Lilly Diabetes Drug Clears European Hurdle

July 25, 2012

News Release

RIDGEFIELD, Conn. and INDIANAPOLIS, Ind. - Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the receipt of Marketing Authorization from the European Commission for 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.

The European Commission has approved 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, metformin and a sulfonylurea, or those already being treated with the combination of linagliptin and metformin. It may be used with a sulfonylurea, as well. JENTADUETO provides a new, single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose.

"We're delighted that the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance can make JENTADUETO available to adult patients with type 2 diabetes across Europe," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Many patients need more than one treatment to adequately manage their diabetes. JENTADUETO offers patients with type 2 diabetes a single-tablet dosing option to improve control of their blood sugar."

Recently, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) issued a joint statement that noted it may be justified to begin initial therapy with a combination of two noninsulin agents or with insulin itself for patients with a high baseline hemoglobin A1c (HbA1c or A1C) of greater than or equal to 9.0 percent.

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. 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. In clinical studies, initial combination therapy with JENTADUETO was statistically superior to metformin monotherapy and to placebo in improving 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.

In initial therapy, the maximum dose of 2.5 mg (linagliptin)/1000mg (metformin HCl) BID, JENTADUETO showed placebo-corrected reductions in A1C levels of 1.7 percent (+0.1 percent for placebo and -1.6 percent for JENTADUETO). 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. 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.

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).

Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the U.S., and Trazenta in Japan, as well as in additional markets.

About Diabetes

Approximately 25.8 million Americans and an estimated 366 million people worldwide 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. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

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. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

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.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

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.

Source: Eli Lilly and Co.