CHMP recommends indication for the use of Trajenta® (linagliptin) tablets as add-on therapy to insulin in adults with Type 2 Diabetes in Europe

Proposed indication further expands the use of linagliptin in a wide range of Type 2 Diabetes (T2D) patients

For Non-U.S. and Non-UK Media

Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a Positive Opinion from the European Medicines Agency’s (EMA) medicinal committee recommending expanding the therapeutic indication for the DPP-4 inhibitor Trajenta^® (linagliptin). If approved by the European Commission, this will expand the indicated use of Trajenta^® by the combination with insulin in adults with Type 2 Diabetes.

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of linagliptin in combination with insulin with or without metformin, when this regimen alone, with diet and exercise does not provide adequate glycaemic control. The CHMP’s Positive Opinion is based on data from a number of clinical studies, including efficacy data from a phase III trial of at least 52 weeks duration demonstrating the efficacy and safety of linagliptin in combination with basal insulin (primary endpoint: efficacy after 24 weeks). The trial results showed that after 24 weeks, adding linagliptin to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycaemia.¹

“Many patients with Type 2 Diabetes taking insulin require additional medication for adequate blood glucose control. This CHMP positive opinion is an important step towards offering further treatment options to those with Type 2 Diabetes,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Linagliptin is the first diabetes treatment in which one dose is the right dose for all patients. Linagliptin has a unique excretion pathway meaning no dose adjustment nor additional drug monitoring is required regardless of renal or hepatic function.”

For more information please see: www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/21_september_2012linagliptin.html

About Linagliptin

Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase-4) which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homoeostasis.²

Linagliptin (5 mg, once-daily) is marketed as Trajenta^® across Europe and Canada, as Tradjenta™ in the US, and Trazenta^® in Japan, as well as in additional markets.^2,3

Linagliptin is a prescription medicine that is used along with diet and exercise to lower blood glucose in adults with Type 2 Diabetes.^2,3 Linagliptin is not for people with Type 1 Diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).^2,3

About the Clinical Trial

Insulin add-on therapy trial
The efficacy of linagliptin as add-on to insulin therapy was evaluated in a 52-week randomised, double-blind, placebo-controlled trial with the primary endpoint measured after 24 weeks. In the trial, a total of 1,261 patients with type 2 diabetes inadequately controlled on insulin glargine, insulin detemir, or NPH insulin were randomised to receive either linagliptin 5 mg once daily or placebo. The trial included patients with a baseline HbA_1c of ≥7% and ≤10%, including 709 patients with renal impairment, most of whom were categorised as having mild renal impairment (eGFR 60 to <90 ml/min). HbA_1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. Patients were kept on a stable dose on insulin prior to and during the trial for the first 24 weeks. A total of 16.1% of patients did not take oral antidiabetic drugs at baseline, 75.6% took metformin only, 7.3% took both metformin and pioglitazone, and 1.0% took pioglitazone only.¹

At 24 weeks, linagliptin on a background of insulin therapy demonstrated a placebo-adjusted reduction in hemoglobin HbA_1c of -0.65% from a baseline HbA_1c of 8.3%. The differences in HbA_1c seen between linagliptin and placebo were comparable for patients with or without renal impairment, and regardless of the severity of impairment. The overall frequency hypoglycaemia (linagliptin, 25.7%; placebo, 27.3%) was not higher with linagliptin than with placebo. Overall body weight did not differ significantly between treatment groups.¹

About Diabetes

An estimated 366 million people worldwide have diabetes.⁴ Type 2 Diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.⁴ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.⁵

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com .

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 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com .

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com .

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programs and more – to make lives better.

For more information, visit www.lillydiabetes.com .

This press release contains forward-looking statements about linagliptin tablets. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

No. No. No.

¹ Boehringer Ingelheim. Data on File
² Trajenta^® (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002110/WC500115745.pdf
³ Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.
⁴ International Diabetes Federation. Diabetes Atlas 5th edn. www.idf.org , 2011.
⁵ World Health Organization: Fact Sheet No. 312 What is Diabetes?, 2010.

Contact:

Boehringer Ingelheim GmbH
Ute E Schmidt
Phone: +49 (6132) 77-97296
Email: press@boehringer-ingelheim.com
or
Lilly Diabetes
Tammy Hull
Communications Manager
Phone: +1 (317) 651-9116
Email: hullta@lilly.com