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FDA Approves Boehringer Ingelheim Corporation, Eli Lilly and Company (LLY)'s Tradjenta Tablets for the Treatment of Type 2 Diabetes


5/3/2011 6:47:01 AM

RIDGEFIELD, Conn. and INDIANAPOLIS, May 2, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE:LLY - News) today announced that the U.S. Food and Drug Administration (FDA) has approved Tradjenta™ (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With TRADJENTA, no dose adjustment is recommended for patients with kidney or liver impairment. TRADJENTA is a tablet that can be taken with or without food. TRADJENTA lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

"Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications," said John Gerich M.D., professor of medicine, University of Rochester School of Medicine. "The FDA approval of TRADJENTA is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. With TRADJENTA, physicians will have another option for managing type 2 diabetes, a potentially devastating condition."

TRADJENTA 5 mg once daily was approved based on a clinical trial program which included approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating TRADJENTA as monotherapy and in combination with the commonly prescribed medications for type 2 diabetes – metformin, sulfonylurea or pioglitazone. TRADJENTA showed statistically significant A1C reductions of up to 0.7 percent when used as monotherapy (compared to placebo). When used in combination with metformin, sulfonylurea, and metformin plus sulfonylurea, the addition of TRADJENTA resulted in significant A1C reductions of 0.6, 0.5, and 0.6 percent respectively (compared to placebo). In the initial combination of TRADJENTA plus pioglitazone, significant reductions in A1C of 0.5 percent were observed compared to placebo.

Treatment with TRADJENTA also produced significant reductions in fasting plasma glucose (FPG) compared to placebo, when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone. Treatment with TRADJENTA produced significant reductions in two-hour post-prandial glucose (PPG) levels compared with placebo as monotherapy and when used in combination with metformin. FPG is used to determine glucose levels in a fasting state (usually upon wakening in the morning), and PPG is used to determine glucose levels after meals (usually two hours after eating).

In controlled studies, change from baseline in body weight did not differ significantly between groups when TRADJENTA was administered as monotherapy, in combination with metformin or in combination with metformin plus sulfonylurea. Patients treated with TRADJENTA exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered sulfonylurea (-1.1 kg vs. +1.4 kg. p<0.0001). Patient weight increased in both the TRADJENTA plus pioglitazone and placebo plus pioglitazone groups during the study with an adjusted mean change from baseline of 2.3 kg and 1.2 kg, respectively (p=0.0141).

Adverse reactions reported in greater than or equal to five percent of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis. Hypoglycemia was more commonly reported in patients treated with the combination of TRADJENTA and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. The incidence of hypoglycemia was similar to placebo when TRADJENTA was administered as monotherapy or in combination with metformin or pioglitazone. Pancreatitis was reported more often in patients randomized to TRADJENTA (one per 538 person-years versus zero in 433 person-years for comparator).

"Type 2 diabetes is increasing at an alarming rate and we are proud to offer a new treatment option that could potentially help the millions of people with type 2 diabetes whose blood sugar is uncontrolled," said Albert Ros, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "When we introduce a new medicine to the marketplace, our goal is to improve patient care and we are hopeful that TRADJENTA will help do that."

The FDA approval of TRADJENTA marks the first regulatory milestone since the formation of the Boehringer Ingelheim and Eli Lilly and Company 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.

"Our alliance with Boehringer Ingelheim represents one of the most robust diabetes pipelines in the pharmaceutical industry," said Enrique Conterno, president of Lilly Diabetes. "TRADJENTA is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of Americans living with type 2 diabetes."

The overall clinical development program for TRADJENTA consists of 30 studies completed, underway or planned. TRADJENTA is currently under regulatory review in the EU and Japan.

To learn more about Tradjenta™ (linagliptin) tablets and for full prescribing information visit: www.TRADJENTA.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257 (option 4).

About Diabetes

Approximately 25.8 million Americans(1) and an estimated 220 million people worldwide(2) have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 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)

What are TRADJENTA tablets?

TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

It is not known if TRADJENTA is safe and effective when used with insulin.

Important Safety Information

Who should not take TRADJENTA?

Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.

Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.

What should I tell my doctor before taking TRADJENTA?

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin. If you take TRADJENTA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.

What are the possible side effects of TRADJENTA?

The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more safety information, please see Patient Information and full Prescribing Information.

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.

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 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 www.lillydiabetes.com.

This press release contains forward-looking statements about Tradjenta™ (linagliptin) tablets 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 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.

P-LLY

(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: April 27, 2011.

(2) World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on: April 27, 2011.

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


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