Spiriva (tiotropium) is approved as a bronchodilator for the maintenance treatment of COPD. Discovered and developed by Boehringer Ingelheim, Spiriva is the first once-daily inhaled therapy for COPD.
In clinical trials, tiotropium has been proven to be superior to ipratropium bromide for the maintenance treatment of COPD based on spirometric outcome measures. The approved European label also reflects an improvement of breathlessness or dyspnea seen with Spiriva.
"We are very happy that we can now offer COPD patients an efficacious and very well-tolerated drug. In accordance with registrations received from individual health authorities and with our partner Pfizer Inc., we will introduce Spiriva worldwide over the next few years," said Prof. Rolf Krebs, chairman of the Boehringer Ingelheim’s board of managing directors.
COPD is a slowly progressive airway disease that causes significant deterioration of lung function and consequently, disability and death. Smoking is the leading cause of COPD, but exposure to pollution is another known risk factor.
While it is less well-known than asthma, COPD is far more prevalent. According to the World Health Organization, about 600 million people suffer from COPD, although many are undiagnosed. It is estimated that by 2020, COPD will be the world’s third leading cause of death.
COPD is characterized by a reduction of airflow from the lungs and an increase in air trapped inside the lungs. As more air is trapped in the lungs, the volume of the lungs increases, making air exchange very limited. A primary goal in treating COPD patients is to increase airflow and, thus, improve their ability to participate in daily activities.
Tiotropium will be marketed under the name Spiriva in a worldwide co-promotion between Boehringer Ingelheim and Pfizer Inc. Last April, the European Mutual Recognition Procedure was concluded with Spiriva being indicated as bronchodilator for the maintenance treatment of COPD.
Outside of Europe, it has been approved in a number of countries. A new drug application for tiotropium was submitted to the US Food and Drug Administration last December. Additional applications are pending worldwide.
The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. In 2001, it posted revenues of 6.7 billion euros.
The company, with some 140 affiliated companies in 42 countries, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95 percent of sales, is comprised of prescription medicines, consumer healthcare products and chemicals and biopharmaceuticals for industrial customers.
Research and development, production and distribution facilities are located around the globe. In 2001, Boehringer Ingelheim spent more than one billion euros on R&D, which is almost a fifth of the net sales of prescription medicines.
Pfizer, for its part, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world’s best-known consumer products. – PLG News & Views