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ERS COPD Research Award 2008 sponsored by Boehringer Ingelheim

Mon, 06 Oct 2008 00:00:00 GMT

Berlin and Ingelheim/Germany, 6 October 2008 - The European Respiratory Society (ERS) is pleased to announce that Dr Esther Barreiro, Municipal Institute of Medical Investigation/Hospital del Mar in Barcelona, Spain is this year`s winner of the Society`s annual award for research in the field of Chronic Obstructive Pulmonary Disease (COPD).

The ERS COPD Research Award recognises the work of young European ERS member active in pulmonology research and has been awarded for the eighth time this year. It is sponsored by Boehringer Ingelheim and consists of one sponsorship totalling 50,000 Euros to be used for scientific research projects in the field of COPD.

This year, the prize of 50,000 Euros goes to Esther Barreiro for her study of the specific role of oxidative stress in the respiratory and peripheral muscle dysfunction of COPD patients. Her research of these pathophysiological mechanisms provides the basis for future therapeutic strategies aimed at restoring muscle mass and function. Elucidation of the precise mechanisms will improve the quality of life and survival of COPD patients whereby oxidants modulate muscle proteolysis and apoptosis in the COPD muscle dysfunction appears to be of viral importance given its potential therapeutic implications in these patients.

Dr Barreiro obtained her MD degree at Universitat de Barcelona and became specialized in Respiratory Medicine after finishing the official Spanish residency training period. She began her research career in 1997 at IMIM-Hospital del Mar in Barcelona. She received her Master of Science degree from McGill University, Montreal, Canada, and one year later her PhD degree at Universitat Pompeu Fabra in Barcelona. In October 2001, she joined the IMIM-Hospital del Mar with the aim of investigating the specific roles played by oxidative stress and inflammation in the muscle dysfunction of patients with COPD. In 2004, she also became an Associate Professor of the Experimental Sciences and Health Department at Universitat Pompeu Fabra in Barcelona.

�The ERS is delighted to receive so many applications at such a high standard this year and wishes to thank all applicants for their contributions. In particular, we congratulate Esther Barreiro for her excellent work and extend our thanks to Boehringer Ingelheim, a leader in the research and treatment of COPD, for making this award possible,� said Leonardo Fabbri, ERS President. �I would also like to take this opportunity to invite members to submit entries for next year�s award.�

European members of the ERS up to age 45 are eligible to apply for the award. The official online application form can be found on the ERS website (see related links). The deadline for applications is 26 February 2009. Selection of the successful candidates will be made by the Scientific Committee of the ERS.

The European Respiratory Society
Founded in 1990, the European Respiratory Society (ERS) is a not-for-profit, international medical organisation with almost 9,000 members � scientists, doctors and allied health professionals, coming from over 100 countries. The Society�s mission is to alleviate suffering from respiratory disease and to promote lung health through research, knowledge sharing, medical and public education, and working with patient organisations.

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

COPD landmark trial UPLIFT� proves tiotropium sustains lung function improvements over four years and improves survival rate

Sun, 05 Oct 2008 00:00:00 GMT

Berlin/Germany, 5 Oct. 2008 - Results of the UPLIFT^� trial, presented today at the European Respiratory Society (ERS) Annual Congress, demonstrated that tiotropium (Spiriva^�) administered to Chronic Obstructive Pulmonary Disease (COPD) patients, showed sustained improvements in lung function for up to 4 years (p<0.001), although it did not alter the rate of decline in lung function. The landmark study also reaffirmed the favourable safety profile of tiotropium.

¹ UPLIFT ^�also demonstrated that tiotropium produced a significant delay in time to first exacerbation by a median of 4.1 months (p<0.001), a significant reduction in the number of exacerbations per patient year (14%; p<0.001). In addition, it significantly reduced the risk of exacerbations leading to hospitalisations (Hazard Ratio 0.86; p<0.002) versus the control group. Exacerbations can worsen the clinical course of the disease, so a treatment that significantly reduces exacerbations can positively impact the clinical course of COPD.²

UPLIFT^�, one of the largest COPD trials ever undertaken, involved 5,993 COPD patients from 37 countries around the globe. UPLIFT^� is a landmark COPD trial comparing tiotropium 18 �g once daily with placebo, and allowed all patients to continue with their normally prescribed respiratory medications, including dose adjustments throughout the trial, except inhaled anticholinergics.
Tiotropium also provided statistically significant improvements in health-related quality of life, as measured by the St. George�s Respiratory Questionnaire (SGRQ, p<0.001).^*

Throughout the four-year trial period, patients in the tiotropium group consistently reported a better quality of life than at study initiation.

Further, a statistically significant 16% decrease in the risk of death (p=0.016) was observed in the tiotropium group, while patients received treatment. Within the four year treatment period of the trial, the effect on survival was sustained, even when deaths occurring after early discontinuation of study medication were included in the analysis (p=0.034). Risk of mortality was assessed for the 30 days following the conclusion of the treatment period, and the study revealed an 11% reduced risk of death, although it did not meet statistical significance (p=0.086).

Importantly, tiotropium reduced respiratory (p<0.05) and cardiac morbidity (p<0.05), which reaffirms the favourable safety profile of tiotropium. As in previous studies the most commonly observed side effect was dry mouth.

Professor Marc Decramer, lead investigator and Professor of Medicine at the Catholic University Hospital in Leuven, Belgium said: �UPLIFT^� faced a considerable challenge to demonstrate treatment benefits � unlike most other respiratory trials; it allowed all patients to be treated with all other concomitant respiratory medications, except for inhaled anticholinergics. In UPLIFT^�, tiotropium performed very well over the long term by improving survival rates, lung function, exacerbation rates, and patients� quality of life, while also confirming its favourable safety profile. The UPLIFT^� data adds to the growing knowledge of how treatment can impact the clinical course of COPD. This will allow physicians to prescribe a long-term maintenance treatment early on with confidence.�

The data also demonstrate that tiotropium provides important benefits in moderate disease severity patients (GOLD-Global Initiative for Chronic Obstructive Lung Disease� Stage II).¹ Forty-six percent of the patients in the UPLIFT^� trial were GOLD Stage II. This is one of the largest COPD Stage II patient populations ever studied over four years. The results obtained for this patient group are especially relevant as this is the stage when patients normally first seek treatment for COPD symptoms.

�The results from UPLIFT^� are good news, especially for primary care physicians who are usually the first medical contact a patient has once they decide to seek treatment. UPLIFT� provides the confidence that treatment benefits of tiotropium are sustained long-term, and COPD patients can lead more active lives for longer,� said Dr. Anders �strem, MD, Specialist in Family Medicine, Oslo, Norway and past President of International Primary Care Respiratory Group.

UPLIFT^� proves tiotropium sustains positive effects for patients with COPD. �Patients report feeling better and the benefit seen in survival rates offers more hope to patients, their families, and their physicians,� commented Dr Andreas Barner, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim, responsible for Research, Development and Medicine. �Most importantly, the four-year study highlights the favourable safety profile of tiotropium. Almost 6,000 patients were followed for up to four years, adding to the more than 10 million patient years of market experience for Spiriva^�.�

Notes to Editors

About COPD
COPD is a progressive yet treatable disease that restricts patients� lives over time and is a major cause of death and disability throughout the world. Symptoms include cough, sputum (mucus or phlegm) production, and breathlessness on exertion. Worsening of these symptoms often occurs and can restrict a patient�s ability to perform normal daily activities.¹ The latest World Health Organization (WHO) figures estimate that 210 million people are currently living with COPD and more than 3 million people died from the disease in 2005² - more than breast cancer and diabetes combined.³ Dyspnoea (breathlessness), the main symptom of COPD, is characteristically persistent and progressive and has a serious impact on patients� quality of life.¹ At its most severe, it even limits a patient from simple tasks such as washing and dressing.

UPLIFT^� Study Design
The four-year study was a multicentre (470 sites), multinational (37 countries), randomised, double-blind, placebo-controlled, parallel-group trial which commenced in December 2002. The study included 5993 male and female COPD patients. Patients were randomised 1:1 to receive either 18 μg tiotropium or placebo once daily. In both arms, patients were allowed to take all other respiratory medications usually prescribed for the treatment of COPD, except for inhaled anticholinergics.

About tiotropium (Spiriva^�)
Tiotropium, a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Tiotropium positively impacts the clinical course of COPD, helping to change the way patients live with their disease.^4,5 It is the most prescribed medication for the treatment of COPD in the world.

Tiotropium works through targeting of a dominant reversible mechanism of COPD � cholinergic bronchoconstriction. Tiotropium helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours.

Tiotropium has demonstrated significant and sustained bronchodilation (opening of the airways)⁶ and reduction in hyperinflation (air trapping).^7,8 Tiotropium also demonstrated superior and sustained improvements in lung function (FEV₁) over ipratropium bromide (Atrovent^�) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year⁵ and has also demonstrated superior improvement in key lung function parameters over salmeterol.⁹ In addition, in placebo-controlled studies, patients treated with tiotropium had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.⁶ In clinical trials, the most common adverse reaction reported with tiotropium was dry mouth, which was usually mild and often resolved spontaneously during treatment.⁶ Long-acting bronchodilators, including tiotropium, are a preferred maintenance therapy for COPD from stage II onwards according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines.¹

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion Euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

About Pfizer Inc
Founded in 1849, Pfizer is the world`s largest research-based pharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide

^*Health-related quality of life was evaluated using the Saint George�s Respiratory Questionnaire (SGRQ), where a four-point decrease in SGRQ score is considered to be a clinically meaningful improvement in a patient�s health-related quality of life. Webcast and additional media materials.

Boehringer Ingelheim signs a license agreement with Evec Inc. for its fully-human antibody programme

Thu, 02 Oct 2008 00:00:00 GMT

Ingelheim/Germany and Sapporo/Japan, 2 October 2008 � Boehringer Ingelheim has signed a licence agreement with Evec, Inc., Japan, for one of its fully-human therapeutic antibody programmes. Based on the agreement, Boehringer Ingelheim will obtain worldwide exclusive development and commercialisation rights for the complete programme. In return, Evec expects to receive an upfront payment and milestone payments depending on development phases from Boehringer Ingelheim totalling up to EUR 55 million, as well as royalty payments associated with potential product sales. Further financial details have not been disclosed.

Prof. Kenzo Takada, Chairman of Evec said �We are excited to enter into this collaboration with Boehringer Ingelheim, a world recognised player in the biotechnology arena. This agreement marks a significant milestone in the development of Evec. Evec is one of the first Japanese bio venture companies which has concluded a license agreement with a western multinational pharmaceutical company. We believe that this will encourage furthermore the research and development of Japanese bio venture companies�.

Dr. Andreas Barner, Vice-Chairman of the Board Corporate Division Pharma Research, Development and Medicine at Boehringer Ingelheim said �We are impressed by Evec�s technology of generating fully-human antibodies and are delighted to be one of the first western multinational pharmaceutical companies to enter into a license agreement with a Japanese bio venture company. As a research-driven pharmaceutical company, Boehringer Ingelheim is committed to discovering and developing products which represent high therapeutic value. This collaboration has the potential to answer the patients� and physicians� need for new treatments that are both safe and efficacious.�

About Evec
Evec is a bio venture company having its head office in Sapporo, Japan, established in 2003, spun off from Hokkaido University. Evec is specialised in development of a wide spectrum of human monoclonal antibodies in multiple therapeutic areas, such as cancer, inflammatory diseases and infectious diseases by an Epstein-Barr Virus Transformation Method.

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Recent research shows significant benefits in acute ischaemic stroke with Actilyse� beyond currently approved three hour treatment window

Thu, 25 Sep 2008 00:00:00 GMT

Ingelheim, Germany, 25 September 2008 � First results from ECASS 3 (European Cooperative Acute Stroke Study) were presented today at the 6th World Stroke Congress in Vienna, Austria, showing that treatment with Actilyse^� (alteplase) between 3 and 4.5 hours after stroke onset can improve clinical outcome. These results were also published today in the New England Journal of Medicine.¹

Importantly, data from the trial show that the safety profile of Actilyse^�, a recombinant tissue plasminogen activator (rt-PA), when used in the 3 to 4.5 hour time window is consistent with the safety profile reported in previous clinical trials that investigated Actilyse^� use in the currently approved time window of 0 to 3 hours, including the incidence of haemorrhagic events.^2,6

ECASS 3, which included 821 patients (418 treated with alteplase vs. 403 placebo-treated patients), was a randomised, double-blind, placebo-controlled trial designed to evaluate whether the efficacy and safety of alteplase were maintained up to 1.5 hours beyond the standard 3-hour time window.

The study showed that patients treated with alteplase in this extended time window had a 34 percent improvement in the odds of having a favourable outcome versus placebo (absolute 7.2% improvement; p=0.04) as measured by the modified Rankin Scale (mRS 0�1). This finding is important as it demonstrates that alteplase can increase the likelihood of achieving only minimal or no disability post-stroke, now shown for the first time beyond 3 hours and up to 4.5 hours.

�Early treatment remains the cornerstone of acute stroke therapy and it is of paramount importance that patients arriving in stroke units who are eligible for thrombolysis should be treated without delay. However, the new ECASS 3 data show that stroke can be effectively managed also in patients who are unable to reach a stroke centre within three hours,� commented Professor Werner Hacke, Department of Neurology, Ruprecht-Karls-University of Heidelberg, Germany, lead study investigator. �The results of the trial show that a large group of patients currently excluded may benefit in the future from this therapy.�

Furthermore, the ECASS 3 data are complemented by similar findings from SITS-ISTR (Safe Implementation of Treatments in Stroke � International Stroke Thrombolysis Registry), an academic-driven acute stroke registry of thrombolysis for ischaemic stroke, which were published last week in The Lancet⁷. These data, collected in a real life clinical setting, suggest that patients who are treated with alteplase in accordance with the current European summary of product characteristics, but in an extended time window of treatment initiation between 3 and 4.5 hours after stroke onset (Actilyse^� is currently approved for use within the 3 hour time window), can experience a similar clinical outcome as compared with patients who are treated earlier.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
- ends -

Notes to Editor
Modified Rankin Scale
The Modified Rankin Scale is a numerical functional assessment scale used to rank levels of disability after stroke. Patients receive a score between 0 and 6, where 0 represents no symptoms at all and higher scores represent increasingly severe disability.⁸

About ECASS 3
ECASS 3 was a randomised, double-blind, multicentre, placebo-controlled trial of Actilyse^� in acute ischaemic stroke where thrombolysis is initiated between 3 and 4.5 hours after stroke onset. The study, sponsored by Boehringer Ingelheim, was requested by European authorities to support the licencing of Actilyse^�. ECASS 3 started in July 2003 and was completed in February 2008. The patients included in the study were in line with the Actilyse^� indication in the European Summary of Product Characteristics⁶ with the exception of the time window. A total of 821 patients were recruited in 15 European countries.

About Actilyse^�
Stroke is a neurological emergency that can affect a specific area, or sometimes all of the brain. It can be caused by a burst blood vessel (haemorrhagic stroke) or occur when a vessel is obstructed by a blood clot (ischaemic stroke. Actilyse^� (active ingredient: alteplase), a recombinant tissue plasminogen activator (rt-PA), is a genetically engineered version of naturally occurring tissue plasminogen activator, which has the biological function of removing small clots that routinely form in the bloodstream. Actilyse^� is the only drug indicated for thrombolytic treatment of acute ischaemic stroke within three hours of symptom onset, and is recommended by international treatment guidelines.^9,10In line with the current Actilyse^� label, patients need to receive the medication within three hours of the onset of their stroke symptoms.⁶ Alteplase was first approved in 1987 in major countries across the globe in the indication acute myocardial infarction, followed by subsequent approvals in the indications pulmonary embolism and acute ischaemic stroke (registered indications can vary across the globe.

Actilyse^� is registered in over 85 countries across the world and marketed outside North America and Japan by Boehringer Ingelheim. Alteplase is marketed under the brand name Activase� in the U.S.A. by Genentech, Inc. and in Canada by Roche Canada, where it has been used extensively for the treatment of acute ischaemic stroke since 1996 and 1999, respectively.

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Positive UK health technology appraisal for novel oral anticoagulant Pradaxa� (dabigatran etexilate)

Wed, 24 Sep 2008 00:00:00 GMT

Ingelheim/Germany, 24 September 2008 � The UK�s National Institute for Health and Clinical Excellence (NICE) has recommended Pradaxa^� (dabigatran etexilate) as an option, within its marketing authorisation, for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery throughout the National Health Service (NHS) of England and Wales.¹

After a single technology appraisal, NICE stated that oral once daily Pradaxa^� was likely to be of equivalent clinical and cost effectiveness to the standard care options for the prevention of venous thromboembolism (VTE) which are generally administered via injection and/or require monitoring.¹ NICE highlighted that oral administration of Pradaxa^�, without the need for monitoring, would reduce administration costs and may support adherence to treatment.1 This NICE recommendation of Pradaxa^� provides widely recognised endorsement for the product�s clinical efficacy, safety and cost effectiveness.

Professor Ajay Kakkar MD, Professor of Surgical Sciences at Barts and the London School of Medicine, commented:

�Venous thromboembolism remains an important clinical challenge. Today�s recommendation by NICE for the novel orally active anticoagulant dabigatran provides an important extension to our armamentarium for preventing potentially fatal blood clots after total hip and knee replacement surgery, further facilitating best practice in terms of out of hospital prevention.�

This positive assessment marks a key milestone for Pradaxa^�. Rapid progress has already been made as Health Technology Appraisal bodies in Scotland (Scottish Medicines Consortium), Denmark (Danish Medicines Agency), the Netherlands (The Health Care Insurance Board) and Greece have favourably appraised Pradaxa^��s clinical and cost effectiveness. The regulatory approval of Pradaxa^� by the European Medicines Agency (EMEA) was obtained in March 2008^2,3 and marketing authorisations were also received from Canada, Brazil, New Zealand and Argentina amongst others. To date, Pradaxa^� has been launched across a total of eleven countries.

It is estimated that 543,454 deaths in Europe per year are VTE-related, more than double the number from breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined.⁴ In the UK alone, VTE is estimated to cost 640 million GBP (950 million euros) every year to manage, yet 60 to 80 per cent of these costs could be saved through preventative measures including anticoagulation.^4,5

The charity AntiCoagulation Europe welcomed NICE�s recommendation. Chief Executive, Eve Knight, said:

�We are delighted with today�s NICE announcement. It is appalling that patients are still developing and dying from VTE, which could very often be prevented by risk assessing every patient on admission to hospital and giving preventative treatment where needed. Pradaxa, a once daily oral therapy for use in post orthopaedic surgery, will enable clinicians and patients to make decisions on choice of treatment appropriate to their clinical needs.�

Data from the phase III RE-NOVATETM and RE-MODELTM studies showed oral, once daily administration of both 150 and 220 mg Pradaxa^� was as effective and safe as injectable enoxaparin (40 mg) in preventing VTE and all cause mortality following total hip and total knee replacement surgery.^6,7

Dr Andreas Barner, Vice Chairman of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said:

�Today�s announcement from NICE represents an important milestone for Pradaxa. We are pleased that since the EMEA approval in March Pradaxa has progressed smoothly through key EU Health Technology Appraisals. Our ongoing extensive RE-VOLUTIONTM clinical trial programme is investigating Pradaxa across several further therapeutic areas.�

Pradaxa^� is an oral direct thrombin inhibitor with a rapid onset and offset of action and a predictable anticoagulation effect without the need for coagulation monitoring.^8,9 It prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme in the coagulation cascade that enables conversion of fibrinogen into fibrin.^9-1 In contrast to warfarin, Pradaxa^� exhibits no drug-food interactions and has a low potential for drug-drug interactions.^10,12

Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa^� within the global RE-VOLUTION� clinical trial programme which involves over 38,000 patients. Pradaxa^��s efficacy and safety is being assessed for:

Stroke prevention in atrial fibrillation (SPAF) in the RE-LY� trial � the largest SPAF trial to date
- Enrollment of a total of 18,113 patients for the RE-LY� trial was completed in December 2007
- Results are expected in 2009
Treatment of acute VTE - results expected in 2009
Secondary prevention of VTE
Prevention of cardiac events in patients with acute coronary syndrome

Notes to Editors
Wording of Today�s NICE announcement
Dabigatran etexilate, within its marketing authorisation, is recommended as an option for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip replacement surgery or elective total knee replacement surgery.

The Committee acknowledged that oral administration of dabigatran etexilate, without the need for monitoring, would reduce administration costs and may support adherence to treatment. The Committee therefore concluded that dabigatran etexilate should be recommended as an option in the circumstances in which LMWH (or fondaparinux as an alternative) may be offered.

Recommended Dosing of Pradaxa^� for VTE Prevention
The standard recommended dosage of Pradaxa^� in VTE prevention is a fixed oral dose of 220 mg given once daily.¹² A single capsule of 110 mg (half-dose) is administered orally between 1 and 4 hours following surgery, continuing with 2 capsules once daily thereafter for a total of 10 days in total knee replacement patients and 28-35 days in total hip replacement patients.¹² A second approved dosage of 150 mg taken as two capsules of 75 mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.¹²

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Landmark UPLIFT� study reaffirms the safety of Spiriva� (tiotropium) in patients with Chronic Obstructive Pulmonary Disease

Wed, 24 Sep 2008 00:00:00 GMT

For further information please see the news release issued today by Prof. Marc Decramer, Katholieke Universiteit Leuven, Belgium.

Established safety profile of Spiriva� confirmed by 30 rigorously controlled clinical trials

Tue, 23 Sep 2008 00:00:00 GMT

Ingelheim/Germany, 23 September 2008 - Boehringer Ingelheim and Pfizer have released a new analysis of 30 rigorously controlled clinical trials confirming the long term safety profile of Spiriva^� (tiotropium). The new and expanded safety data contradicts the conclusions about tiotropium in an article by Singh et al. published in the 24 September issue of the Journal of the American Medical Association.¹ Both companies considered it important to release these data to ensure doctors have the most comprehensive, up-to-date safety information on tiotropium in order to make the best treatment decisions for their patients.

Because COPD patients (Chronic Obstructive Pulmonary Disease) have in general a higher cardiovascular risk than the average population,² cardiovascular safety in a COPD medication is of critical importance. Therefore Boehringer Ingelheim has put special emphasis on the broad investigation of Spiriva^� including its cardiovascular safety.

The latest analysis of 30 placebo-controlled double-blind, randomized trials with data from 19,545 COPD patients (tiotropium 10,846; placebo 8,699), conducted by Boehringer Ingelheim demonstrated that there is no increased risk of death (all-cause) or death due to cardiovascular events in patients treated with Spiriva specifically:

No increased risk of total (all-cause) mortality (relative risk ratio for all cause mortality= 0.88, CI=95% 0.77, 0.999)
No increased risk of mortality due to cardiac (relative risk ratio for mortality due to cardiac events= 0.77, CI= 95% 0.58, 1.03) and vascular events (relative risk ratio for mortality due to vascular events= 0.44, CI= 95% 0.19, 1.02).
No increased risk in stroke (relative risk ratio for stroke = 1.03, CI= 95% = 0.79, 1.35), and
No increased risk for myocardial infarction (relative risk ratio for myocardial infarction 0.78, CI= 95% 0.59, 1.02) associated with tiotropium.

�We strongly disagree with the conclusion reached by Singh et al. We have disclosed to regulatory authorities worldwide this important information which is part of a very robust analysis of all our double-blind, placebo-controlled, parallel group trials with a duration of at least four weeks. Our analysis, which includes data from the four-year UPLIFT^� trial, supports the safety profile of Spiriva^�,� commented Dr Andreas Barner, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim, responsible for Research, Development and Medicine. �Patients and physicians can be confident that Spiriva^� is a safe and effective medication. In clinical trials and since its introduction, we have collected extensive safety data adding up to an exposure of more than 10 million patient years.�

Peer-reviewed meta-analyses of aggregate published data like Singh et al1 have their appropriate place in scientific research. However, these analyses have well-recognised limitations, such as combining study summaries rather than analyzing individual patient data, or not correcting for patients who dropped out of trials early.

Most of the evidence in the analysis by Dr. Singh and colleagues is contributed by a single study, the Lung Health Study,⁴ involving a different anticholinergic medication, (ipratropium). In this study most of the cardiovascular deaths occurred among patients who were not using their medication. Other limitations include the inability to adjust for treatment duration and accounting for patients who discontinue the trial early, apparent double-counting of trials and combining placebo and active comparator drugs in the control group.

The integrated safety data presented today includes data from the UPLIFT trial, a study that includes mortality as a pre-specified endpoint. UPLIFT� (Understanding Potential Long-term Impacts on Function with Tiotropium), one of the largest COPD trials ever undertaken, involved 5,993 COPD patients from 37 countries around the globe over a four-year treatment period. Patient safety during the trial was closely followed by an independent Data Safety Monitoring Board.

The complete results of the UPLIFT^� trial will be presented on October 5th during the European Respiratory Society 2008 Annual Congress in Berlin.

About Spiriva^� (tiotropium)
Spiriva^�, 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^� positively impacts the clinical course of COPD, helping to change the way patients live with their disease.^5,6 It is the most prescribed medication for the treatment of COPD in the world.⁷

Spiriva^� works through targeting of a dominant reversible mechanism of COPD - cholinergic bronchoconstriction. Spiriva^� helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours.

The Spiriva^� clinical trials programme has recruited over 20,000 patients.⁸ Spiriva^� has demonstrated significant and sustained bronchodilation (opening of the airways)^6,9 and reduction in hyperinflation (air trapping).^10,11 Spiriva^� also demonstrated superior and sustained improvements in lung function (FEV1) over ipratropium bromide (ATROVENT^�) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year⁶ and has also demonstrated superior improvement in key lung function parameters over salmeterol.¹² In addition, in placebo-controlled studies, patients treated with Spiriva^� had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and fewer exacerbations leading to hospitalizations.⁹ In clinical trials, the most common adverse reaction reported with Spiriva^� was dry mouth, which was usually mild and often resolved during treatment.^6,9

Long-acting bronchodilators, including Spiriva^�, are a preferred maintenance therapy for COPD from stage II onwards according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines.¹³

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

About Pfizer Inc
Founded in 1849, Pfizer is the world`s largest research-based pharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Landmark research heralds new era in dog heart treatment and longer life for dogs

Thu, 04 Sep 2008 00:00:00 GMT

Ingelheim/Germany, 4 September 2008 - Veterinarians and dog owners are today welcoming new research that delivers the promise of an extended happy life together for millions of dog owners and their pets. The three-year study demonstrates that dogs suffering from the most common type of heart failure live on average 91% (267 days vs. 140 days) longer when treated with the product Vetmedin^� (pimobendan) compared with another common treatment option.¹

Results from the QUEST (Quality of Life and Extension of Survival Time) study, published in the current issue of the Journal of Veterinary Internal Medicine, mark a significant milestone in canine cardiac health. Experts report that 25% of all small to medium-sized dogs over the age of seven are likely to suffer from heart disease at some point in their life,² and 75% of those cases are caused by myxomatous mitral valve disease (MMVD),³ sometimes known as �valvular insufficiency� or �endocardiosis�.

Adrian Boswood from the Royal Veterinary College, London, a Veterinary Cardiology Specialist and a lead-investigator on the study, explains that the independent QUEST trial set out to explore the impact on survival of Vetmedin^� versus another current treatment, benazepril hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor.

�With QUEST demonstrating that dogs treated with Vetmedin^� live on average nearly twice as long as those on benazepril,¹ it is now time for us as veterinary cardiologists and practising veterinarians to look again at how we are treating our patients suffering from this serious condition.�

Dr. Michael O�Grady from the Ontario Veterinary College, University of Guelph, a fellow lead-investigator added, �The QUEST study provides compelling evidence that dogs with the most common form of heart failure should be receiving Vetmedin^� as an essential part of their treatment regimen.�

QUEST is the largest international study ever conducted looking at treatment for congestive heart failure (CHF) caused by MMVD, with 260 dogs studied in 11 countries, across three continents, over a period of three years.

The study was conducted by a team of 32 independent veterinary cardiologists from Australia, Canada, France, Germany and the United Kingdom among other countries.

CHF caused by MMVD most commonly affects older, small breed dogs, including Cavalier King Charles Spaniels, Poodles, Chihuahuas and Dachshunds.3

Symptoms of this form of heart failure that dog owners should look for include coughing, reduced tolerance for exercise, anxiety and restlessness during the night, and laboured breathing.³ If these symptoms are present, it is important that dog owners take their pets to their veterinarians for assessment and treatment.

�Dog owners should be encouraged by the results of the QUEST study, as it demonstrates an important treatment option for lengthening a dog�s life when it has this common, debilitating and life-threatening heart condition,� said Jens H�ggstr�m, Professor of Veterinary Internal Medicine, University of Uppsala and the other lead-investigator on the trial.

Owners now have new information regarding the best chance for enjoying the maximum time possible with their dogs suffering from the most common cause of heart failure.

�With our dogs being so important to our families, we owners should do all we can to make sure our pets are receiving the most effective treatment�, said Sally Copland, owner of Fern, an eight-year-old King Charles Spaniel being treated with Vetmedin^�. �None of us want our pets� lives unnecessarily cut short,� she added.

The full QUEST study results, providing hard evidence about the importance of using Vetmedin, appear in the September/October 2008 issue of the Journal of Veterinary Internal Medicine.

Boehringer Ingelheim
Boehringer Ingelheim Animal Health and Boehringer Ingelheim Vetmedica belong to 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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of almost 11 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

The animal health business is conducted in more than 20 countries including USA, Canada, France, Germany, UK, Italy, Spain, Mexico, the Nordic countries Japan and China. Since 1955, Boehringer Ingelheim Animal Health is contributing to an adequate supply of safe, nutritious food and is promoting the emotional and physical benefits arising from the human-animal bond.

Veterinary cardiology experts in the following countries are available for comment. For country-specific information please contact

Australia/ New Zealand	Angela Hinchley Spinifex Communications	+61 (02) 9954 4051 angela.hinchley@spinifexcommunications.com.au
Canada	Cristiane Doherty Delta Media Inc.	+1 (613) 233 9191 Cristiane@DeltaMedia.ca
France	Dominique Kerforn i&e Consultants	+33 (0) 1 56 03 12 75 dkerforn@i-e.fr
Germany	Veterinary press: Deiter Wense Presseb�ro Vennebusch	+49 (0) 53 61 88 83 00 vdwense@inpunctodesign.de
	Consumer press: Petra von der Lage MasterMedia	+49 (0) 40 50 71 13 44 vonderlage@mastermedia.de
UK	Danny Stepto Red Door Communications	+44 (0) 20 8392 8040 dstepto@rdcomms.com
USA	Illinois Blasdel Blasdel Cleaver Schwalbe Communications, LLC	+1 (816) 474 3166 Illinois@bcsthinktank.com

First landmark ARB trial against placebo shows Micardis� (telmisartan) reduces the risk of cardiovascular death, heart attack and stroke in ACE-intolerant high-risk patients1

Sun, 31 Aug 2008 00:00:00 GMT

Munich, Germany, 31st August, 2008 - The results of the TRANSCEND^� trial demonstrate that Micardis^� 80mg (telmisartan) reduces the risk of cardiovascular death, myocardial infarction/heart attack and stroke in high-risk cardiovascular patients by 13% compared with those patients already receiving best standard of care (p=0.048), referring to the same endpoint as that defined as the primary endpoint of the landmark HOPE trial published in 2000.^1,2 Therapy with telmisartan was well tolerated and showed a trend towards a lower rate of discontinuation.¹

The new data on 5,926 patients from 40 countries were presented today at the annual meeting of the European Society of Cardiology (ESC) in Munich, Germany. TRANSCEND^� (Telmisartan Randomised AssessmeNt Study in ACE-iNtolerant subjects with cardiovascular Disease) is the first landmark trial to test and prove the cardiovascular protective effects of an angiotensin II receptor blocker (ARB) - Boehringer Ingelheim�s telmisartan - versus placebo, on top of standard therapy (including anti-hypertensives, anti-platelet therapy and statins), in high-risk individuals who cannot tolerate an angiotensin converting enzyme (ACE)-inhibitor.

An 8% reduction of events in the pre-specified primary endpoint made up of the composite of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure was seen in the trial, which was statistically non-significant with a p-value of 0.216 (HR 0.92).¹ Translated into absolute figures, only 465 patients in the telmisartan arm experienced a cardiovascular event versus 504 patients receiving placebo on top of current best standard of care.

All cardiovascular hospitalisations were significantly reduced with telmisartan (894 vs 980; p=0.025). In general, the data show that the protective effects of telmisartan were more pronounced the longer patients were on treatment.¹

�Earlier this year, the ONTARGET^� Trial showed that telmisartan is as protective as, but better tolerated than the ACE-inhibitor ramipril. The TRANSCEND^� results represent a moderate but important step forward for high-risk patients who cannot tolerate an ACE-inhibitor,� commented Professor Salim Yusuf, lead investigator of the ONTARGET� Trial Programme and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada.

Commenting on the implications of the results for general practitioners, Dr Sarah Jarvis, Richford Gate Medical Practice, London, said �Until now, physicians treating ACEI-intolerant patients at risk of heart attack or stroke did not have a proven alternative to the ACE-inhibitor ramipril � a situation we faced with one in five high risk patients. We now have the scientific evidence to show that telmisartan protects patients ACEI-intolerant patients against heart attack, stroke and cardiovascular death while showing a placebo-like tolerability. This builds on previous findings of the ONTARGET ^� trial and gives physicians the confidence of prescribing a drug with proven efficacy that will be taken as prescribed and not left in the drawer.�

TRANSCEND^� included a broad cross-section of cardiovascular high risk patients (patients older than 55 years, who have had myocardial infarction, peripheral arterial occlusive disease, stroke or transient ischaemic attacks or suffer from diabetes mellitus and additional risk factors).

The trial, a parallel study to the ONTARGET^� trial³, which together form the ONTARGET^� Trial Programme, investigated the effects of telmisartan 80mg in 5,926 patients intolerant to widely-prescribed ACE-inhibitors. Worldwide, 10-39% of patients with hypertension are intolerant to ACE-inhibitors^4-6which often leads to discontinuation of treatment leaving patients unprotected. Side effects associated with ACE-inhibitors include intolerable cough and rare, but potentially life threatening, angioedema.^4-6

Also of note, the risk reduction of 13% with telmisartan was achieved despite a high proportion of patients receiving proven therapies such as statins, antiplatelet agents or betablockers.

�While cardiovascular treatment has improved substantially over the last ten years, telmisartan still further reduced cardiovascular risk. We are proud to have advanced medical knowledge in the cardiovascular arena with our landmark studies ONTARGET^� and the parallel trial TRANSCEND^�. We have followed almost 50,000 telmisartan patients in clinical trials in the last 5 years, and now have experience from daily use of telmisartan summing up to 25 million patient years all over the world. This makes the medication one of the best-researched cardiovascular drugs with an outstanding efficacy and safety/tolerability profile, � commented Dr Andreas Barner, vice-chairman of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine.

Cardiovascular disease (CVD) is the leading cause of death worldwide, causing over 17.5 million deaths per year.⁷ 7.6 million people die from a heart attack and 5.7 million die from a stroke every year.⁷ Global deaths from CVD are predicted to reach approximately 25 million by 2020.⁸ CVD is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.⁸ A major stroke is viewed by more than half of those at risk as being worse than death.⁹

~ENDS~

Notes to editors

About telmisartan (Micardis^�/Kinzal^�/Pritor^�)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and is being investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET^�, PROTECTION^� and PRoFESS^� over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan (for more information please visit
www.news-landmarktrials.com ).

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis^� and MicardisPlus^� (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis^�, Bayer HealthCare promotes telmisartan under the brand names Kinzalmono^�, Kinzalkomb^� (combination with hydrochlorothiazide), and Pritor^� and PritorPlus^� (combination with hydrochlorothiazide) in markets across Europe. Pritor^�, and PritorPlus^� is also marketed by GlaxoSmithKline in selected markets.
The sponsor of the ONTARGET^� Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer HealthCare and GlaxoSmithKline.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world�s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Pramipexole clinical trial programme in Restless Legs Syndrome (RLS) reveals new significant results

Tue, 26 Aug 2008 00:00:00 GMT

Ingelheim, Germany, 26 August 2008 � Results from a large pramipexole trial programme in Restless Legs Syndrome (RLS) conducted by Boehringer Ingelheim were presented at the 12th European Federation of Neurological Societies (EFNS) Annual Congress held in Madrid, Spain, from 23 to 26 August. The results of two large Phase IV trials showed that while pramipexole significantly improves the characteristic symptoms of RLS among patients with moderate to severe RLS, it also demonstrated significant beneficial effects on associated symptoms such as limb pain and health-related quality of life, including associated mood disturbance.^1,2 Limb pain and mood disturbance are important secondary ailments commonly experienced by RLS patients,^3-5 and these studies are the first in which an approved RLS treatment has demonstrated benefits addressing these symptoms in a clinical study in RLS patients.

Study details:
Two combined phase IV double-blind, randomised, 12-week trials assessing the impact of pramipexole on associated pain showed significant improvement in RLS overall and in RLS-associated limb pain in the pramipexole treatment arms (n=381; 0.125-0.75 mg/day) compared with placebo (n=378). (Patients rated pain with a visual analogue scale (VAS) before and after treatment).¹

At endpoint, scores on the International RLS Study Group Rating Scale (IRLS) decreased more (i.e. symptoms were reduced) in patients treated with pramipexole than with placebo (adjusted mean of �14.2 vs �8.1, p<0.0001 and �13.4 vs �9.6, p=0.0001 in the respective trials).
Reduction in limb pain was also greater with pramipexole than placebo with a median change of −31.0 vs −11.0 (p<0.0001) and −33.5 vs −11.0 (p<0.0001) in the respective trials.

In a further study assessing the effect of pramipexole on RLS related quality of life (QoL) in RLS patients with mood disturbance², pramipexole (n=203) demonstrated an overall significant improvement in QoL and associated mood disturbance at four and 12 weeks compared with placebo (n=199).

Improvements in daily activities, physical functioning and vitality are correlated with reductions in RLS symptoms: median changes for pramipexole versus placebo were +17.5 and +10.0 (four weeks, p<0.0001) and +20.0 vs +10.0 (12 weeks, p<0.0001).²
Adjusted mean changes in IRLS total scores, evaluating the effect of treatment on the characteristic RLS symptoms, also improved with pramipexole over placebo: -14.0 vs -8.2 (4 weeks, p<.0001) and �14.2 vs �8.1 (12 weeks; p<0.0001).
A significant correlation was observed in changes in RLS-QoL and IRLS scores (12 weeks, p<0.0001).²

�Many studies have noted the fact that RLS has a far-reaching symptom spectrum that can severely impact and limit several aspects of everyday life. The pramipexole clinical trials reinforce the need for a simple, effective treatment for people with RLS to address these symptoms, including limb pain and associated mood disorder, in addition to the characteristic RLS symptoms. These important new findings reaffirm pramipexole as an effective pharmacological regimen for the treatment of RLS. The studies have proven that pramipexole can offer patient-specific benefits, which combined, can lead to significant improvement of patients� overall quality of life�, commented Magdolna Hornyak, MD, Assistant Professor, Interdisciplinary Pain Centre, University Hospital, Freiburg, Germany.

The impact of RLS is far-reaching and goes beyond the uncontrollable urge to move one�s legs or the inability to sleep, and, therefore, effective treatments need to address the range of symptoms that limit daily activity experienced by patients. These new data add to the evidence for pramipexole as a simple, effective therapy for patients with moderate to severe RLS.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Notes to Editor
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years⁶ and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.⁵ The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.

About pramipexole
Pramipexole (known under the trade names Mirapexin^�, Sifrol^�, Mirapex^� and Pexola^�) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. Pramipexole was approved in 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is currently marketed in over 70 countries across the globe.

The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, fatigue and dizziness. The most commonly reported adverse reactions in early and late Parkinson�s disease in clinical trials were dizziness, nausea, dyskinesia, hypotension, somnolence, insomnia, hallucination, constipation, headache and fatigue.

Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.

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 135 affiliates in 47 countries and 39,800 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 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.