New SPIRIVA(R) Respimat(R) Inhaler Completes European Approval Process for COPD

Ingelheim, Germany (ots/PRNewswire) -

- Patients to Benefit From Easy-to-Use Inhaler With Enhanced Drug
Delivery

Boehringer Ingelheim and Pfizer today announced successful
completion of the approval process for authorisation to market
SPIRIVA(R) Respimat(R) in the European Union for people with chronic
obstructive pulmonary disease (COPD). This positive opinion for the
SPIRIVA(R) Respimat(R) is the cornerstone of all national approvals
in 25 countries of the European Union. SPIRIVA(R) Respimat(R) is a
propellant-free, new generation inhaler that combines innovative
technology with the proven efficacy of SPIRIVA(R) (tiotropium).(1)

"SPIRIVA(R) Respimat(R) represents a major step forward in COPD
and inhalation therapy. Many patients find certain inhaler devices
difficult to coordinate and use," said Professor Marc Decramer,
Respiratory Division, University Hospitals, Katholieke Universiteit
Leuven, Belgium. "SPIRIVA(R) Respimat(R) has a unique and
sophisticated delivery system, and a user friendly design, making it
easy to use and suitable for a broad range of patients with COPD. In
addition the long-lasting, soft mist cloud generated by SPIRIVA(R)
Respimat(R) ensures optimised delivery of SPIRIVA(R) to the lungs,
helping patients breathe more easily," he added.

In clinical studies comparing inhaler devices,(1) patients
preferred Respimat(R) Soft Mist(TM) Inhaler, which may help increase
patient compliance with therapy.(2),(3),(4),(5) The novel
dose-delivery system of the SPIRIVA(R) Respimat(R) also means that
unlike dry powder inhalers, the dose delivered is not dependent on
patients' inspiratory flow.

SPIRIVA(R) (tiotropium), a first-line maintenance therapy for
COPD, positively impacts the clinical course of the disease, helping
to change the way patients live with their condition.(6),(7) The
efficacy of SPIRIVA(R) has been demonstrated by an extensive clinical
development programme, which has treated over 25,000 patients.(1) It
is the most prescribed brand in COPD in the world.(8)

The SPIRIVA(R) Respimat(R) delivery system relies on energy
released from a spring, rather than propellants, to produce a
long-lasting, slow moving Soft Mist(TM). The innovative design makes
SPIRIVA(R) Respimat(R) easy to use, and the Soft Mist(TM) results in
improved delivery of SPIRIVA(R) to the lungs, with reduced deposition
in the mouth and throat compared to a pressurised metered dose
inhaler (pMDI). One study showed that 72% of all patients use pMDIs
incorrectly and almost half (47%) have problems with coordinating use
of the device.(9)

600 million people worldwide live with COPD and its prevalence is
predicted to rise making it the world's third leading cause of death
by 2020.(10),(11) It is estimated that up to 50% of Americans and 75%
of Europeans with COPD are undiagnosed.(12),(13)

Dosing

SPIRIVA(R) Respimat(R) 2.5 microgram (total 5 microgram dose
administered as 2 x 2.5 microgram puffs) has a therapeutic effect
comparable to SPIRIVA(R) HandiHaler(R) 18 microgram.(14) SPIRIVA(R)
Respimat(R) is a convenient, multi-dose device with a dose indicator
and can provide treatment for one month.

Please be advised

This release is from the Corporate Headquarters of Boehringer
Ingelheim and Pfizer and is intended for all international markets.
This being the case, please be aware that there may be some
differences between countries regarding specific medical information
including licensed uses. Please take account of this when referring
to the material.

Notes to Editors

Advanced technology; simple operation

To use the SPIRIVA(R) Respimat(R) patients simply need to twist
the base of the inhaler 180 degrees. This action compresses the
spring, which results in a pre-defined, metered volume of solution
being drawn up through the capillary tube and into a micro-pump. The
Soft Mist(TM) is generated by the use of principles established for
microchip technology which enables fine fluid channels to be etched
into the surface of silicon wafers. These are then covered by a glass
plate and bonded chemically. This filter structure known as a
uniblock, results in two extremely fine outlet channels, through
which SPIRIVA(R) is forced, producing two ultra fine jets of liquid
that converge at a carefully controlled angle. The impact of these
two jets converging is what creates the unique Soft Mist(TM). Once
the dose-release button is pressed, the energy released from the
spring forces the solution through the uniblock and the slow-moving,
long-lasting Soft Mist (TM) is released.

About SPIRIVA(R) (tiotropium)

SPIRIVA(R), a long-acting inhaled anticholinergic medication, is
the first inhaled treatment to provide significant and sustained
improvements in lung function with once-daily dosing. SPIRIVA(R)
positively impacts the clinical course of COPD, helping to change the
way patients live with their disease.(6),(7) It is the most
prescribed medication for the treatment of COPD in the world.(8)

SPIRIVA(R) works through targeting of a dominant reversible
mechanism of COPD - cholinergic bronchoconstriction.(15),(16)
SPIRIVA(R) helps COPD patients breathe easier by opening narrowed
airways and helping to keep them open for 24 hours.

The SPIRIVA(R) clinical programme has recruited over 25,000
patients.(1) SPIRIVA(R) has demonstrated significant and sustained
bronchodilation (opening of the airways)(7),(16) and reduction in
hyperinflation (air trapping).(15),(17) SPIRIVA(R) also demonstrated
superior and sustained improvements in lung function (FEV1) over
ipratropium bromide (ATROVENT(R)) Inhalation Aerosol, a current
first-line therapy for COPD, which were maintained over one year(7)
and has also demonstrated superior improvement in key lung function
parameters over salmeterol.(18) In addition, in placebo-controlled
studies, patients treated with SPIRIVA(R) had less activity-induced
breathlessness and improved exercise endurance.(6), (19) They
required fewer doses of rescue medications, had fewer exacerbations
and COPD-related hospitalizations.(16) In clinical trials, the most
common adverse reaction reported with SPIRIVA(R) was dry mouth,
which was usually mild and often resolved during treatment. (7),
(16) Long-acting bronchodilators, including SPIRIVA(R), are a
preferred maintenance therapy for COPD from stage II onwards
according to the Global Initiative for Chronic Obstructive Lung
Disease (GOLD) treatment guidelines.(20)

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 137 affiliates in 47 countries and 38,400
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 2006, Boehringer Ingelheim posted net sales of 10.6 billion
Euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.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 products. For further information on
Pfizer, please see www.pfizer.com

Contact:
Boehringer Ingelheim GmbH
Ute E Schmidt
Corporate Division Communications
55216 Ingelheim am Rhein
GERMANY
Phone: +49-6132-77-97296
Pfizer Inc
Francisco Gebauer
Corporate Media Relations
235 East 42nd street
New, York, NY
USA
Phone: +1-212-733-5191

Graphics, photos and data for feature articles are available on
request.

References

- (1) Hydrofluoroalkane Metered Dose Inhaler, Turbuhaler(R),
Diskus(R)

- (1) Data on file. Ingelheim, Germany: Boehringer Ingelheim
International GmbH.

- (2) Hodder R. Design and interpretation of device preference
trials: marketing tools or scientific instruments? Respiratory Drug
Delivery. 2006;1:19-36.

- (3) Schürmann W, Schmidtmann S, Moroni P, Massey D, Qidan M.
Respimat(R) Soft Mist (TM) Inhaler versus hydrofluoroalkane metered
dose inhaler: patient preference and satisfaction. Treat Respir Med.
2005;4:53-61.

- (4) Hodder R, Reese PR. Asthma patients prefer Respimat(R) Soft
Mist(TM) Inhaler to Turbuhaler(R). Presented at: International
Society for Aerosols in Medicine (ISAM) 16th Congress; June 16-20,
2007; Tours, France.

- (5) Freytag F, Rau-Berger H, Glaab T, Wolf K. Respimat(R) Soft
Mist (TM) Inhaler preferred to Diskus by patients with COPD and/or
asthma. Presented at: 2007 International Conference of the American
Thoracic Society (ATS); May 18-23, 2007; San Francisco, CA.

- (6) Casaburi R, Kukafka D, Cooper CB, et al. Improvement in
exercise tolerance with the combination of tiotropium and pulmonary
rehabilitation in patients with COPD. Chest 2005; 127: 809-817.

- (7) Vincken W, van Noord JA, Greefhorst APM, et al. Improved
health outcomes in patients with COPD during 1 year's treatment with
tiotropium. Eur Respir J 2002; 19: 209-216.

- (8) IMS Health, IMS MIDAS(tm), 2Q2005

- (9) Giraud V et al. Misuse of corticosteroid metered-dose
inhaler is associated with decreased asthma stability. Eur Respir
J.2002;19:246-251

- (10) World Health Organization. World Health Report 2004.
Statistical Annex. Annex table 2 and 3: 120-131.

- (11) Murray CJL, Lopez AD. eds. The Global Burden of Disease: a
comprehensive assessment of mortality and disability from diseases,
injuries, and risk factors in 1990 and projected to 2020. Cambridge;
Harvard University Press; 1996.

- (12) Centers for Disease Control and Prevention. Surveillance
Summaries, August 2, 2002. MMWR: 51 (No SS06).
http://www.cdc.gov/mmwr

- (13) Rudolf M. The reality of drug use in COPD: The European
Perspective. Chest 2000; 117(suppl): 29S-32S.

- (14) van Noord JA, Cornelissen G, Aumann J-L, Platz J, Mueller
A, Fogarty C. Efficacy in COPD patients of tiotropium administered
via the Respimat(R) Soft Mist(TM) Inhaler (SMI) compared to
HandiHaler(R) (HH) Eur. Respir. J 2006; 28 (suppl 50): 431S

- (15) Celli B, ZuWallack R, Wang S, Kesten S. Improvement in
resting inspiratory capacity and hyperinflation with tiotropium in
COPD patients with increased static lung volumes. Chest.
2003;124:1743-1748.

- (16) Casaburi R, Mahler DA, Jones PW, et al. A long-term
evaluation of once-daily inhaled tiotropium in chronic obstructive
pulmonary disease. Eur Respir J. 2002;19:217-224.

- (17) O'Donnell DE, Fluge T, Gerken F, et al. Effects of
tiotropium on lung hyperinflation, dyspnoea and exercise tolerance
in COPD. Eur Respir J.2004 23(6):832-48

- (18) Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes
following treatment for six months with once daily tiotropium
compared with twice daily salmeterol in patients with COPD. Thorax
2003; 58: 399-404.

- (19) Maltais F, Hamilton A, Marciniuk D, et al. Improvements in
symptom-limited exercise performance over 8 h with once-daily
tiotropium in patients with COPD. Chest. 2005;128:1168-1178.

- (20) Pocket Guide to COPD diagnosis, management, and prevention
- A guide for healthcare professionals. Global Initiative for
Chronic Obstructive Lung Disease. Available at:
http://www.goldcopd.com

ots Originaltext: Boehringer Ingelheim and Pfizer
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Boehringer Ingelheim GmbH, Ute E Schmidt, Corporate Division
Communications, 55216 Ingelheim am Rhein, GERMANY, Phone:
+49-6132-77-97296; Pfizer Inc, Francisco Gebauer, Corporate Media
Relations, 235 East 42nd street, New, York, NY, USA, Phone:
+1-212-733-5191


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