Boehringer Ingelheim RSS-Newsfeed

Women suffering from Decreased Sexual Desire:Silence hinders diagnosis of the prevalent condition Hypoactive Sexual Desire Disorder(HSDD)

Wed, 07 May 2008 00:00:00 GMT

Ingelheim/ Germany, 07 May 2008 - Data announced at this week�s American College of Obstetricians and Gynaecologists (ACOG) annual clinical meeting suggest that up to one in ten women are suffering from a condition called hypoactive sexual desire disorder (HSDD) with only a third of these seeking advice or help from their healthcare professional.¹ HSDD is a highly prevalent, yet under-diagnosed, medical condition that can have a serious, detrimental effect on women�s quality of life, causing significant psychological distress and negatively impacting their relationships with their partners.^{2, 3}

HSDD is a type of female sexual dysfunction, defined in the Diagnostic and Statistical Manual of Mental Disorders
(DSM-IV) of the American Psychiatric Association, as diminished feelings of sexual interest or desire, absent sexual thoughts or fantasies and lack of responsive desire that causes marked distress or interpersonal difficulties and is not caused by a medical condition or drug.²

According to renowned sexual health expert, Dr Sheryl Kingsberg: "While sex is an everyday topic of conversation within the media and society as a whole, women�s sexual problems are rarely discussed. A decrease in sexual desire has a real and measurable distressing affect on women. The condition impacts almost every aspect of their lives and can become a constant worry". Dr Kingsberg continued: "Both patients and doctors alike can be uncomfortable discussing a woman�s sexual history but we must encourage women to seek professional advice if they feel distressed because their levels of sexual desire have decreased. We are pleased we can now support our colleagues in the diagnosis of this condition as Boehringer Ingelheim has developed a questionnaire, which allows physicians to reliably identify the many women who are suffering from this distressing condition."

Neurotransmitters in the brain and sex hormones both play a role in normal sexual function.³ The brain is central to sexual response and while hormonal treatments may be of benefit to some women who suffer from HSDD, for example those women who have had a surgical menopause through ovarectomy (removal of the ovaries), this is by no means the complete answer for the many millions of women experiencing HSDD.

Boehringer Ingelheim is committed to progressing science and contributing to research in this area of unmet medical need through the Bouquet study programme, which consists of seven phase III studies. This programme investigates flibanserin*, a non-hormonal compound as a potential oral daily treatment for pre-menopausal women suffering from HSDD.

"Flibanserin is currently being researched for its potential to help the many women suffering from HSDD. In my everyday practice I have seen many women with this condition for whom this may mean hope as they search for help", said lead study investigator Dr Evan Goldfischer. "Boehringer Ingelheim is setting a great example with its commitment to researching new potential treatment options such as flibanserin. I am hopeful that their commitment will lead to a real breakthrough for this rarely-discussed medical condition."

The results of the Bouquet Studies will be available in late 2008/09. They will represent an important advance in the understanding of this distressing condition and may offer hope for the many millions of women and their partners affected by HSDD.

About the Bouquet Studies
The Boehringer Ingelheim `Bouquet Study` programme is a group of phase III clinical trials investigating flibanserin* as a potential treatment for women with Hypoactive Sexual Desire Disorder (HSDD), a condition characterized as suffering from decreased sexual desire. Together, the Bouquet Studies aim to demonstrate the efficacy and safety of flibanserin* to support regulatory approval of flibanserin* to treat this common and distressing condition.

The Bouquet Studies comprise seven trials including ROSE, DAHLIA, VIOLET, DAISY, ORCHID, SUNFLOWER and MAGNOLIA and are being conducted by Boehringer Ingelheim in North America and Europe involving over 5,000 pre-menopausal women. The trials are expected to be completed in 2008/09.

Endpoints for the trials are based on guidance received from the FDA and include measuring increases in the level of sexual desire, decreases in distress related to low desire, as well as the number of `satisfying sexual events`. These trials will provide a greater understanding of flibanserin�s* potential as a possible oral daily treatment option for woman suffering from decreased sexual desire.

About Flibanserin*
Flibanserin* is an investigational non-hormonal compound being studied as a potential oral daily treatment for pre-menopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD). The compound works on the central nervous system and acts as a 5-HT1A serotonin receptor agonist and 5-HT2A serotonin receptor antagonist. Research is ongoing to provide additional insight into flibanserin�s* specific mechanism of action.

*This compound is an investigational agent. Its safety and efficacy have not yet been fully established.

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.

European Commission grants full approval of HIV protease inhibitor, tipranavir (Aptivus�)

Mon, 28 Apr 2008 00:00:00 GMT

Ingelheim/Germany, 28 April 2008 - Boehringer Ingelheim today announced that the European Commission has given the full marketing authorisation to its HIV protease inhibitor (PI), Aptivus^� (tipranavir). The Commission has fully approved Aptivus ^� for the suppression of HIV in highly treatment experienced patients who have developed resistance to other protease inhibitors.

Resistance to HIV therapies is a considerable problem, with an increasing number of people developing strains of HIV that are resistant to protease inhibitors. For example, in one study in the UK 27% of treatment-experienced patients demonstrated resistance against protease inhibitors ¹ and in Spain, 43% of patients treated for more than eight years carry more than five protease resistance mutations. ²

Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said: �We welcome this decision by the EU Commission to grant full marketing authorisation for Aptivus^�. This full approval demonstrates the confidence that the authorities have in the benefit of Aptivus^� for patients with resistant virus.�

Aptivus^�, the first non-peptidic protease inhibitor, shows good antiviral activity against viruses that have shown decreased susceptibility to other currently marketed PIs.³

The decision to grant full marketing authorisation was taken on the evidence of two large multicentre pivotal trials (RESIST I and II) demonstrating Aptivus^� superiority across several efficacy measures to a group of comparator PIs boosted with ritonavir. Treatment response rates^* over 156 weeks were almost three times higher in the Aptivus^� arm compared to the comparator arm (20.9% vs. 7.5%) and were markedly higher for those patients who also started a new class of HIV therapy (here: Enfurvitide). ³

With over 1,400 participants ⁴ the RESIST trials are one of the largest studies ever of treatment-experienced patients. The data demonstrate that Aptivus^� enables treatment-experienced patients to achieve and sustain undetectable viral loads, one of the most important goals of therapy. This efficacy, alongside the acceptable safety profile of Aptivus�, as seen in more than 20.000 patient years of use of Aptivus^�, prompted European authorities to remove the �exceptional circumstances� restriction on the marketing authorisation, previously granted in 2005.

Holger P., a patient from Frankfurt, Germany, who has been treated with nearly all the 22 currently available HIV drugs, said: �This full approval is good news for treatment experienced patients like me. It gives us the confidence that our therapies have passed the rigorous tests demanded of them. With drugs like tipranavir available to us, we can, regardless of our treatment experience, aim for an undetectable viral load.�
^* (Media who would like to interview Holger P. please email press@boehringer-ingelheim.com for further details).

Attaining an undetectable viral load has been shown in several studies to prolong survival and reduce the risk of AIDS or death by more than 80% in people with HIV that have become resistant to multiple therapies and classes of therapies.^5,6

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. It is approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors.

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.

Currently, phase II and III studies in paediatric and other populations are fully enrolled and ongoing.

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 hemorrhage (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.

Apart from the EU, Aptivus^� received U.S. marketing authorization by the FDA and was launched there in June 2005. On Oct 4th, 2007, the FDA granted traditional approval for Aptivus^�. Additional marketing authorizations from different countries have been received or are expected.

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.

POTENT is a trial comparing the efficacy and safety of Aptivus^� (tipranavir) versus darunavir, both with ritonavir as part of combination antiretroviral therapy. POTENT will include 800 treatment-experienced patients in 15 countries. The primary endpoint is time to virologic failure, with a secondary endpoint of virologic response at 48 weeks of treatment.

SPRING study will be one of the largest racially and gender diverse international studies of highly treatment-experienced HIV-1 infected patients. The trial will examine the safety, efficacy and pharmacokinetics of Aptivus^� (tipranavir) in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries in three continents.

RESIST I, II �two large-scale clinical studies on tipranavir involving more than 1,400 patients (RESIST-I and RESIST-II) formed the foundation of the marketing authorization approval 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.

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.

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.

^* as a confirmed 1 log10 or greater decrease in viral load from baseline.

Data suggests promising overall survival and progression-free survival with Vargatef� (BIBF 1120)

Fri, 25 Apr 2008 00:00:00 GMT

Ingelheim/ Germany, 25 April 2008 - Monotherapy treatment with the triple angiokinase inhibitor¹ BIBF 1120 (planned tradename Vargatef �) offers promising efficacy and is well tolerated in patients with advanced, relapsed non-small cell lung cancer (NSCLC), according to results from a phase II study in patients with lung cancer². Of particular note were results from a subset of 57 patients with �good disease state� (ECOG performance status^* of 0 or 1): these patients experienced longer overall survival (median overall survival was 9.5 months), longer progression-free survival (PFS; median PFS was 2.9 months) and a higher stable disease rate of 59% compared with the overall study population. The results were presented today by Dr Joachim von Pawel from Asklepios Fachkliniken M�nchen-Gauting, Germany, at the 1st European Lung Cancer Conference jointly organized by IASLC and ESMO in Geneva, Switzerland.

BIBF 1120, administered as a capsule taken twice daily, is currently being developed by Boehringer Ingelheim and is one of the company�s most advanced molecules within the cancer development portfolio. BIBF 1120 is a novel triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)¹ � all of which are crucially involved in the formation of blood vessels.

Commenting on these results, Dr von Pawel stated in Geneva: �This study is very encouraging because it tells us that BIBF 1120 has good efficacy when administered on its own. The substantial clinical effect observed in the subset of 57 patients with �good� performance status (ECOG 0�1) is very notable and gives us great impetus to continue fully exploring the potential of this molecule.� BIBF 1120 was also well tolerated by patients in this study, which is a very important consideration for cancer patients and their physicians. �The most important clinical question for us to address now is how much benefit patients may derive from BIBF 1120 treatment and the place this potential medicine may have in the cancer clinic of the future,� he added.

Study design and results
This phase II study investigated the efficacy of BIBF 1120 in 73 patients with an ECOG score of 0�2 with locally advanced or metastatic NSCLC (stage 11B/IV)². Patients with all histologies were eligible to enrol. All patients in the study had previously received at least one line of platinum-based therapy. The primary endpoints were PFS and objective tumour response (measured by RECIST criteria). Secondary endpoints included overall survival (OS) and safety. Patients were randomized to receive either BIBF 1120 250 mg capsule twice daily (n=36) or 150 mg capsule twice daily (n=37). Results reported were:

All patients, ECOG 0�2 (n=73):

Median PFS was 1.7 months in the overall study population, which included 16 patients with ECOG PS 2. Nearly one in two patients (48%) experienced disease control (defined as Partial Response [PR] + Complete Response [CR] + Stable Disease [SD]). There was no difference in efficacy between the two dose treatment arms.
Median OS of all patients was 5.5 months.

ECOG performance status 0 or 1 (n=57):
BIBF 1120 showed a substantial clinical effect in the subset of 57 patients with �good� performance status (ECOG 0�1):

Median PFS was 2.9 months and disease control rate was 59%; there was no difference between both treatment arms.
Median OS in this group was 9.5 months.

The study authors reported that BIBF 1120 administered orally twice daily was generally well tolerated. The most frequent adverse events reported in this study were nausea, diarrhoea and vomiting, and they were mostly mild to moderate.

Dr Andreas Barner, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim, commented: �These new BIBF 1120 phase II data, coupled with evidence from previous studies^3,4 that show BIBF 1120 is well tolerated in combination with standard lung cancer treatments, gives us great confidence in moving forward with further investigations of BIBF 1120 in lung cancer. We are pleased to report we are making great progress in our oncology research programme and we look forward to presenting further data from our franchise during 2008.�

About BIBF 1120
BIBF 1120 is a novel triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)1. These growth factors and receptors play an important role in angiogenesis; their inhibition plays a critical role in the prevention of tumour growth and spread.

To date, more than 400 patients have been treated with BIBF 1120 through enrolment in phase I and phase II clinical trials. In two phase I studies^3,4, the dose for BIBF 1120 in combination with pemetrexed or carboplatin/paclitaxel has been determined to be 200 mg twice daily. BIBF 1120 was well tolerated by patients in both studies.

About ECOG

Grade	Eastern Cooperative Oncology Group (ECOG) performance status
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2	Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3	Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4	Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5	Dead

About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs.

Boehringer Ingelheim is committed to discovering and developing novel cancer treatments that have the potential to provide significant clinical and quality of life benefits for patients. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including various solid tumours and haematological cancers.

The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. BIBW 2992 (a signal transduction inhibitor) is now entering phase III clinical development and phase III development for BIBF 1120 (a triple angiokinase inhibitor) is planned for 2008. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing novel, potent and highly selective inhibitors of polo-like kinase 1 (Plk1), a protein that is involved in the processes of cell division. These molecules are in the early stages of clinical development.

Boehringer Ingelheim is working in close collaboration with the international scientific community and a number of the world�s leading cancer centres to research and develop these potential new treatments for cancer.

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 USA.

* ECOG Definition: The Eastern Cooperative Oncology Group performance status are scales and criteria used by doctors and researchers to assess how a patient`s disease is progressing, assess how the disease affects the daily living activities of the patient, and determine appropriate treatment and prognosis.

New data confirm pramipexole (Mirapexin�/Sifrol�) can significantly reduce sleep disturbance for people with Restless Legs Syndrome (RLS)

Thu, 17 Apr 2008 00:00:00 GMT

Ingelheim/Germany, 17 April 2008 - A new study has shown that pramipexole (Mirapexin^�/Sifrol^�) can significantly reduce sleep disturbance, often the most troublesome symptom experienced by people with Restless Legs Syndrome (RLS).¹ The important finding, presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, U.S.A., highlights the benefit of an RLS treatment which effectively targets the core symptoms of the condition, such as an uncontrollable urge to move the legs as well as secondary symptoms including sleep disturbance. For the many people affected by Restless Legs Syndrome, this means that overall sleep patterns and quality of life can be greatly improved with pramipexole, - a fast-acting treatment which has been shown to bring relief already after one night.²

According to Professor Luigi Ferini-Strambi from the Sleep Disorders Center, Universit� Vita-Salute, San Raffaele, Milan (Italy) and lead author of the study: �Most people with RLS who seek medical advice have often suffered for a long time from sleep deprivation due to the debilitating impact of RLS. To feel the benefit of a simple, effective treatment right from the start, is a huge step forward for these patients. Beyond enabling them to sit comfortably through an evening, they can look forward to a night of sleep without being disturbed by the uncontrollable urge to move their legs. For many people with RLS, this means that they can finally start regaining their quality of life.�

In the study, a randomised, double blind and placebo controlled trial in adults with scores >15 on the International RLS Study Group Rating Scale (IRLS) and symptoms at least 2-3 times per week, improvements were assessed based on the MOS* sleep scale. The study was the first-ever evaluating the effect of pramipexole on sleep, using a multi-dimensional patient-reported instrument. Sleep disturbance scores for the patient group treated with pramipexole were reduced from 52.5 to 27.8 after 12 weeks from baseline compared to 55.6 to 38.5 in the placebo group (p=0.0001), i.e. the pramipexole treated patient group reaching a near to normal level, and in some instances already after the first night of treatment² (a score of 24.5 is considered normal).¹

Although worsening of symptoms at night is a hallmark of RLS, many people with RLS also experience bothersome symptoms during the day. Furthermore, daytime function is also disrupted by somnolence due to sleep disturbance, further heightening the need for fast acting treatment options that effectively treat both the night and daytime symptoms of the condition.

In a study assessing the rapid onset and sustained efficacy of pramipexole, rapid symptom improvements were shown after the first intake, reached their peak after four weeks and were maintained throughout the 12 week trial. Adjusted mean changes from baseline on IRLS were greater for pramipexole at all item points: day 9, day 14, week 4 and week 12 (p<0.0001 for all versus placebo). Patient Global Impression (PGI) responder rates were improved over placebo at day 1 (16.4% vs 8%), day 5 (36.2% vs 15.2%), day 9 (44.1% vs 19.6%), day 14 (53.1% vs 34.1%), week 4 (65.7% vs 39.7%) and week 12 (62.9% vs 38%).²

The effect of pramipexole on daytime symptoms of RLS was shown in another study. This study showed a median baseline of 4.0 in both severity of daytime symptoms at rest and daytime sleepiness, as measured with the RLS-6 scale (0 = none/not at all, 10 = very severe). At week 12, the median reduction was ﷓2.0 (pramipexole) versus -1.0 (placebo) for daytime RLS severity (p = 0.0017) and -2.0 versus -1.0 (p = 0.0024) for daytime sleepiness.³

Overall the data presented at AAN reaffirm pramipexole as a highly effective and fast-acting treatment for Restless Legs Syndrome, in many cases even at the lowest dose and already after one night. Pramipexole not only alleviates the very unpleasant and sometimes painful feelings in the legs experienced by patients with RLS during periods of rest, but can also improve daytime RLS symptoms.

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 the Editor:
*Medical Outcomes Study (MOS) sleep scale
The MOS Sleep Scale is a self-administered scale measuring specific aspects of sleep (problems with sleep disturbance [initiation and maintenance], adequacy, somnolence, quantity, respiratory impairments and snoring). It was designed for use in patients who may have varying co-morbidities. The frequency with which each problem has been experienced during the previous 4 weeks is rated on a 6-point scale ranging from `none of the time` to `all of the time`, except sleep quantity, which is reported in hours. All scores are transformed linearly to range from 0 to 100 with the exception of the sleep quantity subscale, which is scored in hours. Higher scores indicate more of the attribute implied by the scale name (e.g. more sleep disturbance, more adequate sleep, greater sleep quantity).

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 years⁴ 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 in Europe under the trade names Mirapexin^� and Sifrol^� and in the U.S.A. as Mirapex^�) 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 registered in over 80 countries across the globe.

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

First ever European Porcine-Circovirus-Research-Award Winners honoured

Thu, 17 Apr 2008 00:00:00 GMT

Ingelheim/Germany, 17 April 2008 - Prof. Hans Nauwynck, Prof. Joaquim Segal�s as well as Danja Wiederkehr together with Dr. Xaver Sidler are the winners of the first ever European PCV2¹ Research Award, initiated and sponsored by Boehringer Ingelheim Animal Health.

The awards were recently presented to the award winners by Prof. Maurice Pensaert, former head of the Laboratory of Virology of the Ghent University and Dr. Gerald Behrens from Boehringer Ingelheim Animal Health during an official ceremony at the global headquarters of Boehringer Ingelheim in Ingelheim, Germany.

The award honours convincing proposals for research projects in the area of applied immunological PCV2 research. The winning research projects outlines were:

A new approach for the set up of a reproducible model of PMWS² in pigs (Prof. Hans Nauwynck, Ghent University, Belgium). PMWS in pigs is characterized by poor growth (wasting) and increased mortality. To date it is not possible to induce these clinical signs by artificial infection with PCV2 in a reproducible model. With his work Hans Nauwynck aims to close this gap.
The impact of genetic diversity of PCV2 isolates on vaccine efficacy (Prof. Joaquim Segal�s, University of Barcelona and CReSA, Spain). Joaquim Segal�s is going to investigate if a novel one-shot PCV2 piglet vaccine protects against both recently described types of PCV2, genotype 1 and 2.
The differences in pathogenicity of Porcine Circovirus type 2 (PCV2) subgenotypes in Switzerland (Danja Wiederkehr and Dr. Xaver Sidler, Vetsuisse University, Zuerich, Switzerland). Danja Wiederkehr and Xaver Sidler try to identify which parts of the PCV2 genome are responsible for disease expression.

European Porcine Circovirus (PCV2) Research Award
The European Porcine Circovirus (PCV2) Research Award is an annual award that recognizes research proposals in the area of applied immunological PCV2 research. In total, 75,000&eusro;, three prizes of 25,000� each are granted to European researchers who convince the independent jury with their outline of innovative research approaches in the field of swine immunology to explore Porcine Circovirus Disease (PCVD).

With the award Boehringer Ingelheim Animal Health aims to promote further scientific progress to better understand and ultimately control this devastating swine disease.

The European PCV2 Award has an independent judging panel with leading European scientists in applied porcine research reviewing the entries and deciding upon the winning proposals. The panel is chaired by Professor emeritus Maurice Pensaert from the Laboratory of Veterinary Virology at the University of Ghent in Belgium.

How to apply
Applications for the next European PCV-2 Research award can be submitted by September 15, 2008, via email to Maurice.pensaert@ugent.be or to Petra.Maass@boehringer-ingelheim.com.

Research Proposals that suggest innovative approaches in the field of vaccine immunity, maternal immunity or interaction of PCV-2 with other potential pathogens are eligible.

Proposals shall not exceed 6 pages and must meet the following formal requirements:

One page CV of the researcher who is directly responsible
Introduction including literature review
Objectives of the research proposal.
Work programme, incl. estimated timelines
Reference list (also indicate own references in PCV-2 research)

Newly established research teams are specifically encouraged to submit proposals.
Researchers from the NAFTA region can submit entries to the American Annual PCV Associated Diseases Research Award Program, a similar annual award sponsored by Boehringer Ingelheim Animal Health which has been launched in North America in June 2006.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world�s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

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.

¹ PCV 2 = Porcine Circovirus Type 2
² PMWS = postweaning multisystemic wasting syndrome

New powerful antihypertensive MicardisPlus� 80/25 (80mg telmisartan/25mg hydrochlorothiazide) approved by EU Commission

Mon, 14 Apr 2008 00:00:00 GMT

Ingelheim/Germany, 14 April 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the new powerful strength of their fixed dose combination antihypertensive drug MicardisPlus^� 80/25 in all 27 EU member states. It will be launched in Germany and Denmark in the coming weeks, followed soon by Ireland, the United Kingdom and the rest of EU, and when approved also in other countries around the world.

The product is licensed for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on MicardisPlus^� 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages. ^1,2

The new strength will be marketed by Boehringer Ingelheim in all 27 countries of the European Union under the brand name MicardisPlus^�80/25. It�s co-marketing partners will market the new drug in selected countries under their own brands.

�The approval of MicardisPlus^�80/25 provides physicians with a powerful new drug for patients with difficult to treat essential hypertension�, said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine.

European approval of MicardisPlus^� 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of two consecutive trials designed to demonstrate the superiority of the fixed dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5).² 971 patients, who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the programme. Treatment with T80/H25 provided superior diastolic and systolic blood pressure lowering power after 8 weeks of treatment¹compared to T80/H12.5. In the consecutive follow up trial 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for further 6 months. At the end of this treatment interval the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.²

No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified^1,2. Other studies considered by the EMEA showed clearly superior clinical benefits for a T80/H25-based treatment compared with 160 mg valsartan /25 mg hydrochlorothiazide, the market leading ARB�s high strength combination. ³

Landmark trial ONTARGET^�proves cardio & vascular protective effects of telmisartan
Boehringer Ingelheim continues to explore new strategies to improve cardiovascular therapy: The results of ONTARGET^�(The ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) with 25,620 patients have recently proven that telmisartan is as protective as the current gold standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke and hospitalisation for congestive heart failure in a broad cross section of high-risk cardiovascular patients. With 25,620 high-risk patients followed up for up to 6 years ONTARGET^�was the largest ARB outcome trial ever. �The ONTARGET^�results have important implications for the management of patients with cardiovascular diseases. We now have a new treatment option for high-risk patients which is effective and better tolerated,� comments Salim Yusuf, lead investigator of the ONTARGET^�Trial Programme and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada.

Evidence for renal protective effects of telmisartan
Further evidence of the exceptional properties of telmisartan has already been seen in previous trials. In 2007, the AMADEO^�trial showed that telmisartan achieved significantly greater reduction in proteinuria compared with the ARB losartan beyond blood pressure reduction effects, demonstrating the potential for renal protection with telmisartan in diabetic patients.⁵

Proven powerful antihypertensive efficacy
In addition, in 2006 the PRISMA^TM trials in hypertensive patients demonstrated that telmisartan achieved more powerful blood pressure reductions over the full 24hour period compared with the ACE-inhibitor ramipril. ^6,7

- ends -

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.

About ONTARGET^�
The ONTARGET^� Trial Programme consists of two randomised, double-blind, multicentre international trials: the principle trial, ONTARGET^� which reports its results today, and a parallel trial TRANSCEND^� (Telmisartan Randomized AssessmeNt Study in ACE-I INtolerant subjects with cardiovascular Disease), which is planned to be reported later in the year.³

The treatment arms for the ONTARGET^� Trial were telmisartan 80mg, ramipril 10mg, and combination therapy with telmisartan 80mg and ramipril 10mg. In the TRANSCEND^� trial the treatment arms are telmisartan 80mg or placebo � both on top of standard blood pressure care, not including an ACE or another ARB.³

Patients enrolled in The ONTARGET^�
Trial Programme were aged ≥ 55 years, had a history of coronary artery disease, stroke or recent (> 7 days, < I year) transient ischaemic attack, peripheral vascular disease, or diabetes mellitus with target-organ damage such as microalbuminuria, ankle-brachial index < 0.8, or left ventricular hypertrophy.⁸

The ONTARGET^� Trial had a four-fold composite endpoint:

cardiovascular death,
myocardial infarction,
stroke, and
hospitalisation for heart failure.

Patients intolerant to ACEs were not eligible for the ONTARGET^� study. Intolerance to ACE was a requirement for enrolment into TRANSCEND^�.

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.

Boehringer Ingelheim outpaces the market yet again in 2007Spiriva�, Micardis� and Flomax� are the major products A host of compounds in the pipeline from own research and development

Tue, 08 Apr 2008 00:00:00 GMT

Ingelheim/Germany, 8 April 2008 - Boehringer Ingelheim enjoyed continued success through 2007, its growth outpacing the pharmaceuticals market for the eighth time in succession. As the Company announced at its Annual Press Conference in Ingelheim, turnover rose by +8.8% in local currency (+3.6% in euro terms) to almost EUR 11 billion (2006: EUR 10.5 billion). At EUR 2.1 billion, operating income - comparable to the EBIT - is at the previous year`s level. This corresponds to an operative margin (ratio of operating income to net sales) of 19.2%. Income after tax was a good EUR 1.8 billion, signifying an increase of +4.8% over the previous year. The number of employees worldwide rose by almost 1,400 to around 39,800 (an increase of +3.6%). For 2008, Boehringer Ingelheim also expects in local currencies a high single-digit net sales growth and thus slightly above the market level.

Dr Alessandro Banchi, Chairman of the Board of Managing Directors of Boehringer Ingelheim and Head of the Corporate Board Division of Pharma Marketing and Sales, said: �We can look back once again on a successful year for Boehringer Ingelheim with continued growth in 2007. Our products are benefiting patients, our product pipeline is well equipped and our workforce is highly motivated.�

At the same time, the Company faced two major challenges in 2007: firstly, the strength of the euro against the US dollar and the Japanese yen and secondly, a sharp fall in net sales compared to 2006 for the product Mobic^�, the US patent of which expired in 2006. Overall, a fall in net sales of EUR 340 million for this product had to be offset. In addition, currency effects resulted in a loss of more than 5% on the previous year`s turnover.

The fact that Boehringer Ingelheim successfully achieved growth of +3.6% in euro terms despite these challenges, highlights the excellent dynamic growth of its product portfolio.

According to calculations by the healthcare information service, IMS, Boehringer Ingelheim grew by +7.1%, thus once again outpacing the pharmaceutical market which experienced growth of +6.0%. In 2007, Boehringer Ingelheim again secured a stable market share of almost 2%, ranking 15th among the international pharmaceutical companies.

Our pharmaceutical products provide patients with real therapeutic benefits
In 2007, the Company`s prescription medicines again enjoyed a very high degree of acceptance, resulting in a significant improvement in their respective market position. All core products achieved a significant rise in sales in 2007 and have further potential for future growth.

Leading the way is Spiriva^� (tiotropium bromide), the world`s foremost drug for the treatment of chronic obstructive pulmonary disease (COPD), sales of which rose by +35% in local currency terms to just under EUR 1.8 billion. Also, after registration in the EU in autumn 2007, the Respimat^� Soft Mist� Inhaler with Spiriva^� was launched in Germany, Denmark, the Netherlands and the United Kingdom. Market launches in more countries are to follow in 2008. The great demand for this product among patients and doctors demonstrates that with its COPD drug in an innovative inhaler Boehringer Ingelheim has achieved a further major breakthrough.

Micardis^� (telmisartan), a particularly effective and well tolerated angiotensin receptor blocker (ARB) with the longest duration of action in this drug class and used for the treatment of essential high blood pressure, achieved net sales of EUR 1,123 million as well as growth of +23% in local currency terms. Flomax^�/Alna^� for the treatment of benign prostatic hyperplasia achieved net sales of EUR 1,020 million and growth of +19% in local currency terms. In addition, Sifrol^�/Mirapex^� (pramipexole) for the symptomatic treatment of Parkinson`s disease and for the treatment of moderate to severe cases of restless legs syndrome achieved net sales of EUR 644 million euro and growth of +26% in local currency terms. And also Aggrenox^� (dipyridamole extended release/ASA), a medication for secondary stroke prevention, generated gratifying net sales of EUR 278 million and a growth of +32% in local currency terms.

Boehringer Ingelheim`s business areas
Business in the most important strategic business area, Human Pharmaceuticals, Prescription Medicines accounts for 79% of the total net sales of Boehringer Ingelheim. Here, net sales rose in 2007 by almost +10% in local currency terms (+4.2% in euro terms) to over EUR 8.6 billion, following adjustment to take account of the currency component. The self-medication business increased by +11.7% in local currency terms (+7.2% in euro terms) to EUR 1.14 billion.

Total net sales of the Industrial Customer business (Biopharmaceuticals, Pharmaceuticals Production and Pharma Chemicals) amounted to EUR 739 million and thus below the previous year`s figures (-6.5% after currency adjustment, -8.6% in euro terms). In addition to the effects of exchange rates, the fall in net sales in the biopharmaceuticals segment is also partly due to the fact that planned technical upgrades of the older of the two Biberach plants rendered the plant inoperable for several months.

Boehringer Ingelheim`s strategic business areas also include Animal Health. As a leading international supplier of animal health products, Boehringer Ingelheim was able to continue its pleasing growth of recent years with an increase in net sales of +13.1% in local currency (+9.1% in euro terms) to EUR 408 million. Steady growth has been seen in porcine vaccines, in particular. Boehringer Ingelheim is thus well on the way to becoming the market leader in the porcine vaccines segment.

The growth of Boehringer Ingelheim in 2007 was evident in all three regions. Last year, North and South America was again the region with the strongest turnover of the company, where net sales exceeded EUR 5.4 billion (2007: EUR 5.3 billion). In spite of stagnating development in euro terms, the USA remains the principal driving force for growth and, with its net sales of EUR 4.5 billion (approx. +12% in local currency terms), made the largest contribution to global net sales and profits.

The strongest growth amongst the regions was achieved in Europe with net sales of EUR 3.6 billion (+ 8.6% in local currency terms) and a share of total net sales of just under 33%. The strongest country in this region was once again Germany with total net sales of EUR 853 million, although prescription medicines accounted for only EUR 444 million of this figure.

The Asia, Australia, Africa (AAA) region achieved net sales of EUR 1.9 billion and accounted for 17.5% of the worldwide net sales of Boehringer Ingelheim. With net sales of EUR 1.2 billion, Japan was the strongest country in this region.

Exchange rate fluctuations also significantly influenced growth in the AAA region; for this reason, net sales in euro managed only a slight increase on last year`s figure.

Professor Muff highlighted the very solid financial figures and the Company`s desire to secure its long-term independence as a research-driven pharmaceutical company in an increasingly high-risk environment. �Lasting independence is only possible if the critical factors, i.e. liquidity, profitability and potential for success of the development pipeline, actually guarantee financial security both now and in the future. In this regard, we see good prospects for our company in the medium to long term�, Professor Muff said.

Yet it was also necessary, he said, to keep mindful of long-term trends and increasing risks for the pharmaceutical industry, particularly the incentive systems set up by the competent authorities to launch costly research and development of new drugs that represent advances in treatment.

Our employees � the key requirement for future success
Dr Banchi and Professor Muff emphasised that the Company attaches particular value to its employees who are the causal force behind the Company`s innovation and thus the key prerequisite for its future development. They said that it is a special pleasure for Boehringer Ingelheim to take first place in the 2007 Top Employers Survey conducted by the journal Science and to thus be deemed the most attractive employer for science professionals in Europe and the USA.

Since 2003, the number of employees worldwide has increased by approximately 5,500, or +16%. In Germany alone, 1,700 new employees were recruited, corresponding to an increase of +17%. The increase in employee numbers also demonstrates the continued pledge to monitor and improve internal processes and structures. One particular challenge - and also a challenge for Boehringer Ingelheim - was said to be the demographic development in many countries which is being acted upon with relevant measures as part of the broad-based initiative, �Perspective Demography�.

New product launches and a host of products in the pipeline � securing the future
Dr Banchi sees positive prospects for the future, with 2008 being a particularly important year for the further development of the Company.

End of March 2008, Pradaxa^�, the first oral anticoagulant from the class of direct thrombin inhibitors and a product from Boehringer Ingelheim�s own R&D, was successfully approved by the European Commission in its first indication for the prevention of venous thromboembolic events in adults after elective hip and knee replacement surgery. A further four indications are currently in clinical development. �We are convinced that in the future, Pradaxa^� will be important for even more patients and doctors for a variety of conditions and after more than 40 years of vitamin K antagonists being the gold standard, it will change current treatment guidelines for the prevention of venous thromboembolism,� Dr Banchi said.

2008 will also be marked by the publication of various landmark studies (Phase IV studies). The first study to be published were the results of the ONTARGET� study on the protection of cardiovascular events, which showed that telmisartan (Micardis^�) is as protective as the current gold standard ramipril, but significantly better tolerated in a broad high-risk cardiovascular population. Telmisartan (Micardis ^�) is the first and only angiotensin receptor blocker (ARB) to have proven cardiovascular protective benefits beyond blood pressure reduction in patients with high cardiovascular risks.

Other important results are expected in 2008 for the PRoFESS^� study involving Aggrenox^� and for the UPLIFT^� study involving Spiriva^�. �Positive results from the studies mean new medical findings as well as widened and new indications for our drugs, thereby benefiting the patients,� said Dr Banchi.

In addition, several innovative substances from our own R&D for various therapeutic areas have progressed to the next clinical development phase. Clinical phase III includes two substances from oncology, one substance for diabetes type II and one substance in development for pre-menopausal women with hypoactive sexual desire disorder.

Our own R&D is also enhanced by promising cooperative alliances and licensing agreements with other companies. In 2007, over EUR 1.7 billion was invested in research, development and medicine, representing an increase on the previous year of just under +10%. Research spending thus accounted for more than 19% of sales in prescription medicines.

Dr Banchi: �We are very optimistic as our financial basis is sound and our prospects are encouraging. And with the forthcoming new product launches and our products in the pipeline, we have once again proved our company`s power of innovation and potential for success.�

Landmark trial ONTARGET� proves telmisartan is as protective as ramipril and better tolerated in a broad high-risk cardiovascular population. From ONTARGET� it may be concluded that telmisartan can prevent every 5th serious cardiovascular event.

Mon, 31 Mar 2008 00:00:00 GMT

Ingelheim, Germany, 31 March, 2008 � The results of the landmark ONTARGET^� Trial have proven that telmisartan, brand name Micardis^�, a modern angiotensin II receptor blocker (ARB), is as protective as the current gold standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke, and hospitalisation for congestive heart failure in a broad cross-section of high-risk cardiovascular patients and with better tolerability.¹ These cardiovascular events occurred in 16.66% of patients receiving telmisartan versus 16.46% of patients receiving ramipril.¹ The relative risk (ratio of the probability of the event occurring in the telmisartan group versus the ramipril group) was 1.01, with a 95% CI of 0.94 -1.09.

In 2000, the HOPE trial showed that the cardiovascular risk for patients treated with ramipril is reduced by approximately 20% compared with placebo.² This meant that every fifth serious cardiovascular event in a high risk group of patients was prevented. A similar effect can now be attributed to telmisartan. The 25,620 high-risk patients in the ONTARGET^�Trial were already receiving standard care such as statins to lower cholesterol, antiplatelet therapy, betablockers and other antihypertensives.³ Telmisartan was also shown to be significantly better tolerated than ramipril, a widely used angiotensin converting enzyme inhibitor (ACE), with respect to typical ACE-inhibitor side-effects.¹ Although patients with an ACE-inhibitor intolerance had been excluded from the trial, 360 patients in the ramipril treatment arm stopped their treatment because they experienced cough versus only 93 patients in the telmisartan arm. 25 patients stopped their treatment in the ramipril arm because of angioneurotic edema, versus only 10 in the telmisartan arm.¹

The ONTARGET^� data also show that telmisartan is associated with a higher treatment compliance.¹ Besides efficacy, tolerability and compliance are also important factors to consider as they are crucial for effective long-term treatment for the prevention of serious cardiovascular events.

Telmisartan is now the only angiotensin II receptor blocker (ARB) to have proven cardio & vascular protective benefits beyond blood pressure reduction in this high-risk population.¹ Until now, only the ACE-inhibitor ramipril had shown these protective effects.²

ONTARGET^� also studied the value of combining telmisartan with ramipril, to answer a key question for the clinical community � does combining an ACE inhibitor and an ARB, i.e. the dual renin-angiotensin system (RAS) blockade, offer even better protection compared to single blockade? The results announced today indicate that there is no additional protective benefit achieved for the overall patient population, if ramipril and telmisartan are combined.

Implications of the ONTARGET^�Trial
�The ONTARGET^� Trial shows that telmisartan is a well-tolerated treatment in high-risk cardiovascular patients that is as effective as ramipril in preventing heart attacks, stroke, hospitalisations for heart failure and deaths�, said Professor Salim Yusuf, lead investigator of the ONTARGET^�Trial Programme and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada. �The ONTARGET ^� results have important implications for the management of patients with cardiovascular diseases. We now have a new treatment option for high-risk patients which is effective and better tolerated.�

Largest ARB outcome trial ever
ONTARGET^�is a randomised, double-blind clinical trial, which evaluated 25,620 high-risk cardiovascular patients with normal or controlled blood pressure over an observation period of up to 6 years.

�We are proud to have started ONTARGET^�, the largest outcome cardiovascular trial ever undertaken with an ARB. It included high-risk cardiovascular patients with a history of coronary heart disease, stroke, transient ischaemic attack, peripheral vascular disease or diabetes with target organ damage. The trial has an extremely robust data base that will enable the medical community to answer questions where no scientific proof was available before. With 99.8% of patients followed over these years, this is one of the best managed landmark trials ever. We owe this excellent management of the trial to the investigators in over 700 centres across 40 countries led by Professor Salim Yusuf and his team at McMaster University, Hamilton, Canada.� said Dr Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine.

Benefits related to exceptional properties and structure of telmisartan
Further evidence of the exceptional properties of telmisartan has already been seen in previous trials. In 2007, the AMADEO trial showed that telmisartan achieved significantly greater reduction in proteinuria compared with the ARB losartan beyond blood pressure reduction effects, demonstrating the potential for renal protection with telmisartan in diabetic patients.⁴ In addition, in 2006 the PRISMA trials in hypertensive patients demonstrated that telmisartan achieved more powerful blood pressure reductions compared with the ACE-inhibitor ramipril.^5,6

�The benefits of telmisartan seen in ONTARGET^� and previous trials may be attributed to the specific pharmacological properties and mode of action of telmisartan, including long half-life, large volume of distribution, high cell penetration and a selective AT1 blockade. ONTARGET^� now provides the evidence that the properties of telmisartan translate into relevant clinical outcomes�, commented Professor Michael B�hm, Director of the Department of Cardiology, Universit�tsklinik des Saarlandes, Homburg, Germany and National Coordinator of the ONTARGET^� Trial in Germany.

Addressing the world�s largest healthcare burden
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

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 editors

About ONTARGET^�

The ONTARGET^� Trial Programme consists of two randomised, double-blind, multicentre international trials: the principle trial, ONTARGET^� which reports its results today, and a parallel trial TRANSCEND^� (Telmisartan Randomized AssessmeNt Study in ACE-i INtolerant subjects with cardiovascular Disease), which is planned to be reported later in the year.³

The treatment arms for the ONTARGET^� Trial were telmisartan 80mg, ramipril 10mg, and combination therapy with telmisartan 80mg and ramipril 10mg. In the TRANSCEND^� trial the treatment arms are telmisartan 80mg or placebo � both on top of standard blood pressure care, not including an ACE or another ARB.³

Patients enrolled in the ONTARGET^� Trial Programme were aged ≥ 55 years, had a history of coronary artery disease, stroke or recent (> 7 days, < I year) transient ischaemic attack, peripheral vascular disease, or diabetes mellitus with target-organ damage such as microalbuminuria, ankle-brachial index < 0.8, or left ventricular hypertrophy.³

The ONTARGET ^� Trial had a four-fold composite endpoint:

cardiovascular death
myocardial infarction
stroke, and
hospitalisation for heart failure.

Patients intolerant to ACEs were not eligible for the ONTARGET ^� study. Intolerance to ACE was a requirement for enrolment into TRANSCEND^�.

About telmisartan (Micardis^�/Kinzal^�/Pritor^�)
Telmisartan is a member of the angiotensin II receptor blocker (ARB) class and approved for the treatment of mild to moderate hypertension. It is being investigated in the most ambitious and far-reaching research programme ever conducted with an ARB. In the ongoing clinical trial programmes ONTARGET^� , PROTECTION^� and PRoFESS^�, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan.

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^� in markets across Europe. Pritor^� and PritorPlus^� is also marketed by GlaxoSmithKline in selected markets.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world�s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment, Prescription Medicines, on research and development. 2007 business figures will be available from 8 April 2008 onwards.

Please note
Micardis^� is registered for the indication mild-moderate hypertension only. While presenting the scientific results of the ONTARGET^� study, Boehringer Ingelheim does not recommend the use of Micardis^� in patients that do not fulfill the criteria of the prescribing information.

Novel oral anticoagulant Pradaxa� (dabigatran etexilate) approved by the European Commission

Thu, 27 Mar 2008 00:00:00 GMT

Ingelheim/Germany, 27 March 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa^� (dabigatran etexilate) in all 27 EU member states. It is anticipated that Pradaxa^� will be launched in Germany and the United Kingdom in the coming weeks.

Pradaxa^� is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.

Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said:
�This first licence for our novel oral anticoagulant Pradaxa^� marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi (blood clots). In addition, we remain confident in the potential for Pradaxa^� to satisfy the unmet medical needs of even more patients and physicians in the future as we continue to invest in our extensive RE-VOLUTION� clinical trial programme investigating Pradaxa^� across four further therapeutic areas.�

Commenting on this milestone in thromboprophylaxis, Dr Bengt Eriksson, MD, PhD, Principal Investigator of RE-NOVATE� and RE-MODEL� studies, Department of Orthopaedic Surgery, University Hospital Sahlgrenska/ �stra, Gothenburg, Sweden said:
�The risk of a potentially life-threatening thrombosis is a major concern following major orthopaedic surgery. For many years, there has been a need for an effective oral anticoagulant with a good safety profile to enable convenient thromboprophylaxis management in and out of the hospital environment. Now, following the approval of Pradaxa^�, we will have an attractive alternative to other thromboprophylaxis regimens to protect our patients from venous thromboembolism (VTE).�

Patients undergoing hip and knee replacement surgery are at particularly high risk of developing VTE.¹ Without thromboprophylaxis, up to 60 percent of orthopaedic surgery patients have been shown to develop DVT (deep vein thrombosis; including asymptomatic thrombi), and 0.2-10 percent are at risk of a potentially fatal PE (pulmonary embolism) according to previous studies.¹ In addition to the acute risk of mortality, VTE is associated with long term risks of recurrent episodes of VTE and eventually post-thrombotic syndrome (chronic venous insufficiency). These complications contribute substantially to patient morbidity and cost of management.²

The risk of VTE in orthopaedic surgery patients extends beyond the usual period of hospitalisation and current guidelines recommend that patients undergoing knee or hip replacement surgery receive thromboprophylaxis such as low molecular weight heparins or vitamin K antagonists for at least 10 days after surgery, extending to 28-35 days for hip replacement surgery.¹ Despite this guidance and the availability of effective thromboprophylaxis options, therapy is often discontinued following discharge due to complexities and inconvenience in administration, although patients are at continued risk.³ As a result, VTE is one of the most common causes of hospital readmission following orthopaedic surgery.⁴

European approval of Pradaxa^� follows the submission of efficacy and safety data in February 2007 from the phase III RE-NOVATE� and RE-MODEL� studies.^5,6 Oral, once daily administration of both 150 and 220 mg Pradaxa^� was demonstrated to be as effective and safe as injectable enoxaparin (40 mg) in preventing VTE and all cause mortality following total hip replacement surgery and total knee replacement surgery in the RE-NOVATE� and RE-MODEL� trials, respectively.^5,6 All test results were evaluated by an independent central adjudication committee blinded to the drug received by any patient.

With all anticoagulant agents it is important to optimize the balance of efficacy and safety. In addition to the critically important bleeding profile, hepatic and cardiac safety need to be considered, as well as tolerability. In both the RE-NOVATE� and RE-MODEL� trials, a low incidence and severity of major bleeding (including those occurring at the surgical site), similar to enoxaparin was reported.^5,6

Patients were frequently monitored and assessed for liver enzyme elevations by an independent data safety monitoring committee. Rates of liver enzyme alanine aminotransferase (ALT) elevations greater than three times the upper limit of normal (3x ULN) were low and comparable to enoxaparin at any time post-baseline with Pradaxa^�, supporting hepatic safety.^5,6

Pradaxa^� displayed a favourable cardiac safety profile; no incidences of adjudicated Acute Coronary Syndrome (ACS) events were reported during 3 months follow up with Pradaxa 220 mg, suggesting no rebound coagulation effect once treatment ends.^5,6 A favourable tolerability profile, comparable to enoxaparin, was also reported following a low number of adverse events leading to treatment discontinuation.^5,6

The standard recommended dosage of Pradaxa^� is a fixed oral dose of 220 mg given once daily. 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. 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.

Pradaxa^� prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme that enables the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore prevents the development of a thrombus.^7,8 Pradaxa^� has a rapid onset and offset of action and predictable anticoagulation effect, avoiding the need for coagulation monitoring.^9,10 It exhibits no drug-food interactions and has a low potential for drug-drug interactions.^11,12

Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa^� in a range of thromboembolic disease conditions. RE-VOLUTION� is an extensive clinical trial programme involving more than 34,000 patients worldwide. Recent progress announcements include the early enrolment completion of 18,114 patients in RE-LY�, the largest atrial fibrillation outcomes trial to date. Other ongoing studies are evaluating the efficacy and safety of Pradaxa^� in the treatment of acute VTE, the secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome.

Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for 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.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world�s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

Click images for download.


Injection to prevent thrombosis after a knee replacement surgery	Dabigatran etexilate preventing venous thromboic events (VTE)

FDA grants fast track designation for Boehringer Ingelheim�s BIBW 2992 for the treatment of late stage non small cell lung cancer (NSCLC)

Thu, 14 Feb 2008 00:00:00 GMT

Ingelheim/Germany, 14. February 2008 � Boehringer Ingelheim�s investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed.

The FDA`s Fast Track Programme will facilitate the development programme and expedite the review of new treatments that demonstrate the potential to address an unmet medical need in serious or life-threatening diseases.

�We are pleased that the FDA acknowledges the therapeutic potential of BIBW 2992 by granting a Fast Track Designation.� stated Dr Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim and responsible for Research, Development and Medicine. �We are confident that the pharmacologic evidence of activity in this indication and data from the clinical development programme will support the use of BIBW 2992 for patients who have hardly any treatment option left�.

If approved Boehringer Ingelheim will market the compound under the trade name TOVOK�.

About the FDA Fast Track Designation
Fast Track is a formal mechanism to interact with the FDA using approaches that are available to all applicants for marketing claims. The Fast Track mechanism is described in the Food and Drug Administration Modernization Act of 1997 (FDAMA). The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world�s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 47 countries and more than 38,000 employees. Since it was founded in 1885, the privately-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.5 billion euro while spending nearly 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.