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Boehringer Ingelheim’s diabetes pipeline continues to advance as the Company announces conclusion of robust Phase III clinical program for linagliptin

Phase III data slated for presentation at international scientific congresses in 2010

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.

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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.
   

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