Benefits of inhaled therapy for COPD cited

SAN FRANCISCO – Data from 13 scientific presentations of Boehringer Ingelheim’s tiotropium, the first once-daily inhaled therapy being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD), were presented at the 97th International Conference of the American Thoracic Society.

COPD is the world’s fourth leading cause of death with approximately three million people dying each year from the smoking-related respiratory illness.

Overall, data reveal that treatment with tiotropium may result in significant therapeutic benefit for COPD patients. Among the findings presented:

• Once-a-day administration of tiotropium in clinical trials was reported to improve lung function and symptoms over a 24-hour period. Current medications require dosing two to four times a day.

• Tiotropium reduced dyspnea, or shortness of breath, over the course of a one-year study. Dyspnea is the reason most patients seek medical attention and is a major cause of disability and anxiety associated with the disease.

• Tiotropium was effective in reducing the frequency of exacerbations in long-term studies. Exacerbations are characterized by a marked worsening in symptoms such as dyspnea, resulting in an increase in therapy and hospitalization. Exacerbations are also associated with a significant increase in healthcare resource utilization.

• New findings also indicate that tiotropium is equally effective in women as in men. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) estimates that the number of women suffering from COPD will increase significantly, reflecting rising smoking rates among women.

Prof. Romain Pauwels of the University Hospital in Ghent, Belgium said the results were "very encouraging." Presenting data on tiotropium’s effectiveness in reducing exacerbations, he said, "The findings indicate that tiotropium improved lung function of patients over a one-year period. As physicians, the overall goals of effective management of COPD include promoting smoking cessation, optimizing lung function, reducing exacerbations and improving quality of life. Tiotropium will contribute greatly to the management of this disabling disease."

"This is very important news for COPD patients," said Dr. Paul Jones of St. George’s Hospital in London, who presented health status data in COPD. "The nature of this disease is such that it imposes immense limitations on patients’ capabilities. Any improvement in their everyday quality of life will be extremely well-received," he said.

Tiotropium, currently in development, was discovered by Boehringer Ingelheim. The company has filed an application for marketing approval with regulatory authorities in Europe, where the product could be available as early as mid-2002.

In the United States, Boehringer Ingelheim plans to file a new drug application (NDA) by the end of this year. Last month, the company and Pfizer Inc. announced plans to jointly market tiotropium worldwide under the brand name Spiriva. Tiotropium could be available in the Philippine market by mid-2002.

COPD is caused primarily by smoking. The World Health Organization estimates there are currently 600 million people worldwide who suffer from COPD.

"At Boehringer Ingelheim, we are proud to have developed a product that will clearly benefit the whole COPD community," said Dr. Andreas Barner, member of Boehringer Ingelheim’s board of managing directors, responsible for research, development and medicine.

The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. In 2000, it posted revenues of more than six billion euros.

Boehringer Ingelheim, which has some 140 affiliate companies worldwide, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95 percent of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers.

Research and development, production and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost one billion euros on R&D, equivalent to 16 percent of net sales.

For more information on Boehringer Ingelheim, visit its website at www.boehringer-ingelheim.com.

Pfizer Inc. discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world’s best-known consumer products.

Pfizer had global revenues of $29.6 billion in 2000. It plans to invest about $5 billion in research and development in 2001.