Study Shows that Spiriva^® Plus Foradil^® is More Effective in Improving Lung Function Than Serevent^® Plus Flovent^®

- Results of Head-to-Head Study Reinforce the Value of Bronchodilator Treatment in Emphysema and Chronic Bronchitis -

COPENHAGEN, September 21, 2005 - Study results presented Sunday show that treatment with Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder) plus Foradil^® (formoterol MDI)* provided greater improvements in key lung-function measures than treatment with Serevent^®** (salmeterol MDI) plus Flovent^®** (fluticasone propionate MDI) in patients with chronic obstructive pulmonary disease (COPD). These findings were announced at the 15th Annual Congress of the European Respiratory Society.

The study is the first prospective trial to evaluate two long-acting bronchodilators taken together versus a bronchodilator plus an inhaled corticosteroid in COPD patients. In treating COPD patients, current guidelines from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommend long-acting bronchodilator combinations prior to those with a bronchodilator and an inhaled corticosteroid.¹This study reinforces guideline recommendations to maximize bronchodilation before adding an inhaled corticosteroid.

SPIRIVA, Foradil and Serevent belong to two classes of long-acting inhaled bronchodilators - anticholinergics (SPIRIVA) and beta-agonists (Foradil and Serevent) - both of which are indicated for the long-term maintenance treatment of COPD.² Flovent is an inhaled corticosteroid. All three drug classes are used in different combinations to help enhance lung function, enabling COPD patients to breathe better.³ SPIRIVA is a once-daily, long-acting bronchodilator with no steroid components. It is indicated for the long-term maintenance treatment of bronchospasm associated with COPD, which includes chronic bronchitis and emphysema.⁴

"These results point to the potential of the SPIRIVA and Foradil combination to effectively manage patients with moderate-to-severe COPD," said Dr. Donald Tashkin, Professor of Medicine, David Geffen School of Medicine at UCLA. "Maximizing lung function is the key to helping COPD patients breathe easier; consequently, research is ongoing to evaluate treatment combinations that can optimize effectiveness. Inhaled bronchodilators are a cornerstone of COPD treatment, and these study findings reinforce the value of using them in combination to effectively manage patients with this condition."

Results from this six-week, double-blind, comparative trial of 592 patients showed that patients treated with SPIRIVA in combination with Foradil experienced greater improvements in key lung-function measures than those treated with Serevent and Flovent.⁵ More specifically, over the course of the six-week study period, the average Forced Expiratory Volume (FEV₁ -- forced expiratory volume in one second) over 12 hours was greater among patients treated with Spiriva and Foradil than those who received Serevent and Flovent (1.641L vs. 1.563L, p=0.0006).⁶ Further, the peak FEV₁ response was 1.775L in the Spiriva and Foradil arm⁷ vs. 1.672L in the Serevent and Flovent arm (p<0.0001).⁸ Also, patients receiving SPIRIVA and Foradil showed greater Forced Vital Capacity (FVC) response and peak FVC measurements over the 12-hour period (an increase of 173mL)⁹ and throughout the study period (an increase of 79mL) respectively.¹⁰ In both arms, pre-dose FEV₁ improved after eight weeks of treatment, but the difference between the two groups was not statistically significant.

"Improvements in forced expiratory volume and forced vital capacity are significant because they illustrate the therapeutic value of the combination of SPIRIVA and Foradil in helping patients get air in and out of their lungs so they may breathe easier," noted Dr. Tashkin.

In this trial, both regimens were well tolerated.¹¹ The most commonly reported adverse events included COPD exacerbation, pharyngitis and cough.¹²

This study, sponsored by Boehringer Ingelheim and Pfizer, Inc evaluated patients with moderate COPD as outlined by the GOLD criteria.¹³ Patients enrolled in this trial were randomized to receive either Spiriva 18µg once daily plus Foradil 12µg twice daily (n=297) or Serevent 50µg twice daily plus Flovent 500µg twice daily (n=295).¹⁴ To achieve blinding, patients in this study inhaled four different devices in the morning and three in the evening.¹⁵ The co-primary endpoints were average FEV₁ over a 12-hour period and peak FEV₁ measured at the end of six weeks of treatment.¹⁶

About COPD

COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.¹⁷ The symptoms that patients may experience include chronic cough, excess mucus production, wheezing and shortness of breath even after mild exertion or at rest.¹⁸ COPD is often associated with exacerbations of these symptoms,¹⁹ which can account for a high proportion of health-care costs associated with this disease.²⁰ An expert panel convened by GOLD - including the National Heart, Lung, and Blood Institute and World Health Organization - assigned a high priority to clinical research that might improve the management of COPD.

COPD is primarily caused by cigarette smoking; it affects both current and former smokers. Other causes of the disease include exposure to industrial dusts and chemicals.²¹ Researchers have found a link between COPD and a genetic disorder involving a deficiency in the enzyme alpha1-antitrypsin (AAT) that normally prevents loss of the lungs' elastic fibers.²²

An estimated 24 million adults in the United States have impaired lung function, but only about 10 million have been diagnosed with COPD.²³ COPD is the fourth-leading cause of death in the United States and the only leading cause of death currently on the rise - it's projected to become the third-leading cause of death by 2020.²⁴ It is also the second-leading cause of disability in the United States.²⁵

About SPIRIVA HandiHaler SPIRIVA

HandiHaler (tiotropium bromide inhalation powder) is a once-a-day, regular (maintenance) treatment for bronchospasm (airway narrowing) associated with COPD, including chronic bronchitis and emphysema. SPIRIVA is contraindicated in patients with a hypersensitivity to atropine or its derivatives - i.e., ipatropium or any components of this product. SPIRIVA is not for treating sudden breathing problems. The most common side effect is dry mouth. It is usually mild and goes away with continued use.26

Please see www.spiriva.com for full prescribing information.

Consumers who need help paying for medicine, or who know someone who needs help, can call 1-888-4PPA-NOW (1-888-477-2669) or go to www.pparx.org.

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 144 affiliates in 45 countries and nearly 36,000 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 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

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 products. For further information on Pfizer, please see www.pfizer.com.

*Foradil is a registered trademark of Schering-Plough and Novartis
**Serevent and Flovent are registered trademarks of GlaxoSmithKline Inc.

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Contacts:

Boehringer Ingelheim Pharmaceuticals, Inc.
Lara Crissey
Phone: 203-798-4740
lcrissey@rdg.boehringer-ingelheim.com

Pfizer Inc
Paul Ewing
212-733-0179 (office)
917-715-1547 (mobile)

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