Boehringer Ingelheim RSS-Newsfeed

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

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 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.

Boehringer Ingelheim to sign cooperation with HISOAR in China

Mon, 25 Aug 2008 00:00:00 GMT

Taizhou/China and Ingelheim/Germany, 28 August 2008 - Boehringer Ingelheim and Hisoar, a Chinese pharmaceutical production company based in Taizhou, today jointly announced a strategic production alliance in China. Within the the framework of this production alliance Boehringer Ingelheim complements its worldwide chemical production network with strong partners for the manufacturing of chemical intermediates for its active pharmaceutical ingredients (APIs). These chemicals will then be processed further in Boehringer Ingelheim�s plants in Germany, Italy, Spain and the United States.

From September 2008 onwards, Boehringer Ingelheim will supply know-how as well as technical support for production to Hisoar. Hisoar in turn will invest into new specific production facilities for Boehringer Ingelheim at its new site in Chuannan. The production for Boehringer Ingelheim in Chuannan is planned to start in early 2009.

Mr. Bangpeng Luo, the Chairman of Hisoar commented: We are very pleased to have the opportunity to cooperate with Boehringer Ingelheim, a large multinational pharmaceutical company. This cooperation, both from the technical and the management level, will raise Hisoar�s market positioning and standing and it will create an unusual benefit for Hisoar to enter the international levelof raw material suppliers, and indicates that Hisoar has come a big step forward towards internationalization.�

Dr Hans-J�rgen Leuchs, Member of the Board of Managing Directors and responsible for the Corporate Board Division Operations of Boehringer Ingelheim added, �Boehringer Ingelheim is looking forward to a fruitful cooperation with our Chinese partner to have in future more flexibility, short production timelines and an appropriate capacity for the continuously growing demand for Boehringer Ingelheim�s medications across the globe.�

About Hisoar
Established in 1966, Hisoar is a listed company in shenzhen stock exchange market that specializes in the production, sales and distribution of chemical intermediates and active pharmaceutical ingredients to the pharmaceutical industry. It is located in Taizhou of Zhejiang province, one of the areas with the most economic vitality in China. Hisoar is an enterprise which specializes in researching , developing and sales of API, medicine( including high-level intermediate), animal drug and other product in chemical area. In 2007 the sale is RMB 1,035,000,000. Hisoar has Waisha ,Chuannan ,and Quanfeng 3 production bases, the facilities satisfy with the requirement of the pharmaceutical chemistry. Hisoar establishes the GMP and EHS system according the international standard, and several product have passed the COS authentication FDA authentication , PMDA authentication of Europe, America , Japan and other main drug administration market. Hisoar has a certain impact on the area of drug in the international system.

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 the Corporate Headquarters of Boehringer Ingelheim 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.

Role of pramipexole in key research areas of Parkinson�s disease management discussed at 12th EFNS Congress

Mon, 25 Aug 2008 00:00:00 GMT

Madrid, Spain, 25 August 2008 � Data presented during the 12th Congress of the European Federation of Neurological Sciences (EFNS), held in Madrid, Spain, from 23 to 26 August, highlight important new ongoing studies with pramipexole in a number of key research areas in Parkinson�s disease (PD): clinical benefits of early treatment initiation, management of PD-related depressive symptoms and a new formulation currently under investigation.

Professor Anthony Schapira, Chairman of the University Department of Clinical Neurosciences, Institute of Neurology, Queen Square, UCL, and Professor of Neurology at the National Hospital and Royal Free Hospital, London, UK and lead study investigator for PROUD^*,1, presented a new approach to investigate the slowing of clinical progression in PD, a key focus of current research due to this important unmet need. Previous pramipexole studies have suggested a potential neuroprotective effect, such as the CALM-PD^** study^2,3 and in vitro studies. PROUD, however, is the first study to combine measurements of clinical outcomes in a PD patient with measurements of dopamine transporter density of certain brain areas (basal ganglia), through a SPECT imaging arm of the study.¹

Commenting on the study so far, Professor Schapira said: �The debate on when and how to treat early Parkinson�s disease patients has been ongoing. Currently, treatment would typically be initiated when symptoms have caused disability. However, providing the medical evidence for a treatment to retard or prevent the progression of PD is a major therapeutic priority and the PROUD study aims to shed more light into this question. Pramipexole was considered an optimal candidate for this study due to evidence suggesting possible benefits to PD patients beyond treating the well-known core symptoms. Based on the unique technique used in this study, PROUD may provide a major breakthrough in our understanding of early PD treatment which would offer hope to the ever increasing number of patients diagnosed with Parkinson�s disease.�

Study results are expected to be available in 2009.

Pramipexole studies pursuing other new avenues of research to meet treatment needs
Further areas of current PD research with pramipexole are the management of PD-related depressive symptoms and ongoing studies to evaluate a new formulation so as to provide physicians and patients using pramipexole with an even broader treatment regimen to better meet differing patient needs and lifestyles.^4,5,6

PD-related depressive symptoms
A new pramipexole study conducted in approximately 70 European centres aims to assess management of depressive symptoms in PD patients.⁷ Emerging data suggest that pramipexole may have a positive effect on depressive symptoms and motivation associated with PD, in addition to effectively controlling the motor symptoms of PD.^8-16 The specific receptor profile of pramipexole may be responsible for the possible antidepressant properties of this compound and clinical research is ongoing to determine this aspect of pramipexole�s pharmacological profile in more detail.^17,18,19

Professor Paolo Barone, Department of Neurological Sciences, University of Napoli-Federico II, Naples, Italy and lead investigator of both PRODEST⁴ and the new European study⁷ said: �Previously, the PRODEST study identified that PD-related depressive symptoms are common, with nearly half of those PD patients receiving anti-depressants continuing to experience depressive symptoms. These symptoms impact significantly on quality of life, both for PD patients and their carers. The new European study aims to provide answers on the role pramipexole may play in managing these commonly experienced PD-related depressive symptoms that are often under-recognised and consequently under-treated.�

Widening choice of pramipexole treatment options
Favourable results of pharmacokinetic phase I studies with a new once daily pramipexole extended release formulation were presented at EFNS and support the development of this new formulation.^5,6 Pramipexole is the leading dopamine agonist treatment for PD and these ongoing studies aim to add to the existing treatment regimen with a once daily formulation to go one step further to meeting a broader range of patients� needs.

Please be advised
This release is provided by 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 information is not intended for distribution within the U.S.A.

Notes to Editor:
About Parkinson�s disease (PD)
PD is the second most common chronic neurological disorder in older adults after Alzheimer`s. Its worldwide prevalence is estimated to be approximately one to two percent of those over 65 years.^20,21 Although traditionally PD is associated with motor symptoms (such as tremor, rigidity, slowed motion, imbalance, shuffling gait, loss of facial expression), the non-motor symptoms, including depressive symptoms, pain, cognitive impairment and sleep disorders can be significant. The symptoms can vary from patient to patient, but worsen over time.

About PROUD¹ (^*Assessment of Potential ImPact of PRamipexole On Underlying Disease)
The PROUD study was designed to test the hypothesis that early administration of pramipexole can modify Parkinson�s disease and delay the progression of motor function deterioration in early PD patients. The PROUD study is unique in its design by including a parallel SPECT imaging arm to measure the level of neuron degeneration in the brain.

534 patients with early PD in 98 centres in ten countries were randomised to receive either 1.5mg/day pramipexole or placebo. After six to nine months all patients were given pramipexole for the remainder of the 15 months. The primary endpoint of the study is the change in UPDRS part I, II and III at 15 months compared to baseline values by a blinded rater. UPDRS part I, II and III relate to mentation, behaviour and mood (I), activities of daily living (II) and motor symptoms (III). Secondary endpoints include the change in motor, cognitive and quality of life indices and striatal dopamine transporter (DAT) density by [¹²³I] FP-CIT SPECT in 158 patients between baseline and 15 months.

^**About CALM-PD
In the earlier performed CALM-PD trial, 301 patients were randomised to double-blind therapy with pramipexole or levodopa; adjuvant therapy was allowed as rescue if necessary. After four years, initial treatment with pramipexole reduced the risk of developing dyskinesias (involuntary jerking movements, themselves very disabling) by more than 50% versus initial treatment with levodopa.²² These results played a pivotal role in recent guidelines by the American Academy of Neurology which support the advantages of starting treatment with a dopamine agonist.²³ While the CALM-PD trial compared the pooled analysis (both mono and combination therapy) after two and four years, this new analysis assessed the effects of mono vs. combination therapy separately in terms of the dyskinesia rate.

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

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.

References:
1 Schapira A et al. PROUD: The impact of early vs. delayed treatment with pramipexole on new onset Parkinson�s disease. Poster P1366 presented at the 12th Congress of the European Federation of Neurological Sciences, Madrid, Spain, 24 August 2008
2 Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs. levodopa on Parkinson�s disease progression. JAMA 2002; 287(13): 1653-1661
3 Jennings DL et al. InSPECT: Investigating the effect of short-term treatment with pramipexole or levodopa on [123I] and SPECT imaging. Abstract 465 at 11th International Congress of Parkinson�s Disease and Movement Disorders, Istanbul 2007
4 Barone P et al. PRODEST � Depressive symptoms in Parkinson�s disease: Pattern across scales. Poster Presentation P-01 / 1.167. 10 December 2007 XVIIth WFN World Congress of Parkinson�s Disease and Related Disorders
5 Koenen-Bergmann, M et al. A multiple rising-dose bioequivalence Phase I study with pramipexole extended release (ER). Poster P1248 presented at the 12th Congress of the European Federation of Neurological Sciences, Madrid, Spain, 24 August 2008
6 Haertter, S et al. A single dose five-way cross-over study to establish an in vitro/in vivo correlation (IVIVC) for oral extended release (ER) formulations with 0.375 mg pramipexole. Poster P1244 presented at the 12th Congress of the European Federation of Neurological Sciences, Madrid, Spain, 24 August 2008
7 Barone P et al. Design of a randomized, placebo-controlled trial of pramipexole in patients with Parkinson�s disease and depressive symptoms (study 248.596) Poster 601 presented at Movement Disorders Society�s 12th International Congress of Parkinson�s Disease and Movement Disorders, June 2008, Chicago, USA
8 M�ller JC et al. Long-term efficacy and safety of pramipexole in advanced Parkinson`s disease: results from a European multicenter trial. Mov Disord 2005 May; 20(5): 602-10
9 Rektorova I et al. Pramipexole and pergolide in the treatment of depression in Parkinson`s disease: a national multicentre prospective randomized study. Eur J Neurol 2003; 10(4): 399-406
10 Reichmann H et al. Pramipexole in routine clinical practice. CNS Drugs 2003; 17(13): 965-973
11 Lemke MR et al. Depression and Parkinson�s disease. J Neurol 2004 Sep;251 Suppl 6:VI/24-7.
12 Lemke MR et al. Anhedonia, depression, and motor functioning in Parkinson`s disease during treatment with pramipexole. J Neuropsychiatry Clin Neurosci 2005 Spring; 17(2): 214-20.
13 Rektorova I et al. Cognitive performance in people with Parkinson`s disease and mild or moderate depression: effects of dopamine agonists in an add-on to L-dopa therapy. Eur J Neurol 2005; 12: 9-15.
14 Goldberg JF et al. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry 2004 Mar; 161(3): 564-6.
15 K�nig G et al. Pramipexole, a nonergot dopamine agonist, is effective against rest tremor in intermediate to advanced Parkinson�s disease. Clin Neuropharm 1999; 22: 301-305.
16 Barone P et al. Pramipexole versus sertraline in the treatment of depression in Parkinson�s disease: a national multicenter parallel-group randomized study. J Neurol. 2006;253(5):601-7.
17 Houben J et al. Pramipexole improves depressive and motivational symptoms in Parkinson�s disease. Abstract no. P575, presented at MDS 2006; Kyoto, Japan.
18 Barone P et al. Depressive symptoms in Parkinson�s disease: Design and methods of an observational study. Mov Disord. Vol. 21, Suppl. 15, 2006: S476.
19 Barone P et al. Depression and antidepressant use in Parkinson�s disease: Results from the PRODEST-PD study. Abstract P1122 poster presented at 11th Congress of EFNS, Brussels, 26 Aug 2007.
20 Zhang ZX, et al. Worldwide occurrence of Parkinson`s disease: An updated review. Neuroepidemiology. 1993;12:195-208.
21 de Rijk MC et al. Prevalence of Parkinsonism and Parkinson�s disease in Europe: the EUROPARKINSON Collaborative Study. European Community Concerted Action on the Epidemiology of Parkinson�s disease. J Neurol Neurosurg Psychiatry. 1997;62:10-5.
22 Parkinson Study Group, Holloway RG et al. Pramipexole vs levodopa as initial treatment for Parkinson disease. Arch Neurol 2004; 61(7): 1044-1053.
23 Miyasaki JM et al. Practice parameter: Initiation of treatment for Parkinson�s disease: An evidence-based review. Neurology 2002; 58; 11-17.

Cymbalta receives european approval for the treatment of Generalised Anxiety Disorder

Thu, 21 Aug 2008 00:00:00 GMT

Indianapolis, 21 August 2008 � Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta^� (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD). This approval - the fourth for duloxetine in Europe was issued on 28 July following an initial positive opinion issued by the European Medicines Agency`s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 26 June 2008.

The approval is based upon the results of five clinical studies of GAD � four double-blind short-term (acute) placebo-controlled studies and a placebo-controlled relapse prevention study � involving more than 2,000 non-depressed adults with GAD. In each of the four acute placebo-controlled studies safety and efficacy were assessed. Duloxetine significantly improved core anxiety symptoms (as measured by the Hamilton Anxiety Scale) compared with placebo (p≤0.001, p=0.02, p=0.007, p≤0.001 respectively)^1-4 and patients demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.^5,6In addition, duloxetine significantly decreased the likelihood of relapse in those patients who initially responded to duloxetine and were maintained on treatment for six months compared with those switched to placebo.⁷ The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis (excessive perspiration), decreased libido, vomiting, ejaculation delay and erectile dysfunction.

Although global prevalence is not currently known, more than nine million Europeans^8,9 and six million people in Central and South America are estimated to suffer from GAD¹⁰, which is characterised by excessive anxiety and worry about a number of events and activities (such as performance at work or school) over a sustained period of at least six months.¹¹

This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the European Union, as well as Norway, Iceland, and Liechtenstein.

Cymbalta^�, a member of a class of drugs commonly referred to as serotonin and noradrenaline reuptake inhibitors,¹² is already approved by the EMEA to treat major depressive disorder and diabetic peripheral neuropathic pain. Duloxetine gained marketing authorisation for the treatment of GAD in Mexico in 2006 and in the United States in 2007.

Notes to Editors:
About Generalised Anxiety Disorder
Approximately nine million Europeans^{8, 9} and six million people in Central and South America are estimated to suffer from GAD.¹⁰ Quality of life is affected as symptoms of GAD can include exaggerated worry or chronic anxiety, irritability and poor concentration. Ability to work is often compromised with the manifestation of physical symptoms such as muscle tension, fatigue, sleep disturbance and nausea.¹¹ The illness tends to be chronic with periods of exacerbation and remission. Patients report that episodes of generalized anxiety disorder are often brought on, or worsened, by stressful life events.¹³

About Duloxetine
While duloxetine�s mechanism of action in humans is not fully known, it is believed to affect both serotonin- and norepinephrine/noradrenaline-mediated nerve signalling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe that duloxetine�s effects on mood and pain are due to an increase in the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved for the treatment of depression and diabetic peripheral neuropathic pain in many countries and is also approved in some countries for the treatment of stress urinary incontinence, Fibromyalgia, Major Depressive Disorder and Generalized Anxiety Disorder. Duloxetine is approved only for adults 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.

Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:

For depression: Nausea, dry mouth, headache, insomnia, diarrhea
For diabetic peripheral neuropathic pain: Nausea, somnolence (sleepiness), fatigue, headache, dizziness
For stress urinary incontinence: Nausea, dry mouth, fatigue
For Generalised Anxiety Disorder: Nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.

(This is not a complete list of side effects.)

Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose them to a potential risk of hypertensive crisis.

Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers � through medicines and information � for some of the world`s most urgent medical needs.

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 almost 38,900 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.

Duloxetine for major depressive episodes is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar^�. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine will be co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve.

New data show Duloxetine maintained pain reduction for more than six months in patients with diabetic peripheral neuropathic pain

Tue, 19 Aug 2008 00:00:00 GMT

Indianapolis, 19 August 2008 � Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months,¹ according to new data presented today at the 12th World Congress on Pain in Glasgow, Scotland.

The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months. The study enrolled 216 patients with DPNP who began eight weeks of treatment with 60 mg of duloxetine once daily. Over this initial eight-week period, 53 percent (N=115) of enrolled patients experienced clinically significant improvement in pain reduction (defined as at least 30 percent pain reduction) as measured by the Brief Pain Inventory (BPI) 24-hour average pain rating.¹ This group of responders was maintained on duloxetine 60 mg (N=103) once daily for up to 26 weeks to evaluate sustained pain reduction. Results at study end showed that the reduction in pain was maintained in 74.8 percent (N=77) of the sustained responders with 60 mg duloxetine over the full study period.

�DPNP is a chronic, potentially disabling, condition requiring treatment over a long period of time,� said Vladimir Skljarevski, M.D., lead author of the study and a neurologist and medical fellow at Lilly Research Laboratories. �This study showed duloxetine reduced pain over a six-month period, making this the longest data analysis of duloxetine for the treatment of DPNP.�

During the course of the eight-week acute therapy and 26-week maintenance therapy periods, the most common treatment-emergent adverse events (those occurring in more than 5 percent of patients) for those taking 60 mg of duloxetine were nausea, somnolence, hyperhydrosis (excessive sweating), dry mouth, anorexia, asthenia (weakness), fatigue and headache.²

An estimated 246 million adults worldwide suffer from diabetes.³ By 2025, that number is expected to rise to 380 million, according to the International Diabetes Federation.³Although all diabetics are at risk for DPNP, those most likely to develop the condition are long-term sufferers whose blood-sugar levels have not been adequately controlled, who have high blood pressure or are overweight.⁴ An estimated 17.2 million to 49.2 million patients with diabetes have been diagnosed with DPNP.⁵

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI). Although it does not treat the underlying nerve damage caused by DPNP, duloxetine does help relieve the intense pain often associated with the disorder.⁶ Scientists believe it does this by increasing levels of serotonin and norepinephrine � two neurotransmitters believed to regulate a person�s sensitivity to pain. Increasing these levels in a balanced way is thought to improve the body�s natural ability to regulate pain by modulating the descending pain pathways in the central nervous system.

In Europe, duloxetine is approved for the treatment of DPNP, major depressive disorder (MDD) and generalised anxiety disorder (GAD).

Duloxetine is approved in various countries outside of Europe for the management of DPNP, for the treatment of MDD, for the treatment of GAD and for the management of fibromyalgia.

Notes to Editors:

About Diabetic Peripheral Neuropathic Pain
Approximately half of those with diabetes have some form of nerve damage, or neuropathy, but not all will develop symptoms. While nerve problems can occur at any time, the highest rates are among those who have had diabetes for at least 25 years.⁴ Symptoms can include numbness, tingling or pain and weakness in the toes, feet, legs, hands, arms and fingers. These symptoms are often worse at night.⁴

About Duloxetine
While duloxetine�s mechanism of action in humans is not fully known, it is believed to affect both serotonin and norepinephrine/noradrenaline mediated nerve signalling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe its effect on pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved for the treatment of major depressive disorder and diabetic peripheral neuropathic pain in many countries and is approved in some countries for the treatment of stress urinary incontinence and generalised anxiety disorder. Duloxetine is approved only for adults age 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.

Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:

for depression: nausea, dry mouth, headache, insomnia and diarrhea
for diabetic peripheral neuropathic pain: nausea, somnolence (sleepiness), fatigue, headache and dizziness
for generalised anxiety disorder: nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhydrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.
for stress urinary incontinence: nausea, dry mouth and fatigue

This is not a complete list of side effects.

Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.

Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with a few exceptions.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers � through medicines and information � for some of the world`s most urgent medical needs.

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 almost 38,900 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.

Duloxetine for major depressive episodes and diabetic peripheral neuropathic pain is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly and Boehringer Ingelheim market duloxetine for major depressive episodes under the brand name Cymbalta, and market the product for diabetic peripheral neuropathic pain as Ariclaim^�. In Greece, Italy and Spain, Lilly markets the product as Cymbalta, and Boehringer Ingelheim markets the product as Xeristar^�. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve^�.

Spiriva�, Micardis� and Flomax� - Boehringer Ingelheim`s highly successful products show good growth. Excellent progress in Research and Development. Strong euro curbs growth. Expenditure in R&D+M reduces operating income.

Thu, 07 Aug 2008 00:00:00 GMT

Ingelheim/Germany, 7 August 2008 - The pharmaceutical company Boehringer Ingelheim continued to post strong growth in local currencies in the first half of 2008 (+9.0%). On account of the strength of the euro against the US dollar and the Japanese yen, growth after consolidation in euro was +2.1% with net sales of EUR�5,522�million compared with EUR�5,407�million in the first six months of 2007.

The operating income of EUR�899�million and also the operating return on sales were down on the previous year. This was caused by exchange rates and expenditure for Research, Development and Medicine in the first half-year, which were significantly higher in comparison to the previous year. The main focus was on clinical research at the core of the research-driven pharmaceutical company.

In the first half year, Boehringer Ingelheim�s sales grew again stronger as the world pharma market. Also for the whole year, Boehringer Ingelheim expects a continued sales growth stronger as the world pharma market and an improvement of the operating income.

For Dr Alessandro Banchi, Chairman of the Board of Managing Directors, the development of sales and income came as expected: "We posted excellent growth in all countries. Business development in the first half of 2008 showed, that Boehringer Ingelheim remains on a healthy growth path and the company continues to outpace the pharma market", Dr Banchi said.

In the first six months of 2008, net sales in the core business Prescription Medicines (PM) increased to EUR�4,354�million, signifying growth of +8.5% in local currencies.

International key brands account for 76% of net sales in the Prescription Medicines business. Spiriva^�, for the treatment of chronic obstructive pulmonary disease (COPD), achieved further strong growth of +23.8% in the first half of 2008 compared with the previous year, with sales of EUR�976�million. The leading cardiovascular product Micardis^�, for the treatment of high blood pressure, attained a marked increase in sales of +11.5% over the previous year to total EUR�603�million. For urological disorders, the company markets Flomax^�/Alna^� for the treatment of benign prostatic hyperplasia. This product achieved growth of +7.3% over the previous year, with net sales of EUR�496�million.

The Consumer Health Care (CHC) business showed positive development with growth of +5.1% in local currencies, to EUR�569�million.

The international CHC key brands, including Dulcolax^�, Mucosolvan^� and Buscopan^�, showed growth of +15% in local currencies.

The Animal Health business made excellent progress, posting growth of +17.4% in local currencies, with sales of EUR�216�million. A key growth driver was the product launch and sales of the Ingelvac^� Circoflex^� swine vaccine.
Sales in the Biopharmaceuticals business amounted to EUR�259� million in the first six months of 2008.

The results of the company`s own Research and Development were extremely gratifying: Pradaxa^� (dabigatran etexilate), an innovative oral direct thrombin inhibitor for the prevention of venous thromboembolic disorders following hip or knee replacement surgery in adults, has now been introduced in the North European countries, after Germany and the United Kingdom. It has now also been approved in Canada and New Zealand. The large-scale study programme in the additional indications of prevention of stroke associated with atrial fibrillation and treatment of acute thrombosis is making good progress, while recruitment has begun for a clinical phase II programme in acute coronary artery disease, e.g. unstable angina pectoris.

The flibanserin phase III studies in the indication hypoactive female sexual desire disorder have been completed according to plan and are currently being evaluated.

All phase III studies required for registration of the antidiabetic compound BI 1356 (Ondero^�) in the indication type 2 diabetes mellitus have now started worldwide. All the studies are proceeding to plan, so the development programme is expected to be completed on time.

Similarly, good progress has been made with the preparation and introduction of the phase III studies with the two oncology compounds BIBW 2992 (Tovok^�) and BIBF 1120 (Vargatef^�).

This half-year once again, overall growth allowed for the creation of new jobs. Compared with the same time a year ago, personnel capacity at Boehringer Ingelheim has increased by +1,468 employees, +3.8%, giving a total headcount of 39,819.

Closure of the tipranavir trials SPRING and TICINO

Tue, 05 Aug 2008 00:00:00 GMT

Ingelheim, Germany, 05 August 2008 - After careful consideration of the feasibility of meeting the enrolment targets for the SPRING (Safety, efficacy and pharmacokinetics of tipranavir boosted with low dose ritonavir (500mg/200mg) twice daily in 400 racially and gender diverse HIV-positive treatment-experienced population) and TICINO (safety and efficacy of tipranavir/ritonavir in treatment-experienced patients also infected with the hepatitis B or hepatitis C viruses) trials, Boehringer Ingelheim has terminated both studies. These trials have been stopped due to poor enrolment and not to any safety or efficacy reasons. Both the EMEA and the FDA are in agreement with the decision to halt these trials.

SPRING was designed to compare the safety and efficacy of tipranavir/ritonavir in a diverse treatment-experienced male and female population. TICINO was designed to compare the safety and efficacy of tipranavir/ritonavir in treatment-experienced patients also infected with the hepatitis B or hepatitis C viruses.

The success of modern HIV treatments including nevirapine has reduced the number of patients experiencing virologic failure on their earlier regimens and the duration of treatment in any line has increased. This is excellent news for those with HIV, but it also means that the original recruitment goals for the trials, 400 patients for SPRING and a further 200 patients for TICINO, was unfeasible. These 600 patients had to demonstrate previous treatment with at least three classes of HIV therapies and show resistance to more than one protease inhibitor drug. It is estimated that both trials would need to be open for more than 15 years to accrue the patient numbers required in order to have a meaningful result.

Boehringer Ingelheim remains committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options for early and late treatment lines.

Aptivus^� (tipranavir), a non-peptidic protease inhibitor which works by inhibiting the viral protease (an enzyme needed to complete the HIV replication process), remains a valuable option for treatment-experienced patients, helping them achieve and sustain viral undetectability even in patients resistant to multiple protease inhibitors.

Viramune^� (nevirapine) is a product of original research done at Boehringer Ingelheim and was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs on the market.

New data shows HIV therapy tipranavir (Aptivus�) is effective and well tolerated in children

Mon, 04 Aug 2008 00:00:00 GMT

Mexico City, 4 August 2008 � Boehringer Ingelheim today presented new 100 week data at the International AIDS Conference demonstrating Aptivus^� (tipranavir) long-term efficacy and safety in treatment-experienced children. Results from this two-year study show that Aptivus^� enabled the children to achieve sustained virologic and immunologic responses and was a well-tolerated antiretroviral therapy.

These results build on the positive 48 week data presented in 2006 at the International AIDS Conference in Toronto and submitted to the FDA for the recent approval of the Aptivus^� paediatric oral solution and paediatric indication in the United States: Data which is also currently being reviewed by the EMEA for a paediatric and oral solution licences in Europe.

This two-year follow-up data evaluated tipranavir co-administered with low dose ritonavir (Aptivus/r) in 78 treatment-experienced children. Those completing the original 48 week trial were given the choice of continuing their therapy with Aptivus^� for an extension of the trial. The continuing analysis confirms the results of the 48 week data and demonstrates the durability of Aptivus^�. Over half of younger children in the trial achieved sustained virologic response and the oral solution continued to be well tolerated over the 100 weeks.

Dr. Manfred Haehl, Corporate Senior Vice President Medicine at Boehringer Ingelheim said, �We are pleased that tipranavir showed such a positive efficacy and safety profile in treatment-experienced children who have fewer treatment options than adults and need more therapy choices, including therapies that have been specially formulated to meet their needs.�

The number of children diagnosed with HIV/AIDS is growing. There are approximately 2.1 million children living with HIV worldwide and recent statistics show that another 29,000 will be infected with the disease this year alone.¹ Once a child is infected with HIV, they face a higher chance of developing AIDS unless they can successfully be treated with antiretroviral therapy. Just as with adults, children can become resistant to certain therapies which underscores the need for an increase in treatment options active against drug-resistant HIV.

The data, collected in over 26 sites in Europe, the United States and Latin America, shows that HIV-1 positive children and adolescents receiving tipranavir boosted by ritonavir as part of their combination antiretroviral therapy can achieve sustained virologic and immunologic responses at 100 weeks of therapy: after 100 weeks of treatment, 56% of children between 2 and 6 years achieved a viral load of less than 400 copies per ml, and 48% of this age group saw their viral loads drop to undetectable levels (less than 50 copies per ml).

For the 6 to 12 years old group, 30% achieved an undetectable viral load (less than 50 copies per ml), and for the 12 to 18 years old group, still over 20% achieved an undetectable viral load. The lower rate of undetectable viral loads in older children is due to them being more treatment-experienced and harbouring HIV which has become more drug-resistant than in younger children.

�There are many children and adolescents with HIV who fail to maintain viral suppression of the disease, which speaks to the urgent need for a new generation of therapies designed specifically for this group,� noted lead author of the analysis and Associate Professor of Paediatrics, Dr. Juan Salazar, MD, MPH, Connecticut Children�s Medical Centre, Hartford, CT, USA. �For these treatment-experienced children who have had limited options for maintaining an active and durable treatment regimen, we now have evidence that tipranavir is effective and tolerable.�

Up to 50% of HIV-infected children and adolescents fail to maintain suppression of HIV replication beyond two years of initial treatment, according to some studies,^2,3 and up to 90% of children who fail antiviral therapy carry drug-resistant strains of HIV. These statistics make it critical that new options are made available which are able to suppress HIV in the treatment-experienced paediatric group.

The most common side effect was gastrointestinal effects such as vomiting and diarrhoea, while over 6% of patients experienced Grade 3 liver enzyme rises (ALT). None of the patients experienced Grade 4 ALT elevations, indicating an acceptable hepatoxicity profile.

About Aptivus^�
Aptivus^� is a non-peptidic protease inhibitor which works by inhibiting the viral protease, an enzyme needed to complete the HIV replication process. Based on available clinical and in-vitro data, Aptivus^� is active against most strains of HIV-1 that are resistant to commercially available protease inhibitors. It is approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors.

RESIST I and II �two large-scale clinical studies on Aptivus^� involving more than 1,400 patients formed the foundation for granting traditional approval by the FDA and full marketing authorization by the EMEA. The RESIST clinical trial program is one of the largest study programs undertaken with an investigational antiretroviral agent in patients previously treated with multiple combinations of antiretroviral drug regimens.

Aptivus^� can be combined with new agents with novel mechanisms of action (e.g. integrase inhibitors and CCR-5 antagonists) without dose adjustment to build efficacious and durable treatment regimens. Such a benefit has been clearly demonstrated by favourable results with the concomitant use of APTIVUS in combination with new drug classes.^4,5

The most commonly reported side effects of at least moderate intensity in patients enrolled in the RESIST studies taking Aptivus^� are gastrointestinal, including diarrhoea, nausea, vomiting and abdominal pain. Fever, fatigue, headache, bronchitis, depression and rash also occurred. Elevated transaminase, cholesterol and triglycerides were more frequent in the Aptivus^�/r arm than in the ritonavir boosted comparator group but only in a minority of cases treatment discontinuation was necessary.

Aptivus^� boosted with low-dose ritonavir has been associated with reports of hepatic adverse events, which have included some fatalities. These have generally occurred in patients with advanced HIV disease taking multiple concomitant medications. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of liver toxicity. The most common moderate to severe laboratory abnormalities were elevated liver enzymes and elevated lipid levels. Most laboratory abnormalities were asymptomatic and most patients were successfully treated without discontinuation.

Aptivus^�-containing HAART regimens have been associated with reports of both fatal and non-fatal intracranial haemorrhage (ICH) in some highly treatment-experienced patients. Caution should be used when prescribing Aptivus^�/r in patients who may be at risk of increased bleeding or who are receiving medications known to increase the risk of bleeding.

Aptivus^� does not cure HIV infection/AIDS or prevent the transmission of HIV to others. Patients may continue to develop opportunistic infections and other complications associated with HIV disease.

Aptivus^� received U.S. marketing authorization by the U.S. Food and Drug Administration (FDA) and was launched in the Unites States in June 2005. On October 4th, 2007, the FDA granted traditional approval for Aptivus^�, and in April 2008 the EMEA granted full marketing authorisation for Aptivus^� in Europe. Additional marketing authorizations from different countries have been received or are expected.

Aptivus^� OS (oral solution) received U.S. marketing authorization for use in treatment experienced children and adolescents by the U.S. Food and Drug Administration (FDA) on 24 June 2008.

About Boehringer Ingelheim HIV Clinical Trials
Boehringer Ingelheim is actively conducting clinical trial programs to further evaluate Aptivus^� and the non-nucleoside-reverse transcriptase inhibitor (NNRTI) Viramune^� for the treatment of HIV-1 infection.

The Viramune^� clinical trial program includes the ArTEN trial, which aims to compare the efficacy and safety of Viramune dosed once or twice daily versus atazanavir boosted with ritonavir in HIV-positive antiretroviral-na�ve patients. The ArTEN trial will enrol 561 HIV-positive patients who have yet to be treated with antiretrovirals.

About Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Aptivus^� (tipranavir), Viramune^� (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune^� was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs on the market. The company is involved in basic research in that area and is committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options.

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.