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FDA Approves Jentadueto

FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes

RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 30, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets.

Jentadueto is a prescription medication 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. At the maximum dose, Jentadueto demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) or A1C) levels of up to 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 sugar 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. The Jentadueto 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.

"Most people with type 2 diabetes require more than one medication to help lower their blood sugar, due to the complex nature of type 2 diabetes," said Lance Sloan, MD, Texas Institute for Kidney and Endocrine Disorders. "The approval of Jentadueto is exciting because it combines two diabetes medications in a single tablet, making it a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate."

Jentadueto Clinical Trials

In a 24-week, randomized, double-blind, placebo-controlled factorial study evaluating 791 adult patients with type 2 diabetes and inadequate glycemic control with diet and exercise, linagliptin plus metformin demonstrated the following:

Placebo 5 mg linagliptin once-daily 500 mg metformin twice-daily 2.5 mg linagliptin/500 mg metformin twice-daily 1,000 mg metformin twice-daily 2.5 mg linagliptin/1,000 mg metformin twice-daily
A1C (%)
Change from baseline (adjusted mean) +0.1 -0.5 -0.6 -1.2 -1.1 -1.6
Difference from placebo (adjusted mean) -- -0.6 -0.8 -1.3 -1.2 -1.7
*FPG (mg/dL)
Change from baseline (adjusted mean) +10 -9 -16 -33 -32 -49
Difference from placebo (adjusted mean) -- -19 -26 -43 -42 -60

*Fasting plasma glucose (FPG) is used to determine glucose levels in a fasting state (usually upon waking in the morning).

Jentadueto was approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects.

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 (22.9 percent versus 14.8 percent, respectively). Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person years versus zero in 433 person years for comparator).

"We are proud to bring this important, new, single-tablet treatment option, taken twice-daily, to the millions of people currently living with type 2 diabetes," said David Pass, PharmD, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We are hopeful that Jentadueto, the newest member of the growing family of products from the Boehringer Ingelheim and Lilly diabetes alliance, may help people living with blood sugar levels that are not controlled."

The FDA approval of Jentadueto marks the second U.S. approval since the formation of the Boehringer Ingelheim and Lilly worldwide diabetes alliance in January 2011. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.

About Diabetes

Approximately 25.8 million Americans(1) and an estimated 366 million people(2) worldwide have diabetes, according to 2010 data from CDC and 2011 data from IDF. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.(1) Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.(3)

About 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 http://www.boehringer-ingelheim.com or http://www.lilly.com.

About 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 145 affiliates and more than 42,000 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.

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 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

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 http://www.lilly.com.

About Lilly Diabetes

For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy – practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. For more information, visit http://www.lillydiabetes.com.

This press release contains forward-looking statements about Jentadueto and TRADJENTA for the treatment of type 2 diabetes. 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 commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that Jentadueto or TRADJENTA 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.

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JD127402 PR

(1) Centers for Disease Control and Prevention. National Diabetes Fact Sheet 2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: January 23, 2012.

(2) International Diabetes Federation. Diabetes Atlas Fact Sheet. 5th edn. Brussels: International Diabetes Federation, 2011.

(3) International Diabetes Federation. Diabetes Atlas. 3rd edn. Brussels: International Diabetes Federation, 2006.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

(Logo: http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )

SOURCE Eli Lilly and Company

CONTACT: Anna Moses, Public Affairs & Communications, Boehringer Ingelheim Pharmaceuticals, Inc., usnews@boehringer-ingelheim.com, 203-798-4638; Tammy Hull, Communications Manager, Lilly Diabetes, hullta@lilly.com, 317-651-9116

Web Site: http://www.lilly.com

Posted: February 2012

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