ORLANDO, Fla., May 24 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc announced today that Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder), a new option for the treatment of patients with COPD (Chronic Obstructive Pulmonary Disease), is now being stocked in United States pharmacies and is available nationwide. Each prescription of Spiriva will include a HandiHaler inhalation device and 30 capsules, which are a one-month's supply. Spiriva HandiHaler is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Spiriva is being co-promoted in the United States by both companies.
Spiriva is the first once-daily inhaled medication to provide significant and sustained improvements in lung function for patients with COPD, a lung disease primarily caused by smoking. There are an estimated 24 million Americans who suffer from COPD, but only 10 million have been diagnosed.(1)(2) In clinical trials, Spiriva helped COPD patients breathe easier for 24 hours with each dose.
"I believe many physicians across the United States will be adding Spiriva to their prescribing regimen when treating patients with COPD because this drug has demonstrated significant improvements in key measures of lung function and was generally well tolerated in clinical trials," said Dr. Bartolome R. Celli, Chief of Pulmonary Medicine at St. Elizabeth's Medical Center in Boston. "With scheduled once-a-day use of Spiriva, patients may be able to breathe easier for a full 24 hours and use their rescue medications less."
In long-term clinical trials that included 2,663 patients (1,308 receiving Spiriva), Spiriva demonstrated significant bronchodilation (expansion of the airways) that was sustained over the duration of the studies. Spiriva also demonstrated improvements in lung function (mean FEV(1) -- Forced Expiratory Volume in one second) in two one-year clinical trials over ipratropium bromide, better known as Atrovent(R) Inhalation Aerosol, a current first-line therapy for COPD. In addition, in two one-year, and one six-month placebo-controlled studies, patients treated with Spiriva used fewer doses of rescue medications.
Spiriva HandiHaler is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment. As an anticholinergic drug, Spiriva must be used with caution in patients with narrow angle glaucoma (eye disease), prostatic hyperplasia (abnormal growth of prostate), or bladder-neck obstruction as it may potentially worsen symptoms and signs of these conditions. "Based on our experience with Spiriva in other countries, our expectation is that physicians will immediately begin prescribing Spiriva as a first-line maintenance therapy for COPD patients in the United States," said Paul Fonteyne, executive vice president for Boehringer Ingelheim Pharmaceuticals, Inc. "We feel confident that this new medicine will help millions of COPD patients."
To date, Boehringer Ingelheim and Pfizer have introduced Spiriva in more than 40 countries worldwide with over 50 million days of experience.
"With more than 14 million untreated COPD patients in the United States, we will be working with Boehringer Ingelheim to educate Americans about this deadly disease, the benefits of diagnosis and the role of Spiriva in the treatment of COPD," said Pat Kelly, president of U.S. Pharmaceuticals at Pfizer Inc.
COPD
COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.(3) 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.(4)
COPD is the fourth leading cause of death in the United States and is projected to become the third leading fatal illness globally by 2020.(3) The Centers for Disease Control and Prevention estimates 119,000 Americans died of the condition in the year 2000 with fatalities for women outnumbering men for the first time.(1) The annual economic toll of COPD in the United States in 2000 was estimated to be $30.4 billion.(3) Health care expenditures accounted for $14.7 billion, and indirect costs (decreased income due to loss of work or premature death) were $15.5 billion.(3)
More information about COPD and Spiriva is available at http://www.spiriva.com/. About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information please visit http://www.boehringer-ingelheim.com/ or http://www.spiriva.com/.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best- known consumer brands. For more information about Pfizer, please see http://www.pfizer.com/.
FULL PRESCRIBING INFORMATION AVAILABLE BY REQUEST REFERENCES 1. National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD). 2. National Heart, Lung and Blood Institute. Diseases and Conditions Index: Lung Diseases: COPD: Who is at risk? Available at http://www.nih.gov/. Accessed January 21, 2004. 3. Centers for Disease Control and Prevention. MMWR. Chronic Obstructive Pulmonary Disease Surveillance, United States, 1971-2000. August 2, 2002/51 (SS06); 1-16. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5106a1.htm. Accessed September 26, 2003. 4. Datamonitor Epidemiology and treatment Algorithm Survey. Page 12. December 2002.
Boehringer Ingelheim Pharmaceuticals, Inc.
Spiriva is the first once-daily inhaled medication to provide significant and sustained improvements in lung function for patients with COPD, a lung disease primarily caused by smoking. There are an estimated 24 million Americans who suffer from COPD, but only 10 million have been diagnosed.(1)(2) In clinical trials, Spiriva helped COPD patients breathe easier for 24 hours with each dose.
"I believe many physicians across the United States will be adding Spiriva to their prescribing regimen when treating patients with COPD because this drug has demonstrated significant improvements in key measures of lung function and was generally well tolerated in clinical trials," said Dr. Bartolome R. Celli, Chief of Pulmonary Medicine at St. Elizabeth's Medical Center in Boston. "With scheduled once-a-day use of Spiriva, patients may be able to breathe easier for a full 24 hours and use their rescue medications less."
In long-term clinical trials that included 2,663 patients (1,308 receiving Spiriva), Spiriva demonstrated significant bronchodilation (expansion of the airways) that was sustained over the duration of the studies. Spiriva also demonstrated improvements in lung function (mean FEV(1) -- Forced Expiratory Volume in one second) in two one-year clinical trials over ipratropium bromide, better known as Atrovent(R) Inhalation Aerosol, a current first-line therapy for COPD. In addition, in two one-year, and one six-month placebo-controlled studies, patients treated with Spiriva used fewer doses of rescue medications.
Spiriva HandiHaler is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment. As an anticholinergic drug, Spiriva must be used with caution in patients with narrow angle glaucoma (eye disease), prostatic hyperplasia (abnormal growth of prostate), or bladder-neck obstruction as it may potentially worsen symptoms and signs of these conditions. "Based on our experience with Spiriva in other countries, our expectation is that physicians will immediately begin prescribing Spiriva as a first-line maintenance therapy for COPD patients in the United States," said Paul Fonteyne, executive vice president for Boehringer Ingelheim Pharmaceuticals, Inc. "We feel confident that this new medicine will help millions of COPD patients."
To date, Boehringer Ingelheim and Pfizer have introduced Spiriva in more than 40 countries worldwide with over 50 million days of experience.
"With more than 14 million untreated COPD patients in the United States, we will be working with Boehringer Ingelheim to educate Americans about this deadly disease, the benefits of diagnosis and the role of Spiriva in the treatment of COPD," said Pat Kelly, president of U.S. Pharmaceuticals at Pfizer Inc.
COPD
COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.(3) 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.(4)
COPD is the fourth leading cause of death in the United States and is projected to become the third leading fatal illness globally by 2020.(3) The Centers for Disease Control and Prevention estimates 119,000 Americans died of the condition in the year 2000 with fatalities for women outnumbering men for the first time.(1) The annual economic toll of COPD in the United States in 2000 was estimated to be $30.4 billion.(3) Health care expenditures accounted for $14.7 billion, and indirect costs (decreased income due to loss of work or premature death) were $15.5 billion.(3)
More information about COPD and Spiriva is available at http://www.spiriva.com/. About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information please visit http://www.boehringer-ingelheim.com/ or http://www.spiriva.com/.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best- known consumer brands. For more information about Pfizer, please see http://www.pfizer.com/.
FULL PRESCRIBING INFORMATION AVAILABLE BY REQUEST REFERENCES 1. National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD). 2. National Heart, Lung and Blood Institute. Diseases and Conditions Index: Lung Diseases: COPD: Who is at risk? Available at http://www.nih.gov/. Accessed January 21, 2004. 3. Centers for Disease Control and Prevention. MMWR. Chronic Obstructive Pulmonary Disease Surveillance, United States, 1971-2000. August 2, 2002/51 (SS06); 1-16. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5106a1.htm. Accessed September 26, 2003. 4. Datamonitor Epidemiology and treatment Algorithm Survey. Page 12. December 2002.
Boehringer Ingelheim Pharmaceuticals, Inc.
© 2004 PR Newswire
