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FDA Approves Tiotropium Bromide HandiHaler for the Treatment of COPD

INGELHEIM, Germany and RIDGEFIELD, Connecticut, February 2/PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. has announced that the United States Food and Drug Administration (FDA) has approved Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder) for the long-term, once-daily maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD). COPD, which includes chronic bronchitis and emphysema, is a lung disease primarily caused by smoking. Spiriva(R) was discovered and developed by Boehringer Ingelheim and will be co-promoted in the U.S. with Pfizer Inc.

Spiriva(R), a novel inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva(R) works through targeting of the primary reversible component of COPD - constriction of the airways. Spiriva(R) helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators such as Spiriva(R) are the preferred treatment option for COPD maintenance therapy.

"Spiriva(R) provides significant improvements in key measures of lung function and represents a major advance in the treatment of all stages of COPD," said Dennis E. Doherty, MD, chairman of the National Lung Health Education Program and professor of medicine and chief of the Division of Pulmonary and Critical Care Medicine at the University of Kentucky Medical Center. "Spiriva(R) will become a first-line maintenance treatment for patients with mild to severe COPD. Patients may be able to control their symptoms for a full 24 hours with scheduled once-a-day use of Spiriva(R), allowing them to breathe easier, reduce their reliance on rescue medications, and help them achieve a more normal lifestyle."

In clinical trials, Spiriva(R) demonstrated significant bronchodilation that was sustained over the duration of the studies. In trials, Spiriva(R) demonstrated significant improvements in lung function over Atrovent(R) (ipratropium bromide), a current first-line therapy for COPD, which were maintained over one year. In addition, in one-year, placebo-controlled studies, patients treated with Spiriva(R) required fewer doses of rescue medications. Clinical studies both ongoing and completed include more than 9,400 patients.

Spiriva(R) was generally well tolerated. The most common adverse reaction patients reported in Spiriva(R) clinical trials was dry mouth, which was usually mild and often resolved during treatment. Constipation and increased heart rate have been reported infrequently in patients receiving tiotropium. As an anticholinergic drug, Spiriva(R) must be used with caution in patients with glaucoma and prostatic hyperplasia, as it may worsen symptoms of these conditions.

It is anticipated that Spiriva(R) will be available in retail pharmacies in the United States by the middle of this year.

Commitment to COPD
"Boehringer Ingelheim has a long-standing commitment to helping COPD patients across the globe," said J. Martin Carroll, president and chief operating officer for Boehringer Ingelheim Pharmaceuticals, Inc. , the US affiliate of Boehringer Ingelheim . "Spiriva(R) will be our greatest contribution to this therapeutic area by meeting physicians' needs for a COPD inhaled treatment that offers significant and sustained efficacy with once-daily dosing."

Spiriva(R) has been launched in more than 40 countries. Further approvals are expected in 2004 and 2005.

"Spiriva(R) represents an important breakthrough in the treatment of COPD patients," said Pat Kelly, president of U.S. pharmaceuticals at Pfizer. "We are excited to be working with Boehringer Ingelheim Pharmaceuticals on this significant medical option that will provide great value to COPD patients across America."

COPD Defined
COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function(1). The signs and symptoms patients may experience are chronic cough, excess mucus production, wheezing and shortness of breath after mild exertion. Most people with COPD are at least 40 years old or around middle age when symptoms start.

There are an estimated 24 million Americans who suffer from COPD, with over 50% under the age of 65. However, only 10 million have been diagnosed with the illness and approximately 6 million currently are receiving therapy. COPD is the fourth leading cause of death in the United States and is projected to become the third leading fatal illness by 2020. The Centers for Disease Control and Prevention estimates 119,000 Americans died of the condition in the year 20003 with fatalities for women outnumbering men for the first time. The annual cost to the nation for COPD in 2000 was estimated to be approximately US$30.4 billion. Health care expenditures accounted for US$14.7 billion, and indirect costs (decreased income due to loss of work or premature death) were US $15.5 billion.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.

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