The advisory committee also voted affirmatively that data from the UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) trial adequately addressed the potential safety concern for an increased risk of stroke (11 yes to 1 no) or adverse cardiovascular events (11 yes with 1 abstention).  This is consistent with the current product label.  The advisory committee makes recommendations to the FDA, which the agency considers in its final decision.

“We are pleased with the advisory committee’s vote today supporting the claim that SPIRIVA HandiHaler reduces COPD exacerbations,” said Christopher Corsico, M.D., MPH, Vice President, Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.  “Exacerbations in COPD patients may lead to disability, premature death and increased healthcare costs.  We look forward to working with the FDA during the final stages of its review of our sNDA.”

The advisory committee reviewed pivotal data from a six-month trial (Veterans Affairs Study, 205.266) of 1,829 COPD patients and secondary endpoints from a four-year trial (UPLIFT Study, 205.235) of approximately 6,000 COPD patients.  Although UPLIFT did not meet its primary endpoint, the study supports data from the VA trial showing that SPIRIVA HandiHaler consistently reduced the risk of exacerbations in COPD patients.  COPD exacerbations were defined as patients having a new onset or worsening of symptoms (including cough, sputum, wheezing, or difficulty breathing) lasting for at least three days and which require a change in treatment (antibiotics or steroids), which could include hospitalization.

The safety profile of SPIRIVA HandiHaler has been well-established in clinical studies involving more than 17,000 COPD patients, 11,000 of whom were treated with SPIRIVA HandiHaler, and in post-marketing experience involving more than 16 million patient-years of exposure since its European approval in 2002.  SPIRIVA HandiHaler was approved in the U.S. in 2004.

About COPD
COPD is a progressive, but preventable and treatable lung condition that is characterized by a restricted flow of air into and out of the lungs and loss of lung function over time.  It includes chronic bronchitis, emphysema, or both.

COPD is the fourth-leading cause of death and the second-leading cause of disability in the United States, and is projected to become the third-leading fatal illness by 2020. Each year, COPD kills 120,000 Americans – that’s one death every four minutes.

The disease primarily affects current and former smokers and symptoms include shortness of breath, coughing (sometimes with phlegm or mucus) and wheezing.  COPD makes it difficult to breathe and, over time, interferes with a person’s ability to perform daily physical activities.  When most severe, COPD may even limit a person’s ability to perform simple tasks such as washing and dressing.  The damage in the lungs caused by COPD is not reversible, but it is treatable.    

About SPIRIVA® HandiHaler®
SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD). COPD includes chronic bronchitis, emphysema, or both. SPIRIVA relaxes airways and helps keep them open, to help make it easier to breathe when used every day.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. Only use SPIRIVA capsules with the HandiHaler device. The contents of the capsule should only be inhaled by mouth using the HandiHaler device.

Stop taking SPIRIVA and get medical help right away if your breathing suddenly worsens, your throat or tongue swells, you get hives, or have vision changes or eye pain.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not get SPIRIVA powder in your eyes.

Do not use SPIRIVA if you are allergic to any of the ingredients in SPIRIVA capsules (tiotropium, lactose monohydrate) and if you have had any allergic reaction to atropine or any medicines like it, such as ipratropium (Atrovent).

For full prescribing information, please visit www.spiriva.com.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life.  We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals.  Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products.  Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.  For more than 150 years, Pfizer has worked to make a difference for all who rely on us.  To learn more about our commitments, please visit us at www.pfizer.com.

The findings, presented at the 12th Congress of the European Society for Sexual Medicine in Lyon, France, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY® and VIOLET®) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD. 

“HSDD is a complex condition that can cause distress and negatively impact a woman’s self-esteem,” said Anita Clayton, MD, one of the lead study authors and professor of psychiatry and neurobehavioral sciences, University of Virginia.  “With this data, we are making exciting progress in women’s sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women.  This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment.”

North American Phase III Trial Results
In the pooled analysis of 1,378 pre-menopausal women with HSDD, the frequency of SSE increased significantly in women taking flibanserin 100mg (increasing from 2.8 at baseline to 4.5 at study end) versus placebo (2.7 at baseline increasing to 3.7 at study end) over the 24-week study period.  Flibanserin also demonstrated statistically significant improvements in sexual desire versus placebo as measured by a daily electronic diary (eDiary) and the Female Sexual Function Index (FSFI) desire domain.

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 (the score on FSDS-R question 13) versus placebo, which were secondary endpoints.

The most commonly reported adverse events (AEs) with flibanserin 100mg were mild to moderate and emerged during the first 14 days of treatment.  These AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia.  The majority of these AEs resolved with continued treatment.  About 15 percent of women on flibanserin 100mg and seven percent of women on placebo discontinued treatment due to AEs. 

“Sexual desire disorders can affect women of all ages, at any stage of life,” said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.  “Boehringer Ingelheim is pleased to present this data, which provides valuable scientific knowledge about HSDD.”

About the North American Phase III Trial
The North American Phase III clinical trial studied flibanserin at 25, 50 and 100mg doses. The pre-specified pooled analysis included data from two 24-week randomized, placebo-controlled North American trials.  The analysis involved women with generalized, acquired HSDD who were treated with flibanserin 100mg or placebo.  Flibanserin 100mg increased the number of SSE and sexual desire and decreased distress associated with HSDD.  The women in the study were in stable, communicative, monogamous, heterosexual relationships with a sexually-functional partner for at least one year and were required to use a reliable form of contraception.  About 40 percent of women were on some form of hormonal contraception. 

In the North American pivotal trials, the co-primary endpoints were changes from a four-week baseline period to week 21 to 24 in sexual desire score and in the number of SSE, as recorded daily by patients using an electronic diary (eDiary For HSDD Trials).  Both are patient reported outcome measures.  SSE measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether each event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful).     

The FSFI and FSDS-R desire scores - independently developed and validated tools - were included as secondary endpoints to provide additional measurement of changes in desire over a four-week recall period.  The FSFI is a 19-item self-administered questionnaire composed of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain).  The FSDS-R is a 13-item self-administered questionnaire.  The total score ranges from zero to 52, with the higher scores indicating more sexual distress.  Additionally, Boehringer Ingelheim designed the eDiary For HSDD Trials to measure levels of desire on a daily basis.     

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, HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked 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 or psychiatric condition.  Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.  Sexual Desire Disorders are generally under-diagnosed.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Making Sense of Diabetes encouraged people living with diabetes to visually reveal its impact on their lives through one of the five senses:  sight, hearing, taste, touch or smell.   The videos submitted took various approaches ranging from hopeful to dramatic, inspirational and funny.  

One winning video about the sense of sight offered a view of how most people see a bowl of candy -- colorful and sweet.  But when the filmmaker sees candy, he sees a pile of insulin syringes.  Another videographer used the sense of smell to show how diabetes “stinks” because figuring out what to eat is like doing math problems. Other videos revealed feelings of frustration, anger, hope and triumph through the various senses.

“The creativity and reality captured through this video contest embody the spirit of World Diabetes Day,” said Manny Hernandez, president of the Diabetes Hands Foundation, who has been living with diabetes since 2002. “There are no better ambassadors to communicate the experience of living with diabetes and raise awareness of the condition than those living with it themselves."

The online diabetes community, including bloggers and those within social networks, was extremely enthusiastic about the contest. Video submissions were viewed thousands of times by people around the world, and many viewers posted comments in support of the videos and the people who made them. The resulting compilation video is intended to raise awareness about what it feels like to live every single day with diabetes.

“The online community is an important source of inspiration for anyone living with diabetes,” said Terry Keelan, one of the contest winners. “I’m glad to have had the opportunity to share my perspective and hope my videos will offer encouragement, hope and humor to others living with diabetes.”

• Dennis Adair, PA
• Fabiana Couto, Sao Paulo, Brazil
• Patricia Harmon, NJ
• Scott Johnson, MN
• Andrew Jones,  CA
• Terry Keelan, CA
• Joseph Nielsen, TX
• George Simmons, CA
• Bill Woods, CT
• Lorraine, CT

About Diabetes
Approximately 23.6 ¹ million Americans and 246 million people worldwide² have diabetes. Type 2 diabetes is the most common type, accounting for more than 90% of all diabetes cases in the developed world.³ Each year, more than 200,000 people in North America² and more than 3.8 million people worldwide die from diabetes and its complications² – a number which is expected to increase by more than 50 percent over the next decade.³ Diabetes is a chronic disease that occurs when the body either does not properly produce or use the hormone, insulin.²

About Boehringer Ingelheim and Diabetes
In June 2009, Boehringer Ingelheim announced its pipeline of oral antidiabetic compounds, establishing itself in the type 2 diabetes therapeutic area.  The Company is investigating compounds in Phase II and Phase III clinical development worldwide.

About The Diabetes Hands Foundation
The Diabetes Hands Foundation is a 501(c)(3) nonprofit dedicated to connecting people touched by diabetes (those with diabetes as well as their loved ones) and raising diabetes awareness.

The roots of DHF go back to 2006, when the idea of creating a social network for a higher purpose was born, later turning into TuDiabetes.com®. EsTuDiabetes.com (a sister community in Spanish) followed, along with the Foundation’s first diabetes awareness program, Word In Your Hand™, which was born within the community.

TuDiabetes.com® started in March 2007 and EsTuDiabetes.com was launched in August 2007. With more than 16,000 combined members, both social networks have become top destinations for people searching for support and information about diabetes.

In March 2009, ChangeDiabetesNow.org was started to showcase educational materials created by diabetes community members while serving as an outlet for creative expression and raising diabetes awareness.  All of the awareness programs of the Diabetes Hands Foundation can be found on this web site.

For more information, please visit www.diabeteshandsfoundation.org.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Ingelheim, Germany and St. Joseph, MO, October 26, 2009 - Boehringer Ingelheim, a global pharmaceutical group of companies, together with its U.S. animal health business Boehringer Ingelheim Vetmedica, Inc., announced today that it has closed its deal with Pfizer to acquire a significant portion of the Fort Dodge Animal Health business.  The acquisition, which includes more than 200 products globally, as well as two manufacturing and research facilities located in Fort Dodge, Iowa, significantly increases the size of Boehringer Ingelheim’s companion animal and cattle portfolios and strengthens the company’s position as a leading vaccine supplier.  Terms of the deal were not disclosed.

“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 world’s 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

About Boehringer Ingelheim Vetmedica, Inc.
Boehringer Ingelheim Vetmedica, Inc. (St. Joseph, MO), is a subsidiary of Boehringer Ingelheim Corporation based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.

TWYNSTA Combines Two Proven Treatments for Blood Pressure Reduction in Patients Likely to Need Multiple Treatments to Reach Blood Pressure Goal

Ridgefield, CT, October 19, 2009 - Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events  who are unable to take angiotensin-converting enzyme (ACE) inhibitors.¹ MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.  The FDA also approved a New Drug Application (NDA) for the combination agent Twynsta® (telmisartan/amlodipine) Tablets for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. 

“For those at high risk of cardiovascular events, it’s important to find a treatment that helps reduce their risk.  Further, two-thirds of people currently treated for hypertension are not at target blood pressure goals,” said Dr. James Young, professor of medicine and executive dean of the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University.  “The newly approved use of telmisartan for cardiovascular risk reduction in high-risk patients  who are unable to take an ACE inhibitor, and the availability of a telmisartan-amlodipine combination for hypertension, give patients and physicians much needed new treatment options for these chronic health problems.”

Patients at high cardiovascular risk may have a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack or high-risk diabetes with evidence of end-organ damage.  Some studies estimate that up to 20 percent of patients taking an ACE inhibitor experience side effects, usually cough, suggesting that some patients might be less likely to take this medication as prescribed.^2,3 The approval of this additional indication for MICARDIS is based on the largest clinical trial program ever undertaken with an ARB, involving more than 31,000 high-risk cardiovascular patients with normal blood pressure or treated high blood pressure with a history of a broad range of cardiovascular diseases.^2,4 The results of these studies supported that MICARDIS is more effective than placebo.¹

TWYNSTA combines the complementary blood pressure lowering effects of telmisartan, the active ingredient in MICARDIS, with the calcium channel blocker (CCB) amlodipine.  TWYNSTA is not indicated for cardiovascular risk reduction. The new medicine will be available in pharmacies in November 2009 in the following strengths:  40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg.

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.  Results demonstrate that TWYNSTA was generally well-tolerated and provided significant blood pressure reductions in a variety of hypertensive patient populations compared with placebo or monotherapy.⁵

“The approval of MICARDIS for cardiovascular risk reduction and TWYNSTA for hypertension  demonstrates Boehringer Ingelheim’s commitment to providing  valuable options for the treatment of cardiovascular disease,” said Dr. Thor Voigt, senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.  “New options are important for the ultimate goal of ensuring patients receive appropriate treatment based on their individual needs.”

About Hypertension
According to the American Heart Association, about one in three U.S. adults –approximately 73 million people – has high blood pressure, or hypertension.⁶ High blood pressure is most common in people over the age of 35, and is particularly prevalent among the following populations: female, black, middle-aged, elderly, and obese people, heavy drinkers and women taking birth control pills.⁷ However, because there are no symptoms, nearly one-third of people with high blood pressure are not aware that they have the condition.⁸ Left untreated, high blood pressure can lead to serious cardiovascular health risks, such as stroke, heart attack, heart failure or kidney failure.⁸

About Cardiovascular Disease
Cardiovascular disease (CVD) claims the life of one American every 37 seconds.⁹ According to the American Heart Association, approximately 80 million Americans have one or more forms of cardiovascular disease.⁹ Thirty-five percent of all deaths in the U.S., or approximately one in three, are due to cardiovascular diseases.¹⁰ Among those with CVD, 8 million Americans have experienced a heart attack (myocardial infarction) and 6.5 million have experienced a stroke.  Additionally, in 2005, 860,000 Americans died from cardiovascular diseases.⁹ It is estimated that the cost of CVD in the United States, including health care expenditures and lost productivity from deaths and disability, will be more than $475 billion in 2009.¹⁰

About Micardis® (telmisartan) Tablets
Telmisartan is marketed in the U.S. as MICARDIS Tablets by Boehringer Ingelheim Pharmaceuticals, Inc. 

MICARDIS is indicated for the treatment of hypertension.  It may be used alone or in combination with other antihypertensive agents.

MICARDIS is also indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. Because studies with telmisartan did not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared, consider using the ACE inhibitor first.

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients, symptomatic hypotension may occur after initiation of therapy with MICARDIS Tablets. This condition should be corrected prior to administration of MICARDIS Tablets, or treatment should start under close medical supervision.

As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. MICARDIS Tablets should be used with caution in these patients.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe CHF), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with MICARDIS Tablets.

In studies of ACE-inhibitors in patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. An effect similar to that seen with ACE inhibitors should be anticipated with MICARDIS Tablets.

Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should be used with caution and should include close monitoring of renal function. Concomitant use of telmisartan and ramipril is not recommended.

The most common adverse events occurring with MICARDIS Tablets at a rate of ≥1% and greater than placebo, respectively, were: upper respiratory tract infection (URTI) (7%, 6%), back pain (3%, 1%), sinusitis (3%, 2%), diarrhea (3%, 2%), and pharyngitis (1%, 0%).

With MICARDIS monotherapy and other angiotensin II receptor blockers and ACE inhibitors in general, BP response in blacks is noticeably less than in Caucasians.

No overall differences in effectiveness and safety of MICARDIS were observed in elderly patients compared to younger patients, but greater sensitivity of some older individuals cannot be ruled out.

In nursing mothers, nursing or MICARDIS should be discontinued.

For more information about MICARDIS or to receive a package insert please contact Boehringer Ingelheim Pharmaceuticals Inc. Drug Information Unit at 1-800-542-6257, option #4.

About Twynsta® (telmisartan/amlodipine) Tablets
Telmisartan/amlodipine is marketed in the U.S. as TWYNSTA Tablets by Boehringer Ingelheim Pharmaceuticals, Inc. 

TWYNSTA is indicated for the treatment of hypertension, alone or with other antihypertensive agents.  It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients, symptomatic hypotension may occur after initiation of therapy with TWYNSTA Tablets. This condition should be corrected prior to administration of TWYNSTA Tablets, or treatment should start under close medical supervision with a reduced dose.

Since the vasodilation induced by amlodipine in TWYNSTA is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering amlodipine, particularly in patients with severe aortic stenosis.

As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. TWYNSTA should be used with caution in these patients.

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering TWYNSTA to patients with severe hepatic impairment.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe CHF), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with TWYNSTA Tablets.

In studies of ACE inhibitors in patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. An effect similar to that seen with ACE inhibitors should be anticipated with TWYNSTA Tablets.

Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should be used with caution and should include close monitoring of renal function. Concomitant use of telmisartan and ramipril is not recommended.

Patients, particularly, those with severe obstructive coronary artery disease, may develop increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.

Closely monitor patients with heart failure.

In the placebo-controlled factorial design study, discontinuation due to side effects occurred in 2.2% of patients treated with the telmisartan/amlodipine combination and in 4.3% of the patients in the placebo group. The most common reasons for discontinuation of therapy with TWYNSTA Tablets were peripheral edema (0.5%), dizziness (0.4%), and hypotension (0.4%). The most common adverse reactions that occurred in ≥2% of patients and at a higher incidence than placebo were peripheral edema, dizziness, and back pain.

In clinical studies, the magnitude of blood pressure lowering with TWYNSTA in black patients approached that observed in non-black patients, but the number of black patients was limited.

In patients who are 75 years or hepatically impaired, amlodipine should usually be started or added at a dose of 2.5mg.

In nursing mothers, nursing or TWYNSTA should be discontinued.

For more information about TWYNSTA or to receive a package insert please contact Boehringer Ingelheim Pharmaceuticals Inc. Drug Information Unit at 1-800-542-6257, option #4.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Ridgefield, CT, October 6, 2009 —Boehringer Ingelheim Pharmaceuticals, Inc. today announced the launch of the Viramune® (nevirapine) tablets/oral suspension Co-Pay Savings Program, a special program that will allow patients to save up to $50 on their health insurance co-payment on every monthly refill of a VIRAMUNE prescription for up to one year. Any patient with a VIRAMUNE prescription who has health insurance coverage requiring a patient co-payment is eligible for the program.

A valuable feature of the program is the use of a MasterCard® debit card that is solely dedicated to the purchase of a VIRAMUNE prescription, which can be used at any pharmacy that accepts MasterCard.  The up to $50 rebate will be credited to the patient at the point-of-purchase as quickly as any MasterCard transaction.

“There is a growing reliance by patients on co-pay and patient assistance programs offered by pharmaceutical companies and this rebate program makes it easier for HIV/AIDS patients to benefit,” said Albert Ros, executive vice president of Sales and Marketing, Boehringer Ingelheim Pharmaceuticals, Inc.“Initiatives to ease the financial burden of health insurance co-payment for HIV/AIDS patients such as this one underscore our commitment to helping patients obtain the care and treatment they need.”

Patients can obtain the VIRAMUNE Co-Pay Savings Card through their healthcare providers. Patients need to activate their card by calling a toll-free hotline at 1-888-99-VIRAMUNE (1-888-998-4726) or logging onto www.viramune.com.

In addition, as part of the activation process patients can also enroll to receive free educational information and support from the Vlife on Therapy program.

Once activated, the VIRAMUNE Co-Pay Savings Card can be presented, together with a VIRAMUNE prescription, at any pharmacy that accepts MasterCard. The card will immediately deduct up to $50 from the co-payment for VIRAMUNE.

The VIRAMUNE Co-Pay Savings Card will also be accepted at mail order pharmacies.

Boehringer Ingelheim Patient Assistance Program
Boehringer Ingelheim is committed to ensuring that patients who need VIRAMUNE have access to the medication.  The Boehringer Ingelheim Cares Foundation Patient Assistance Program (BI PAP) provides Boehringer Ingelheim medications free of charge to eligible patients in financial need, including those without prescription drug coverage and low-income Medicare beneficiaries.  Patients in need of Viramune® (nevirapine) tablets/oral suspension should call 800-556-8317 to speak with a program representative or visit www.RxHope.com for information about the BI PAP including eligibility criteria and program applications.

VIRAMUNE Important Safety Information
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection. 

VIRAMUNE does not cure HIV or AIDS, and has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

VIRAMUNE can cause severe liver disease and skin reactions that can cause death. These reactions occur most often during the first 18 weeks of treatment, but can occur later. Patients need to ask their HCP about how to recognize symptoms of skin and liver problems. VIRAMUNE should be discontinued and not restarted in patients who have any of these reactions.

Any patient can experience liver problems with VIRAMUNE, but women and patients who have higher CD4+ counts when they begin VIRAMUNE treatment have a greater risk. A woman with CD4+ >250 cells/mm3, or a man with CD4+ >400 cells/mm3 should not begin taking VIRAMUNE unless they and their HCP have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk.

Do not take VIRAMUNE if you have severe liver problems. 

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. Patients who have a skin rash during the first 14 days should immediately contact their HCP and not increase their VIRAMUNE dose to twice a day. The total duration of the once-daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Other side effects that patients have experienced include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Changes in body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

Please see full Prescribing Information, including boxed WARNING, for VIRAMUNEatwww.VIRAMUNE.com.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Ridgefield, CT, September 29, 2009- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the conclusion of the linagliptin pivotal Phase III clinical trials, including more than 4,000 patients in 40 countries worldwide.  Phase II data for linagliptin were presented earlier this year at the annual American Diabetes Association (ADA) Scientific Sessions.  Full results from the Phase III trials will be presented at international scientific congresses in 2010 and beyond.

"Many diabetes patients do not achieve adequate blood sugar control with currently available medications, so there is a high degree of unmet medical need in this therapeutic area,” said Dr. Thor Voigt, senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We hope that Boehringer Ingelheim will have the opportunity to introduce a new treatment option for patients living with type 2 diabetes that can help patients and physicians better reach treatment goals."

Linagliptin belongs to the dipeptidyl peptidase 4 (DPP-4) inhibitor class, a newer class of oral hypoglycemics that target the incretin hormones GLP-1 and GIP, which are believed to be involved with regulating blood sugar.¹

There are approximately 23.6² million Americans and 246 million people worldwide³ with diabetes. Type 2 diabetes is the most common type of diabetes accounting for more than 90% of all diabetes cases in the developed world.⁴ Every ten seconds two people develop diabetes and one person dies from diabetes-related causes around the world.³ Each year, more than 200,000 people in North America³ and more than 3.8 million people worldwide die from diabetes and its complications³ – a number which is expected to increase by more than 50 percent over the next decade.⁴ Diabetes is a chronic disease that occurs when the body either does not properly produce or use the hormone, insulin.³

To address this unmet need, Boehringer Ingelheim is committed to researching and developing new compounds in this therapeutic area.

Boehringer Ingelheim is also investigating sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), which are a new, emerging class of antidiabetic compounds that block tubular reabsorption of glucose in the kidney.⁵ Phase IIb clinical trials for this innovative approach to diabetes treatment are underway.  There are currently no SGLT-2 inhibitors approved by the U.S. Food and Drug Administration (FDA).

About linagliptin
Linagliptin is a compound discovered by Boehringer Ingelheim and is being developed as an oral once-daily tablet for the treatment of type 2 diabetes. The primary objective of the clinical program was to evaluate the efficacy, safety and tolerability profile of linagliptin alone and in combination with commonly used oral diabetes treatments such as metformin, sulfonylureas and thiazolinediones (TZDs). The overall linagliptin clinical trial program includes longer term studies and also studies to assess the use of linagliptin in Type 2 diabetes patients with renal impairment.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

References

1. Nathan DM et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy.  Diabetes Care 21:1-11, 2008.
2. American Diabetes Association. 2007 National Diabetes Fact Sheet..
3. International Diabetes Federation. Diabetes Atlas. 3rd edn.  Brussels: International Diabetes Federation, 2006.
4. World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at:
   http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on: February 4, 2009.

5. Jabbour SA, et al. Sodium glucose co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic control in patients with diabetes. International Journal of Clinical Practice, July 2008. 62, 8, 1279-1284.
   

Ridgefield, CT, September 24, 2009 - Few people talk openly about having diabetes, so most of us have little understanding of what it feels like to live with diabetes every single day and how it can impact one’s every waking moment. That’s about to change.  In recognition of World Diabetes Day on November 14th, the Making Sense of Diabetes video contest is challenging people living with diabetes to visually reveal its impact on their lives through one of the five senses:  sight, hearing, taste, touch or smell. The contest is sponsored by the Diabetes Hands Foundation, a pioneering advocacy organization in social media, and made possible through support provided by Boehringer Ingelheim Pharmaceuticals, Inc.

“Diabetes affects people’s lives in profound and unexpected ways,” said Manny Hernandez, founder of the Diabetes Hands Foundation, who has been living with diabetes since 2002. “We smell insulin, savor glucose tablets, feel the poke of devices, react to our doctor’s words and see the life ahead of us. Diabetes is complex and we hope this video contest will help people express and share their diabetes experiences with the diabetes community as a whole as well as with people close to them.”

To enter the Making Sense of Diabetes contest,anyone with diabetes over the age of 18 is asked to record and submit to www.MakingSenseOfDiabetes.org a video (up to three minutes run time) that demonstrates life with diabetes through one of the five senses. The online video submission should express creativity and originality, be truthful, and convey emotion in a compelling, evocative and personal way.

The contest begins on September 28 and lasts through November 1. Each week will focus on one of the five senses. Three weekly finalists will be chosen based on number of unique views, average rating received, quantity and quality of comments received, creativity and originality and the compelling nature of the video in connection to the sense it is about.

Restrictions and limitations apply. Go to www.MakingSenseOfDiabetes.org for the official rules and regulations, prize information, online voting of weekly winners and contest submission guidelines.

About Diabetes
Approximately 23.6 ¹ million Americans and 246 million people worldwide² have diabetes. Type 2 diabetes is the most common type, accounting for more than 90% of all diabetes cases in the developed world.³ Each year, more than 200,000 people in North America² and more than 3.8 million people worldwide die from diabetes and its complications² – a number which is expected to increase by more than 50 percent over the next decade.³ Diabetes is a chronic disease that occurs when the body either does not properly produce or use the hormone, insulin.²

About Boehringer Ingelheim and Diabetes
In June 2009, Boehringer Ingelheim announced its pipeline of oral antidiabetic compounds, establishing itself in the type 2 diabetes therapeutic area.  The Company is investigating compounds in Phase II and Phase III clinical development worldwide.

About The Diabetes Hands Foundation
The Diabetes Hands Foundation is a 501(c)(3) nonprofit dedicated to connecting people touched by diabetes (those with diabetes as well as their loved ones) and raising diabetes awareness.

The roots of DHF go back to 2006, when the idea of creating a social network for a higher purpose was born, later turning into TuDiabetes.com®. EsTuDiabetes.com (a sister community in Spanish) followed, along with the Foundation’s first diabetes awareness program, Word In Your Hand™, which was born within the community.

TuDiabetes.com® started in March 2007 and EsTuDiabetes.com was launched in August 2007. With more than 16,000 combined members, both social networks have become top destinations for people searching for support and information about diabetes.

In March 2009, ChangeDiabetesNow.org was started to showcase educational materials created by diabetes community members while serving as an outlet for creative expression and raising diabetes awareness.  All of the awareness programs of the Diabetes Hands Foundation can be found on this web site.

For more information, please visit www.diabeteshandsfoundation.org.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

References

1. Centers for Disease Control. 2007 National Diabetes Fact Sheet.
2. International Diabetes Federation. Diabetes Atlas. 3rd edn.  Brussels: International Diabetes Federation, 2006.

3. World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on: February 4, 2009.
   

Ingelheim, Germany and St. Joseph, MO, September 21, 2009 - Boehringer Ingelheim, a global pharmaceutical group of companies, together with its U.S. animal health business Boehringer Ingelheim Vetmedica, Inc., announced today that it has entered into an agreement with Pfizer to acquire certain assets of Wyeth Pharmaceutical’s Fort Dodge Animal Health business upon the closing of the global Pfizer-Wyeth merger, which is expected to occur early in the fourth quarter. The deal, which is subject to anti-trust clearance, significantly increases the size of Boehringer Ingelheim’s companion animal and cattle portfolios.

If approved, the deal would clear the way for Boehringer Ingelheim to acquire a significant portion of the Fort Dodge product portfolio in several countries, as well as manufacturing and research facilities located in Fort Dodge, Iowa. In the U.S. and Canada Boehringer Ingelheim will own and market the pet and cattle vaccine lines as well as a wide range of pharmaceuticals for pets, cattle and other species. In Canada, several swine vaccines are also part of the package. In Australia, Boehringer Ingelheim will own and market the Fort Dodge pet vaccines and in some European countries and in South Africa certain cattle vaccines.

“Fort Dodge Animal Health is a global industry leader recognized for its commitment to cutting-edge research and development with a product portfolio that is an excellent strategic fit with our existing product lines,” said Hubertus von Baumbach, Member of the Board of Managing Directors of Boehringer Ingelheim responsible for Finance and Animal Health. “This acquisition gives us further opportunity to focus on the development of innovative animal health products through internal research and external collaboration to bring even greater benefit to veterinarians and animal owners.”

Prof. Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim added that, “The widening of our Animal Health business and our product portfolio is not a sales-driven decision, but rather is driven by the opportunity to add momentum to our strategy for organic growth since we will build more capabilities in the core vaccine segment and expand our already strong product lines. We look forward to applying our innovative culture to the products included in this acquisition.”

Boehringer Ingelheim Pharmaceuticals, Inc.
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 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 US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

About Boehringer Ingelheim Vetmedica, Inc.
Boehringer Ingelheim Vetmedica, Inc. (St. Joseph, MO), is a subsidiary of Boehringer Ingelheim Corporation based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.

For more information, please visit http://us.boehringer-ingelheim.com.

“We are proud to receive this recognition once again. We are committed to maintaining an inclusive environment where all of our employees feel respected,” said J. Martin Carroll, Boehringer Ingelheim President and CEO. “We will continue to look for ways to improve our current programs and introduce innovative new ones.”

The CEI rated 590 business in total, evaluating LGBT-related policies and practices including non-discrimination policies, transgender health benefits and domestic partner benefits. Boehringer Ingelheim’s efforts in ensuring LGBT equality in each of the survey’s main criterion earned it the prestigious 100 percent ranking.

About CEI
The CEI rated 590 businesses in total, evaluating LGBT-related policies and practices including non-discrimination policies, transgender health benefits and domestic partner benefits.

The Corporate Equality Index 2010 report is available at www.hrc.org/cei.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 U.S. $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Ridgefield, CT, August 30, 2009 - Boehringer Ingelheim today announced that results from the RE-LY^® (Randomized Evaluation of Long-Term Anticoagulant Therapy, Warfarin, Compared with Dabigatran) study - the largest atrial fibrillation (AF) outcomes trial ever conducted¹ (18,113 patients in 44 countries worldwide) – were presented for the first time at the European Society of Cardiology Congress and published online in the New England Journal of Medicine.² The primary objective of RE-LY was to assess the safety and efficacy of the investigational oral direct thrombin inhibitor, dabigatran etexilate against warfarin (titrated to INR 2.0 to 3.0) for the prevention of stroke in patients with non-valvular atrial fibrillation.¹

• Both doses of dabigatran etexilate were non-inferior to warfarin on the primary endpoint of reducing the incidence of stroke (including hemorrhagic) and systemic embolism (p<0.001)²
  
• Dabigatran etexilate 150mg BID was superior to warfarin in reducing the incidence of stroke (including hemorrhagic) and systemic embolism by 34% (RR 0.66, 95% CI, 0.53-0.82, p<0.001)²
  
• There was no significant difference in the rate of major bleeding for dabigatran 150mg BID compared to warfarin (3.11 percent/year, 3.36 percent/year, respectively p=0.31).²
• The rate of major bleeding with dabigatran etexilate 110mg BID (2.71 percent/year) was 20 percent lower compared to warfarin (p=0.003)²   

Also presented and published today were results in other outcomes from the RE-LY trial, including significantly lower incidence of  hemorrhagic strokes with both 150mg and 110mg BID doses (RRR 74 percent, p<0.001 and RRR 69 percent, p<0.001, respectively),² and a lower incidence of  vascular mortality with the 150mg BID dose (RRR 15 percent, p=0.04).² Abnormal liver function (ALT or AST > 3xULN with concurrent bilirubin >2xULN) did not occur more frequently among patients taking dabigatran etexilate 110mg BID, 150mg BID than warfarin (0.2 percent, 0.2 percent, and 0.3 percent respectively).²

"Up to 20 percent of strokes in the U.S. each year are associated with atrial fibrillation.  As clinicians, our main objective in managing patients with atrial fibrillation is to prevent stroke without increasing the risk of dangerous or life-threatening bleeds," said Dr. Michael Ezekowitz, professor & vice president, clinical research, Lankenau Institute.  "The study results seen with the two respective doses of dabigatran evaluated in RE-LY indicate that this compound has the potential to improve patient care.”

Over 2.3 million Americans³ have atrial fibrillation.  Atrial fibrillation is associated with a five-fold increase in the incidence of stroke.⁴   Strokes that are associated with AF tend to be especially severe and disabling,⁵ with half of people dying within one year.⁶   Warfarin and other vitamin-K antagonists are highly effective when patients’ blood clotting value is maintained within the therapeutic INR range of 2.0-3.0.⁷ However in clinical practice approximately half of patients with atrial fibrillation eligible for anticoagulation don not receive warfarin.⁸ For those patients receiving warfarin, only about half are controlled within the therapeutic range.⁹

“As a research-driven company focused on improving patient care, we are very pleased with the findings from the RE-LY study,” said J. Martin Carroll, president and CEO of Boehringer Ingelheim Pharmaceuticals, Inc. “The results suggest that dabigatran etexilate, a compound discovered and developed from the earliest stages in our laboratories, may bring a long-awaited advancement in oral anticoagulation to the millions of people living with atrial fibrillation.”
 
About RE-LY^® : The largest AF outcomes trial to date
RE-LY was a global, Phase III, randomized trial of 18,113 patients enrolled in more than 900 centers in 44 countries, investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.¹ Patients with non-valvular AF and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age > 75 years, age > 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension) were enrolled in the study for two years with a minimum follow-up period of one year.¹

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.¹⁰ Secondary outcome measures included a composite of incidence of stroke (including hemorrhagic), systemic embolism and all death, as well as a composite of incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).¹  Additional safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction, and other adverse events.¹

The primary analysis was designed to test whether either dose of dabigatran was non-inferior to warfarin.   After non-inferiority of both doses of dabigatran was established, statistical analysis allowed testing of superiority.

About AF and stroke
Atrial fibrillation is the most common sustained heart rhythm abnormality in the U.S.¹⁰ The prevalence of AF in the U.S. is expected to increase 2.5 fold to 5.6 million by 2050, reflecting the growing population of elderly individuals.³  Atrial fibrillation is associated with up to 20 percent of strokes in the U.S.¹⁰ Strokes related to AF are twice as likely to be fatal⁵ and twice as likely to be debilitating as non-AF related strokes.¹¹ Total annual costs for the treatment of AF are estimated to be more than U.S. $6.65 billion.¹²

About dabigatran etexilate
Dabigatran etexilate is an investigational oral direct thrombin inhibitor (DTI)¹³ , being studied in the prevention and treatment of acute and chronic thromboembolic diseases.^{1,14,15,16,17,18,19}

Dabigatran etexilate is not approved by the FDA.  Dabigatran etexilate is approved and marketed as Pradaxa^® in 40 countries outside the U.S. for the primary prevention of venous thromboembolic events (blood clots) in patients who have undergone elective total hip or elective total knee replacement surgery.

About the dabigatran etexilate clinical trial program
RE-LY® is part of Boehringer Ingelheim’s clinical trial program evaluating the efficacy and safety of dabigatran etexilate.^{1,15,16,17,18,19,20,21} In addition to RE-LY, the development program encompasses studies in:

• Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgeries ^15,16,17
• Treatment of acute VTE¹⁹
• Secondary prevention of VTE¹⁸
• Prevention of atherothrombotic events in patients with acute coronary syndrome¹⁴
• Stroke prevention in atrial fibrillation

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 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 U.S. $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Atrial fibrillation affects approximately 2.3 million Americans² and can increase the risk of stroke five-fold³ . Top-line findings from the 18,113 patient RE-LY study¹ will be featured in an ESC press briefing on Sunday, Aug. 30 at 8:00 a.m. CEST, with the full results presented in a “Hot-Line” session at 11:00 a.m. CEST.  The study will also be simultaneously published in a leading peer-reviewed medical journal.

Dabigatran etexilate is an investigational oral anticoagulant in Phase III development for stroke prevention in AF¹ and several other therapeutic areas, including prevention of atherothrombotic events in patients with acute coronary syndrome,⁴ as well as primary prevention,^5,6,7 secondary prevention⁸ and treatment of venous thromboembolism.⁹  Dabigatran etexilate is not yet approved by the U.S. Food and Drug Administration.

In addition to the primary findings, a RE-LY sub-analysis of treatment naïve patients will also be presented during a “Clinical Trial Update” session on Wednesday, Sept. 2 at 8:00 a.m. CEST.

About RE-LY: The largest AF outcomes trial to date
RE-LY was a global, Phase III, randomized trial of 18,113 patients¹ enrolled in more than 900 centers in 44 countries,¹ investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin – INR 2.0-3.0 – (open label) for stroke prevention.¹ Patients with non-valvular AF and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age > 75 years, age > 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension)¹ were enrolled in the study for two years with a minimum follow-up period of one year.¹

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.¹⁰ Secondary outcome measures included a composite of incidence of stroke (including hemorrhagic), systemic embolism and all death, as well as a composite of incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).¹⁰ Additional safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction, and other adverse events.¹