Boehringer Ingelheim, Pfizer to Jointly Market Once-A-Day SPIRIVA® for Chronic Obstructive Pulmonary Disease
Boehringer Ingelheim and Pfizer Inc announced today that they have entered into a long-term worldwide agreement to jointly market SPIRIVA® (tiotropium), a novel once-a-day inhaled treatment for chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema.
Boehringer Ingelheim has filed for marketing approval with regulatory authorities in Europe, where SPIRIVA® could be available as early as mid-2002. A new drug application for SPIRIVA® is anticipated to be filed with the Food and Drug Administration later this year.
SPIRIVA®, discovered and developed by Boehringer Ingelheim, would be the first once-a-day inhaled bronchodilator treatment for COPD and represents a significant advance over other treatment options.
According to the World Health Organization, about 600 million people suffer from COPD, though many are undiagnosed. The disease claims three million lives annually. It is estimated that one in five smokers will develop COPD.
“We’re very pleased to be working with Pfizer in co-promoting SPIRIVA®,” said Prof. Rolf Krebs, Chairman of the Board of Managing Directors at Boehringer Ingelheim. “Through this agreement, we gain a strong and experienced partner who will help increase awareness of the disease and of the significant patient benefits that this novel compound delivers.”
“We fully expect SPIRIVA® to be an important treatment option for a condition that is debilitating to patients and costly to health care systems worldwide,” said Pfizer Chief Executive Officer Hank McKinnell. “Building on our extensive partnering experience and combined with Boehringer Ingelheim’s established strength and long experience in respiratory disease management, SPIRIVA® should become the global leader in treating COPD.”
COPD is a chronic respiratory disorder characterized by limited airflow accompanied by symptoms such as shortness of breath, cough, wheezing and increased sputum production. As the disease progresses, patients become increasingly disabled, although at first they may attribute their symptoms to aging. Currently there are no specific medications that are fully effective in treating COPD.
Data from clinical trials involving more than 3,000 patients worldwide have demonstrated that SPIRIVA® is highly effective, providing sustained bronchodilation with significant symptomatic improvement in shortness of breath. Data also indicate that SPIRIVA® reduced exacerbations of COPD, resulting in fewer hospitalizations. SPIRIVA® also was shown to be well tolerated.
Under terms of the agreement, Boehringer Ingelheim and Pfizer will conduct additional clinical trials and further develop SPIRIVA®.
“We anticipate this will be a long and productive collaboration with Pfizer in the commercialization of SPIRIVA®,” said Dr. Alessandro Banchi, Member of Boehringer Ingelheim’s Board of Managing Directors who is responsible for pharmaceutical marketing and sales.
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