http://www.boehringer-ingelheim.com RSS newsfeed of Boehringer Ingelheim GmbH in Germany en 2006 - 2008. Boehringer Ingelheim GmbH, Germany. All rights reserved. http://www.boehringer-ingelheim.com/corporate/rss/img/bi_logo.gif http://www.boehringer-ingelheim.com 136 83 120 Wed, 18 Nov 2009 00:00:00 GMT
COPD is a chronic lung disease associated with a high level of mortality. According to the latest World Health Orgainzation (WHO) estimates, 210 million people suffer from COPD and it currently ranks as the fourth leading cause of death. However, the WHO predicts that it will become the third leading cause of death worldwide by 2030.¹ In 2005 COPD was estimated to have killed over 3 million people² – more than HIV/AIDS or lung and breast cancer combined.^1,3 Despite this, COPD remains a scarcely known, under-diagnosed and under-treated disease that demands a changed approach to diagnosis and treatment.⁴ Fewer than half of patients with the condition have a proper diagnosis and only 35% of patients receive a regular prescribed medication.^5,6

These issues, among others, have been highlighted by EFA who collected European data for the first time from patient groups` perspectives and are now calling for more to be done to reduce the burden of COPD and improve patient care. Over 11 million Europeans are affected by COPD and face its debilitating consequences on a daily basis.⁷

EFA`s book recognises that even in its early stages, COPD has a devastating impact on patients` quality of life as it begins to damage the lungs irreversibly causing sufferers to struggle for breath and with simple daily tasks.⁸ In addition, patients are frustrated about the difficulty in gaining effective management of their condition including early diagnosis, education, support services and access to the best treatments available. The goal of EFA`s efforts in the coming months will be to reduce the impact of COPD on patients and their caregivers and to focus efforts on a call to action for real improvements.

BI and GSK, who sponsored the project, support EFA`s conclusion that there is an urgent need for a coordinated strategy of advocacy both at European and national level. To improve overall COPD management, the following four areas of focus were identified:

• Increase the awareness of the public at large about COPD, its symptoms and risk factors in order to prevent the disease and to encourage sufferers to seek early diagnosis
• Raise the priority of COPD with policy makers to encourage the creation of screening guidelines and mandates for early diagnosis and management of the disease
• Improve the access to care and management for diagnosed COPD patients
• Safeguard the respiratory health of future generations.

Notes to Editors
The development and publication of the EFA Book on COPD in Europe: Sharing and Caring has been funded by an educational grant from Boehringer Ingelheim and GlaxoSmithKline. It aims to: Inform policy makers (EU and national) about COPD thereby prompting action where necessary Encourage healthcare professionals to collaborate with patient organisations to increase diagnosis, assessment and treatment of COPD patients Raise the awareness and prioritisation of this disabling disease.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world`s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

GlaxoSmithKline – one of the world`s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7115 Mon, 16 Nov 2009 00:00:00 GMT1 Flibanserin is an investigational compound that is being developed by Boehringer Ingelheim for the treatment of pre-menopausal women with HSDD.

HSDD is a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties. Women with HSDD often feel a loss of intimacy and closeness that they used to enjoy. The condition can negatively impact a woman`s life and her relationship with her partner.^2,3,4,5

The complete flibanserin pivotal trial programme was presented today at the 12th Congress of the European Society for Sexual Medicine in Lyon, France. It included an analysis of three pivotal Phase III North American trials (DAISY, VIOLET and DAHLIA) and the pivotal Phase III European data (ORCHID). In addition results from a pooled analysis of two pivotal Phase III North American trials (DAISY and VIOLET) and a pooled analysis of the North American and European data (DAISY, VIOLET and ORCHID) were presented, assessing the safety and efficacy of flibanserin 100mg in pre-menopausal women suffering with HSDD.

"Despite studies demonstrating that HSDD is a common form of female sexual dysfunction, there is currently no approved prescription treatment for pre-menopausal women suffering from the condition" said Professor Rossella Nappi, director of the Gynaecological Endocrinology & Menopause Unit at the Maugeri Foundation, University of Pavia, Italy, and primary investigator of the European pivotal trial. "Flibanserin is a novel, non-hormonal compound, that has been investigated as a treatment for pre-menopausal women with HSDD. Based on the clinical trial results presented at ESSM it has the potential to help many women suffering from their lack of sexual desire."

Pooled North American Phase III Trial Results (DAISY and VIOLET)⁶
The pre-specified pooled analysis of 1,378 pre-menopausal women with HSDD shows a statistically significant increase in the frequency of SSEs per month in women taking flibanserin 100mg (from 2.8 at baseline to 4.5), versus placebo (2.7 at baseline increasing to 3.7) over the 24-week study period. Flibanserin also demonstrated statistically significant improvements in sexual desire versus placebo as measured by an electronic diary (the eDiary For HSDD Trials). This finding was further supported by data from the desire domain of the Female Sexual Function Index (FSFI) as an independent secondary measure.

Other key secondary endpoints showed flibanserin significantly improved sexual functioning (as measured by the FSFI total score), distress related to sexual dysfunction (as measured by the Female Sexual Distress Scale-Revised, FSDS-R, score) and distress related to low sexual desire (FSDS-R Item 13 score) versus placebo.

European Phase III Trial Results (ORCHID) ⁷
The analysis of 634 pre-menopausal women with HSDD showed women taking flibanserin 100mg had statistically significant improvements in their level of sexual desire, as measured by the eDiary. These findings were supported by a trend towards an increase in the FSFI desire domain. In addition there was a statistically significant improvement in the level of distress associated with sexual dysfunction (as measured by the FSDS-R total score) as well as distress related to low sexual desire (FSDS-R Item 13) which is the second key parameter for the diagnosis of HSDD. A numerical increase in the number of SSEs compared to placebo supports the efficacy of flibanserin in pre-menopausal women suffering with HSDD.

North American and European Phase III Trial Results - Pooled Analysis (DAISY, VIOLET and ORCHID)¹
A pooled analysis of pivotal data including the European study (ORCHID) and the American Phase III trials (DAISY and VIOLET) reinforces the efficacy of 100mg flibanserin for the treatment of pre-menopausal women with HSDD. Results show a statistically significant improvement versus placebo in the number of SSEs, as well as a statistically significant increase in the level of sexual desire, recorded via the eDiary and the FSFI desire domain scores. Distress associated with sexual dysfunction and specifically low sexual desire was significantly reduced with flibanserin 100mg (as measured by FSDS-R score and FSDS-R Item 13 score).

Safety Analysis⁸
Most adverse drug reactions with flibanserin 100mg were mild to moderate, emerged during the first 14 days of treatment and resolved with continued treatment. The most common adverse events (AEs) reported by more women on flibanserin than on placebo included dizziness, nausea, fatigue, somnolence and insomnia. The findings are consistent across the North American and European trials with about 14% and 16% of women on flibanserin 100mg and 8% and 5% of women on placebo discontinuing treatment due to AEs in the respective trials.

"Findings from the pivotal Phase III trials show that flibanserin 100mg is effective and well-tolerated for the treatment of Hypoactive Sexual Desire Disorder in pre-menopausal women," said Elaine Jolly, Medical director, Shirley E. Greenberg Women`s Health Centre of the Ottawa Hospital and Professor of Obstetrics and Gynecology, University of Ottawa, and one of the Canadian physicians participating in the Phase III trials. "Flibanserin acts as an agonist at the serotonin 5-HT1A receptor and as an antagonist at the 5HT2A receptor with preferential affinity to selective brain areas. It is believed to act on neurotransmitters within the brain that are thought to play a role in sexual response. By modulating these neurotransmitter systems, flibanserin may help to restore a balance between inhibitory and excitatory factors leading to a healthy sexual response."

Notes to Editors:
About the Pivotal Phase III Trials - Inclusion criteria, endpoints and scales
The North American and European trials were designed to study flibanserin for 24-weeks in a randomised, placebo-controlled setting and involved women with generalised acquired HSDD who were treated with flibanserin 100mg (found to be the most consistently effective dose in the individual trials) or placebo. All the women in the studies were in stable, communicative, monogamous, heterosexual relationships for at least one year and were required to use a reliable form of contraception.

In the North American pivotal trials, the co-primary endpoints were changes from four-week baseline period to week 21 to 24 in the number of SSEs and sexual desire score as recorded daily by patients using an electronic diary (the eDiary For HSDD Trials). Both are patient reported outcome measures. In the European pivotal trial the primary endpoint was changes from baseline compared to week 24 in the number of SSEs, which were also recorded daily using the eDiary.

SSE measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether the event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful), irrespective of whether women had an orgasm or whether the event was satisfying for the partner. This definition of an endpoint was based on a draft guidance document issued by the U.S. Food and Drug Administration (FDA) in 2000.⁹

Boehringer Ingelheim designed the eDiary For HSDD Trials to meet the FDA`s recommendation of measuring levels of desire on a daily basis, and to report the number of satisfying sexual events. The FSFI desire score - an independently developed and validated tool - was included as a secondary endpoint to provide an additional measurement of changes in sexual desire over a longer recall period. The tool, which has a specific desire domain, assesses both the intensity and the frequency of desire over a 4-week period. The FSDS-R is a 13-item questionnaire designed to assess and quantify the change in personal distress associated with female sexual dysfunction. All measures in the trial have undergone rigorous testing to ensure they are valid and reliable.

About Hypoactive Sexual Desire Disorder
HSDD is a form of Female Sexual Dysfunction (FSD). As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity marked by distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications) or a general medical condition. Generalised, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.² Low sexual desire with associated distress is the most commonly reported female sexual complaint. In prevalence studies¹⁰ approximately 1 in 10 women reported low sexual desire with associated distress, which may be HSDD. Sexual Desire Disorders are generally under-diagnosed and there are currently no pharmacological treatments available for pre-menopausal women with HSDD. HSDD has been recognised as a medical condition for over 25 years.

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 with the USA.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7095 Mon, 02 Nov 2009 00:00:00 GMT® technology platform. A record productivity of more than 100 picogramms per cell per day was achieved in inoculum and fed-batch cultures of BI-HEX^® Chinese hamster ovary (CHO) cell lines expressing a therapeutic monoclonal antibody.

At this point the most recent result coming out from the BI-HEX^® platform suggests that another leap in productivity is indeed possible. Combining sophisticated vector set-ups with rigorous high-throughput screenings enabling rapid selection of high-producer cell lines under process conditions and the latest version of a Boehringer Ingelheim proprietary media and feed platform led to the generation of cell lines that produce previously unreported amounts of an IgG molecule during inoculum culture and in a scalable fed-batch format.


Boehringer Ingelheim is one of the worlds leading manufacturers for producing therapeutic proteins from mammalian cell culture. As a true one-stop-shop (from the genetic engineering up to the launch of a biopharmaceutical) Boehringer Ingelheims biotechnology site in Biberach/Riss (Germany) offers more than 100.000 liters of GMP cell culture capacity, more than 20 years of process and regulatory experience and its BI-HEX^® CHO platform shaping the state-of-the-art of the industry for many years.

The success of therapeutic antibodies produced from mammalian cell culture in the clinic and on the market has fuelled a race to increase cellular productivities for many years with scientists all over the world asking at what point fundamental limits would be reached.

"We are enthusiastic about the new proof that our BI-HEX^® technology platform continues to revolutionize the biopharma landscape leading to antibody productivities in industrial relevant CHO processes beyond that magic boundary of 100 picogramms per cell per day," states Professor Rolf Werner, Senior Vice President of the Corporate Division Biopharmaceuticals at Boehringer Ingelheim.

"We are particularly encouraged by this result, as we obtained the data without any cell-line specific process optimization", adds Dr. Lore Florin who is leading a team of scientists reporting the new record productivities.

Boehringer Ingelheim will continue to develop BI-HEX^® and expects further improvements to be reported in the near future.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7075 Thu, 29 Oct 2009 00:00:00 GMT
Professor Ley’s innovative research comprises the total syntheses of more than 120 compounds -mostly of specific biological activity- and covers a wide field of organic chemistry. An important project of his is the synthesis of five members of the Thapsigargin family. These molecules are even in low concentrations excellent inhibitors of the calcium pump of cellular organelles¹ and serve as probes in the study of intracellular information paths all over the world.

Recently, Professor Ley concluded the synthesis of the marine natural products Bengazole A and B, a new class of lipophilic molecules, which possess antifungal activity. The recent synthesis of the insect-antagonising natural product Azadirachtine caused attention and was the final result of 22 years of research. Ley’s synthesis of the immunosuppressive and tumor-antagonising compound Rapamycine contributed to his worldwide reputation.

In addition to these methods, designed for the synthesis of natural products, Professor Ley developed numerous techniques for the production of pharmaceutical lead structures. His contributions to the green chemistry, which reduces or eliminates the use and generation of hazardous substances impress just as much. Worldwide Steven V. Ley is known as pioneer in the development of automatised synthesis and leading in this area of research. He developed micro- and macro-flow reactors, which are essential for and therefore revolutionised multi-step chemical syntheses.

Prof. Leys methods are broadly used in the pharmaceutical industry to speed up the development of new lead structures. As a result medications are sooner available for patients. Steven V. Ley’s versatile chemistry and its importance for industry and science make him one of the most excellent chemists of our time.

The Heinrich Wieland Prize is named after the German Nobel Laureate Prof. Heinrich Otto Wieland (1877-1957). Heinrich Wieland was a cousin of Helene Boehringer, the wife of Albert Boehringer, who was the founder of Boehringer Ingelheim. From 1915 to the end of 1920, he was advisor at Boehringer Ingelheim and during this time he established the first scientific department of the company. The prize is one of the most treasured international science awards in Germany. Its special importance is reflected by the list of former laureates, which includes many famous scientists. Michael S. Brown and Joseph L. Goldstein of Dallas/Texas (USA), rewarded the Heinrich Wieland Prize in 1974, have been awarded the Nobel Prize for medicine in 1985. To date it has been presented to 59 scientists. The Heinrich Wieland Prize is sponsored by Boehringer Ingelheim and awarded by an independent Board of Trustees.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 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.

¹The sarco/endoplasmatic reticulum
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7055 Mon, 26 Oct 2009 00:00:00 GMT
"Boehringer Ingelheim and Fort Dodge share a strong commitment to innovation and this will continue to be the imperative basis of all our activities as we move forward," said Hubertus von Baumbach, Member of the Board of Managing Directors of Boehringer Ingelheim responsible for Finance and Animal Health. "With the closing of this deal, our attention now turns to ensuring a seamless integration of the highly committed teams of people as well as the transition of the product portfolio. We aim to jointly execute a robust business strategy that ensures the continued growth of our animal health business in the U.S. and globally by continuously providing innovation to our customers."

As part of the deal, Boehringer Ingelheim will acquire the Duramune^® line of vaccines for dogs, the Fel-O-Vax^® line of vaccines for cats, and the Rabvac^® line of rabies vaccines manufactured and sold in the U.S., Canada and Australia. In addition, a portfolio of pet and equine pharmaceutical products currently sold in the U.S. is also included in the deal. The company will also acquire cattle vaccines in the U.S. and Canada including the Triangle^®, Pyramid^®, and Presponse^® vaccine lines. Pharmaceutical products being acquired include Cydectin^® (moxidectin) for cattle and sheep as well as Polyflex^® (ampicillin sodium). The dairy portfolio includes the key brands Today^® and Tomorrow^®. Several Canadian swine vaccines are included in the acquisition as are some cattle vaccines sold in Europe and South Africa.

"The products included in this acquisition complement our already strong product lines and help to broaden our innovation base across more species and boost our global pipeline," said Prof. Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim. "We look forward to applying our innovative culture to the products included in this acquisition as well as to the research and discovery of new products that will continue to bring value to our customers and our business."

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro (US $17 billion) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7035 Fri, 23 Oct 2009 00:00:00 GMT® (telmisartan) for the reduction of cardiovascular morbidity in patients with:
I. manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
II. type 2 diabetes mellitus with documented target organ damage.

The CHMP opinion follows a review of clinical trial results including The ONTARGET Trial involving 25,620 patients and confirmed Micardis^® as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk.¹ The results also demonstrated that Micardis^® is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.^1-2

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, We are delighted to receive this positive opinion from the CHMP. This is an important development that will help physicians ensure that patients receive appropriate treatment tailored to their individual needs. If approved, Micardis^® will offer a much needed alternative to ACE inhibitors in the treatment of patients with high CV risk.

Earlier this week, the US Food and Drug Administration (FDA) approved Micardis^® for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors.

• Cardiovascular disease is responsible for nearly one in three deaths worldwide and is the number one cause of death³
• CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%).4 About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke⁵
• 15 million people each year suffer strokes and 5 million are left permanently disabled⁶

Micardis^® is one of the most studied antihypertensives in clinical trials and is widely used with over five million patient years since its approval. Its safety profile is similar to that of placebo.

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 USA.

About telmisartan (Micardis^®/Kinzal^®/Pritor^®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and was 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 were enrolled to investigate the efficacy and 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 Schering Pharma in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis^®, Bayer Schering Pharma 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^® are also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET™ Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer Schering Pharma and GlaxoSmithKline.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7015 Mon, 19 Oct 2009 00:00:00 GMTMicardis^® is now indicated for cardiovascular (CV) risk reduction in patients with intolerance to angiotensin-converting enzyme (ACE) inhibitors.

• Boehringer Ingelheim`s Micardis^® (telmisartan) is the ONLY treatment in its class approved by the U.S. Food and Drug Administration (FDA) in patients at high CV risk who are unable to take ACE inhibitors
• Micardis^® is the first indicated treatment option in its class to prevent serious CV events in patients at high CV risk who are unable to take ACE inhibitors
• This new indication is based on The ONTARGET Trial results which showed that Micardis^® may prevent one in five serious CV events or death from cardiac causes.

Ingelheim, Germany, 19 October 2009 - Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for Micardis^® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. Micardis^® is the first treatment in its class to be approved for this indication.

The FDA approval is based upon clinical trial results from The ONTARGET Trial involving 25,620 patients and confirmed Micardis^® as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk. The results also demonstrated that Micardis^® is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.^1-2

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, "We are delighted with this new indication for Micardis^®, which will provide both physicians and their patients who are at risk of cardiovascular events with a much needed alternative to ACE inhibitors. Approximately one in four patients is unable to tolerate an ACE inhibitor. Now, these patients can be confident that with Micardis^®, they have a proven, effective and well tolerated option to reduce their risk of severe CV events."

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) is currently reviewing a similar submission for Micardis^® in Europe. The recommendation from the CHMP is expected in November.

• Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death³
• Every year, nearly 900,000 Americans die from CVD. This is equivalent to around 2,300 deaths every day or two every minute⁴
• 80 million Americans currently suffer from one or more forms of CVD4 more than the total population of France⁵
• CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%).⁶ About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke.⁷

Micardis^® is one of the most studied antihypertensives in clinical trials and is widely used with over five million patient years since its approval. Its safety profile is similar to that of placebo.

Notes to the 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 USA.

About telmisartan (Micardis^®/Kinzal^®/Pritor^®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and was 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 were enrolled to investigate the efficacy and 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 Schering Pharma in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis^®, Bayer Schering Pharma 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^® are also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET™ Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer Schering Pharma and GlaxoSmithKline.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=6977 Mon, 19 Oct 2009 00:00:00 GMT

• Twynsta^® delivers very powerful blood pressure (BP) reductions of up to 40/29 mmHg¹ and a 24-hour BP response rate of up to 98%² for hypertensive patients at risk of cardiovascular (CV) events
• Twynsta^® combines the proven evidence base in CV outcomes of telmisartan and amlodipine^3-9in a convenient single pill
• Twynsta^® achieves superior BP reductions compared to amlodipine 10mg and is significantly better tolerated with 71% less peripheral oedema.¹⁰

Ingelheim/Germany, 19 October 2009 - Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved Twynsta^®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). Twynsta^® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

This new combination benefits from the complementary modes of action of long-lasting angiotensin receptor- and calcium channel-blockade. This provides powerful efficacy in 24-hour BP reduction and control^10-17and combines it with the proven evidence base in cardiovascular (CV) outcomes^3-9 of both telmisartan and amlodipine. Telmisartan is the only ARB with proven evidence to reduce CV death, myocardial infarction (heart attack) and stroke beyond the effect of BP reduction in a wide range of patients at risk of CV events.^3-4 In the US, it is the only ARB indicated for CV risk reduction in patients who are unable to take ACE-inhibitors.¹⁸

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy said, In hypertensive patients, treatment tolerance and compliance are significant issues. The data for this combination of telmisartan and amlodipine show that it is effective and well tolerated in a range of more complex, difficult-to-treat patients as well as in those whose BP was previously not controlled on monotherapy. This combination provides a valuable and important new option for patients and physicians, particularly as it includes two components, telmisartan and amlodipine, each with clinically proven CV protection in patients at CV-risk.

The FDA approval of Twynsta^® is based on the results of one placebo-controlled and two active-controlled trials involving a total of 3,505 patients with stage 1 or stage 2 hypertension.^*20-21These trials demonstrated that Twynsta^® provided powerful BP lowering that was sustained for at least 24-hours, and was also effective and well-tolerated in hypertensive patients at risk of CV events, including patients with Type 2 diabetes, elderly and obese patients.

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, We are delighted with the approval of Twynsta^® and believe that, with its excellent safety profile and demonstrated efficacy, Twynsta^® will help physicians and patients to overcome common barriers to effective blood pressure control, such as treatment adherence.

Twynsta^® will be available in the US from November 2009 in a flexible range of dosing regimens (40/5mg, 40/10mg, 80/5mg, 80/10mg) enabling physicians to tailor treatment to individual patient needs.

Twynsta^® has recently also been submitted for approval in Europe and Japan, and is on schedule to be submitted in other countries around the world. Boehringer Ingelheim is committed to make this valuable new therapeutic option available to patients and health care providers as soon as possible after Marketing Authorisation approval is obtained.

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 has been 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 were enrolled to investigate the efficacy and 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.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

^* Stage 1 hypertension, SBP mmHG 140-59 or DBP mmHG 90-99; Stage 2 hypertension SBP mmHG >160 or DBP >100¹⁹


References:
1 Data on file, Boehringer Ingelheim.
2 Littlejohn TW III et al. Telmisartan and amlodipine combination therapy is powerful at lowering 24-hour blood pressure: Findings of an ambulatory blood pressure monitoring substudy in hypertensive patients. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
3 The ONTARGET™ Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. New England Journal of Medicine 2008; 358(15):1547-59.
4 The TRANSCEND Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial. Lancet Published online 31 August 2008.
5 Pitt B et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation 2000;102(13):150310.
6 Nissen SE, et al. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial.JAMA 2004;292(18):221725.
7 Dahlof B, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005;366(9489):895906.
8 Williams B, et al. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation 2006;113(9):1213 25.
9 Leenen FH, et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial.Hypertension 2006;48(3):37484.
10 Littlejohn T III et al. Results of treatment with telmisartan-amlodipine in hypertensive patients. J Clin Hypertens (Greenwich) 2009;11:207213.
11 Littlejohn T III et al. Telmisartan plus amlodipine in patients with moderate or severe hypertension: results from a subgroup analysis of a randomized, placebo-controlled, parallel-group, 4 x 4 factorial study. Postgrad Med 2009;121(2):514.
12 Littlejohn T, et al. Combination of telmisartan with amlodipine provides an effective treatment option for elderly patients: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
13 Littlejohn T, et al. Telmisartan in combination with amlodipine provides highly effective and well tolerated treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
14 Littlejohn T, et al. Efficacy of telmisartan in combination with amlodipine in obese hypertensive patients: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
15 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in Black and Latin American hypertensive patients: finding of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
16 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in diabetic and obese hypertensive patients: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
17 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in elderly hypertensive patients and those with elevated SBP: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
18 MICARDIS (telmisartan) US Label / Summary of Product Characteristics
19 Seventh The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7full.htm, accessed on 16th October 2009
20 Neldem S, et al. Fixed-dose combination therapy with telmisartan and amlodipine 5 mg in non-responders to amlodipine 5 mg provides superior blood pressure reductions to, and is better tolerated than, amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
21 Neldam S, et al. Switch to a fixed-dose combination therapy with telmisartan and amlodipine provides significant blood pressure reduction and control in patients not adequately controlled with amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=6996 Wed, 14 Oct 2009 00:00:00 GMT®/Sifrol^® (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorisation by the European Commission in all EU/EEA^*) countries for the treatment of early and advanced idiopathic Parkinson`s disease (PD). The approval was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate release tablet taken three times daily.^1-6

In addition to clinical trial results that confirm the important therapeutic benefits of the new formulation when administered in a convenient once-a-day regimen, a further trial has shown that patients already taking Mirapexin^®/Sifrol^® immediate release tablets may easily be switched overnight to the Mirapexin^®/Sifrol^® prolonged-release tablet, at the same daily dose.^7,8

"The European approval of the new formulation marks another big step in meeting patients` needs and represents a milestone for this worldwide highly successful treatment for Parkinson`s disease. We are very pleased that due to the robust evidence base, the regulatory review experienced no delay, which will allow the first European countries to already make the once daily tablet available to patients," said Dr. Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim Corporate Headquarters. "In addition, the data show that the prolonged-release Mirapexin^®/Sifrol^® tablet causes less frequent fluctuations in the plasma concentration over 24 hours compared to the three times daily administration of the immediate release tablet, an important aspect for physicians when choosing the best treatment option for their patient."

Mary Baker, MBE, President of the European Federation of Neurological Associations (EFNA) commented on the European approval of the new formulation: "Most people with Parkinson`s disease take many different pills on a daily basis, to manage their PD symptoms and other concomitant conditions. Being able to reduce their pill burden without foregoing the effectiveness will be welcomed by patients as well as by their care givers as it is expected that a once-daily administration can improve patient adherence to their treatment regimen."

A new drug application (NDA) for a once daily, extended release formulation of pramipexole (marketed under the trade name Mirapex in the U.S.A.) is in review with the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson`s disease (currently available in the U.S.A. as immediate release formulation).

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 Parkinson`s disease (PD)
Parkinson`s disease 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.^9-13 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. Symptoms can vary from patient to patient, but worsen over time.

About Mirapexin^®/Sifrol^® (pramipexole)
Pramipexole (known under the trade names Mirapexin^®, Sifrol^®, Mirapex and Pexola) is a compound from Boehringer Ingelheim research first approved in 1997 and to date available in over 70 countries across the globe for the treatment of the signs and symptoms of early and advanced idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. In October 2009, pramipexole received approval by the European Commission for its new prolonged-release, once daily tablet for the treatment of early and advanced Parkinson`s disease. Pramipexole (immediate release formulation) is also indicated since 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS).

The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson`s disease treated with pramipexole were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.

Pramipexole may cause patients, particularly with Parkinson`s disease, 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.

Patients and caregivers should be aware of the fact that abnormal behaviour (reflecting symptoms of impulse control disorders and compulsive behaviours) such as binge eating, compulsive shopping, hypersexuality and pathological gambling have been reported in patients treated with dopaminergic drugs, including pramipexole. Dose reduction/tapered discontinuation should be considered.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world`s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

^*all 27 Member States of the European Union plus Norway and Iceland
]]>http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=6795 Wed, 07 Oct 2009 00:00:00 GMT
The non-assert declaration means that the company will not enforce its patent rights against the agreement partner. The company has further waived the provision of a nominal royalty fee under the access policy so the partnering companies can supply the nevirapine-containing drugs without any payments to Boehringer Ingelheim. This goes far beyond the conditions of the patent pool currently under discussion. Generic manufacturers whose nevirapine product and production site have been pre-qualified by WHO are enabled to supply in total 78 countries which are either Least Developed Countries (LDC) according to the UNDP classification, or low income countries according to the World Bank classification and all other countries in Africa. The drugs can be produced in any country for supply of the these 78 countries on the combined list. Another important aspect is that by providing only WHO pre-qualified generic producers with the non-assert declaration the quality of nevirapine is guaranteed. This is crucial in countries with weak or non-existent Drug Regulatory Authorities and is in line with our Corporate Responsibility. This policy has been praised in particular by patient interest organisations from resource-limited countries affected by low-quality products.

Being aware of our responsibility and actively striving for the idea of a pool Boehringer Ingelheim welcome the UNITAIDs initiative. We have been in constructive discussions with the promoters of the pool idea for some time and we will carefully observe future developments. For now we are certain that our approach as promoted for instance also by academic institutions is the better option. We have committed ourselves in our publicly available HIV Policy to also apply this approach to our other anti-retroviral medication tipranavir. We are exploring options how best to collaborate with potential generic producers.

Additional information:
In the past Boehringer Ingelheim granted Voluntary Licenses to several companies in Africa enabling them to produce generic nevirapine for low income countries as per World Bank classification. In order to further improve and facilitate access to nevirapine, Boehringer Ingelheim will not enforce its patents and offers interested manufactures listed on the WHO prequalification list non-assert declarations allowing them to supply nevirapine-containing medicines for Eligible Countries. These Eligible Countries are defined as all low income countries according to the World Bank classification of economies, all countries classified as Least Developed Country (LDC) according to the United Nations and all African states which are not classified as low income of LDC like South Africa, Botswana.
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