News Release

RIDGEFIELD, Conn. and INDIANAPOLIS, June 15, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced Tradjenta™ (linagliptin) tablets are now available by prescription in pharmacies across the United States including Walgreens, CVS, Rite Aid and many leading chain and independent pharmacies. The U.S. Food and Drug Administration (FDA) approved TRADJENTA on May 2, 2011 as a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. 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.  

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"The rapid availability of TRADJENTA for adults with type 2 diabetes following FDA approval is a testament to Boehringer Ingelheim and Lilly's joint commitment to improving patient care," said Wa'el Hashad, vice president, cardiovascular and metabolic disorders, Boehringer Ingelheim Pharmaceuticals, Inc. "The health of patients is our first priority and we work diligently to ensure our medications are accessible for patients. With just one dose to remember for all patients, TRADJENTA is an important new treatment option that could help the millions of Americans living with type 2 diabetes."

Boehringer Ingelheim and Lilly are in active discussions with various insurance companies about formulary coverage and are seeking for TRADJENTA to be reimbursed at a co-pay level similar to other preferred branded products. The wholesale acquisition price for TRADJENTA is $6.77 per tablet.

A Savings Card Program for TRADJENTA is available for patients who qualify. As part of the program, most commercially insured eligible patients pay no more than $10 per month with a maximum savings of $150 per month. Eligible cash-paying patients without commercial prescription coverage receive up to $150 in savings per 30-day supply of TRADJENTA. The Savings Card Program is valid for up to 24 months and is now available in many doctors' offices and online. Patients are not eligible if prescriptions are paid in part or full by any state or federally funded programs. For any questions regarding eligibility or benefits, visit www.TRADJENTA.com or call the TRADJENTA Savings Card Program at 1-877-512-4246 (8:00 a.m. - 8:00 p.m. ET, Monday through Friday).

In addition, the Boehringer Ingelheim Cares Foundation Patient Assistance Programs make Boehringer Ingelheim medicines, including TRADJENTA, available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

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. It 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.

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 was approved based on a clinical trial program that 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 some 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.  

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).

To learn more about TRADJENTA 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.

About the TRADJENTA Savings Card Program

Under the program, most commercially insured eligible patients will pay no more than $10 per month with a maximum savings of $150 per month.* Eligible cash-paying patients without commercial prescription coverage will receive up to $150 in savings per 30-day supply of TRADJENTA. The activation deadline is May 31, 2012, and this offer is only valid for prescriptions filled during 24 consecutive months from the date of activation. Limit 1 card per patient.

Note: Skipped months will not be added to the end of patients' 24-month period.

Savings Card program key points:

• Patients can activate their TRADJENTA Savings Card by going online at www.TRADJENTA.com or calling 1-888-879-0466.
• If activated on or before May 31, 2012, the Savings Card will be valid for 24 months. If activated on or after June 1, 2012, the Savings Card will be valid for 12 months.
• Once activated, the card must be presented to the pharmacist along with a signed prescription for TRADJENTA to receive savings.
• Patient not eligible if prescriptions are paid in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or TriCare and where prohibited by law. This offer is not valid in Massachusetts.
• For questions regarding eligibility or benefits or to discontinue participation, call the TRADJENTA Savings Card Program at 1-877-512-4246 (8:00 a.m. to 8:00 p.m. ET, Monday through Friday).
• Boehringer Ingelheim Pharmaceuticals, Inc., and Lilly USA, LLC, reserve the right to rescind, revoke, or amend this offer at any time without notice.

*Patient is responsible for any additional copay beyond the $150 maximum covered by this offer for each monthly prescription.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs

For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

To receive an application or inquire about the BI-PAP, please call 1-800-556-8317. Please note, while people of all ages are eligible for the program, applications can be sent only to people at least 18 years of age. To apply online go to www.RxHope.com.

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 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)

What is TRADJENTA?

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 is 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 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.

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(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: June 14, 2011.

(2) World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at: http://www.who.int/mediacentre/factsheets/fs312/en/.  Accessed on: June 14, 2011.

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

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company