Jentadueto® (linagliptin/metformin hydrochloride) tablets recommended for approval

Eli Lilly and CompanyBoehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced they have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto® (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta® tablets, marketed under the trade name Trajenta® in Europe) and metformin in a single tablet taken twice daily. (1)

The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of JENTADUETO for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin. If approved by the European Commission, JENTADUETO will provide a new, single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose.(2)

"The CHMP positive opinion for JENTADUETO marks another important regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance, extending our commitment to bringing new medicines to those patients who need them," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Around the world, many people with type 2 diabetes require more than one treatment to adequately manage their blood sugar. By combining two important diabetes medicines in a single tablet, we believe that JENTADUETO will provide people with type 2 diabetes another way of improving control of their blood sugar."

JENTADUETO was approved by the U.S. Food and Drug Administration (FDA) in January 2012 as a prescription medicine used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.(1) In clinical studies, initial combination therapy with JENTADUETO was superior to metformin monotherapy and to placebo in improving hemoglobin A1c (HbA1c or A1C) and fasting plasma glucose (FPG), with a similar safety and tolerability profile. No meaningful change in body weight was noted in any treatment group.(1)

At the maximum dose of 2.5 mg (linagliptin)/1000mg (metformin HCl) BID, JENTADUETO demonstrated placebo-corrected reductions in A1C levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for JENTADUETO).(1) A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. JENTADUETO did not cause any meaningful change in body weight.(1) JENTADUETO can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes. JENTADUETO is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.(1) The JENTADUETO U.S. label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with JENTADUETO.(1)

Adverse reactions reported in greater than or equal to five percent of patients treated with JENTADUETO and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhea. Hypoglycemia was more commonly reported in patients treated with the combination of JENTADUETO and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator).(1)

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.

About Diabetes
Approximately 25.8 million Americans(3) and an estimated 366 million people worldwide(4) have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.(3) Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.(5)

JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

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 centers 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.

About 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 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 endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

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.

1. Jentadueto® (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012
2. Data on File
3. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of health and Human Services, Center for Disease Control and Prevention, 2011.
4. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2011.
5. International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? Accessed on: February 22, 2012.