by respiratory tract infections during the 1999 – 2000 RTI season (October – March) were: Orlando (with a yearly average of 6.44), Oklahoma City (6.03), Columbus (6.02), Tampa (5.89), Atlanta (5.81), Milwaukee (5.74), Philadelphia (5.69), Des Moines (5.64), Memphis (5.58), Greenville (5.51). The national RTIalert average over the season was 4.65.

The RTIalert

The RTIalert tracks common respiratory tract infections such as bronchitis, sinusitis and pneumonia.

Beginning this week, consumers can check the RTIalert in their area by logging onto www.RTIalert.com or by calling the Bayer RTIalert toll-free line at 1-866-RTI-INFO (1-866-784-4636) and entering their zip code. 1 These services will also offer a free brochure on RTIs as well as tips for staying well or for getting better.

RTIs cause aches, pains and unproductive days for millions of adults each year. In many cases, the symptoms of these conditions are similar to a cold or flu, causing confusion about whether to see a doctor for diagnosis and treatment. When RTIs are left untreated symptoms and discomfort may linger longer than necessary.

"In addition to making life miserable, some RTIs can pose more serious health risks if not diagnosed and treated promptly," said Paul Iannini, M.D., Clinical Professor of Medicine, Yale, Chairman, Department of Medicine, Danbury Hospital, and scientific advisor to the RTIalert. "Because data from the RTIalert can predict the whereabouts of outbreaks, physicians can be forewarned to the potential threat of these diseases for their patients."

Licensed to Bayer by Surveillance Data Inc. (SDI), an independent research firm, the RTIalert provides a highly-customized data system to track respiratory infections by closely monitoring doctors’ diagnoses of RTIs. The RTIalert data are collected and analyzed by SDI, which uses several modeling techniques to determine both the current levels of infection and a prediction of what the those levels will be in the weeks ahead.

Weekly Updates

During each week of the RTI season, the web site and toll-free line will be updated with the national RTI trends, indicating both the current rate of RTIs across the country and a prediction for the coming weeks. The RTIalert will also track the rate of infection from one year to the next on a national and local level.

"Bayer has helped millions who suffer from common RTIs," said Deborah Church, M.D., Director, Anti-infectives Medical Research, Bayer Corporation. "Now, we’re hoping that the RTIalert will provide valuable information about the trends of RTIs in this country and also inform those prone to these conditions just when outbreaks are likely to strike their area."

Understanding Common Adult RTIs

Respiratory tract infections may be caused by bacterial, viral or fungal organisms which invade the respiratory tract and can cause individuals to feel tired, achy and sick enough to miss daily activities for several days2. Acute exacerbations of chronic bronchitis (AECB), sinusitis and community acquired pneumonia (CAP) are three common RTIs that can really slow adults down.

Acute Exacerbations of Chronic Bronchitis

Bronchitis is an inflammation of the lining of the major breathing tubes (called bronchial tubes or bronchi) that connect the windpipe (or trachea) to the lungs.3 Chronic bronchitis is a condition in which the patient has symptoms including cough, excessive phlegm (or mucus) production, and/or shortness of breath for three months of the year for at least two consecutive years.4 Chronic bronchitis is often neglected by sufferers who mistakenly believe exacerbations, or flare-ups, are remnants of a winter cold. A smoker with such flare-ups may dismiss them as "smoker’s cough."5

Sinusitis

Sinusitis is an inflammatory disease of the sinus. One of the most commonly reported diseases in the United States, it affects an estimated 35 million people and accounts for more than 11.5 million visits to the doctor each year.6 Symptoms of acute bacterial sinusitis may initially appear to be residual of a cold or an allergy attack but become more severe and last for a period of time. They include: excessive production of thick, sticky, yellow-green mucus, or mucus that develops a bad odor or taste; severe pressure and pain in the face and forehead; coughing, and nasal congestion lasting more than 10 to 14 days. 7

Community Acquired Pneumonia

CAP, the most common form of pneumonia, is an acute infection of the lung tissue occurring in a person who has not been hospitalized for at least 14 days before symptoms occur (hence "community-acquired"). 8 The symptoms of CAP include coughing with or without phlegm production, chest pain, shortness of breath, chills, shaking and/or fever.9

About Avelox®

Avelox is indicated for acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial sinusitis, and community acquired pneumonia of mild to moderate severity (CAP), caused by indicated susceptible organisms. The recommended therapeutic dose for Avelox is 400 mg taken once daily for five days for ABECB and for ten days for CAP and acute bacterial sinusitis.

Important Safety Information

Avelox® is generally well tolerated. In clinical trials, the most common adverse events were nausea (8%), diarrhea (6%), dizziness (3%), headache (2%), abdominal pain (2%), and vomiting (2%). Avelox is contraindicated in persons with a history of hypersensitivity to Avelox or any quinolone antibiotic. The safety and effectiveness of Avelox in pediatric patients, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established. Avelox has been shown to prolong the QT interval of the electrocardiogram in some patients. The drug should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and patients receiving Class lA (e.g., quinidine, procainamide) or Class lll (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations. Pharmacokinetic studies between Avelox and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of Avelox and these drugs cannot be excluded; therefore, Avelox should be used with caution when given concurrently with these drugs.

The effect of Avelox on patients with congenital prolongation of the QT interval has not been studied; however, it is expected that these individuals may be more susceptible to drug-induced QT prolongation. Because of limited clinical experience, Avelox should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, or acute myocardial ischemia.

As with all quinolones, Avelox should be used with caution in patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.

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For full prescribing information, log on to http://www.aveloxusa.com/patient.html. Bayer Corporation

Bayer Corporation is a research-based company with major businesses in health care and life sciences and chemicals. The company had 1998 sales of $8.1 billion and employs more than 23,000 people. Bayer Corporation is investing $15 billion in capital expenditures and research and development from 1995 through the year 2004. 1999 capital investment and R&D expenditures are projected to total $1.6 billion. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion international life sciences, polymers and specialty chemicals group based in Leverkusen, Germany.


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