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Δευτέρα 12 Μαρτίου 2012

Boehringer Ingelheim, Lilly launch new oral type 2 diabetes drug Jentadueto in US


Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies, and Eli Lilly and Company announced Jentadueto (linagliptin/metformin hydrochloride) tablets are now available by prescription in many leading chain and independent pharmacies across the US.

Jentadueto is a new prescription medication for patients who need to control their blood sugar. Taken twice daily, it combines two diabetes medicines — the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin and metformin — in one tablet. Linagliptin is marketed in the US as Tradjenta 5mg once-daily tablets. Jentadueto was approved by the US Food and Drug Administration (FDA) on January 30, 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.
Jentadueto is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine) and it has not been studied in combination with insulin. The product 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.

“By combining two important diabetes medicines in a single tablet, Jentadueto provides people with type 2 diabetes another option to control their blood sugar,” said David Pass, PharmD, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. “Making Jentadueto available quickly following its approval further demonstrates Boehringer Ingelheim and Lilly's shared commitment to address the needs of the millions of Americans living with type 2 diabetes.”

Jentadueto provides physicians with options to adjust the metformin dosing based on effectiveness and tolerability. It is available in three dosage strengths, taken twice daily: 2.5 mg linagliptin/500 mg metformin hydrochloride; 2.5 mg linagliptin/850 mg metformin hydrochloride; and 2.5 mg linagliptin/1000 mg metformin hydrochloride. Boehringer Ingelheim and Lilly are actively working with insurance companies on formulary coverage to have Jentadueto reimbursed at a co-pay level similar to other preferred branded products.

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

Along with the availability of Jentadueto, Boehringer Ingelheim and Lilly also announced today that a Savings Card Program is available for patients who qualify.

Under the programme, most commercially insured eligible patients at least 18 years of age will pay as little as $10 per month, with savings of up to $150 per monthly prescription. An eligible patient is responsible for any additional cost beyond the $150 maximum covered by this offer for each monthly prescription. Eligible cash-paying patients will receive up to $150 in savings per 30-day supply of Jentadueto.

Savings Card Programme key points: eligible patients can activate their Jentadueto Savings Card by visiting www.Jentadueto.com or calling 1-888-232-8458, if activated by May 31, the card is valid for prescriptions filled during 24 consecutive months from date of activation. If activated between June 1, 2012 and May 31, 2013, the card is valid for prescriptions filled during 12 consecutive months from date of activation, once activated, patients must present the Savings Card to the pharmacist along with a signed prescription for Jentadueto to receive savings. Patients are 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 will be valid in the United States including the District of Columbia and Puerto Rico.

This card is not valid for residents of Massachusetts or where otherwise prohibited by law. The offer is limited to one per patient. By accepting this offer, patients agree that if they are required to do so under the terms of their insurance coverage for this prescription or are otherwise required to do so by law, they should notify their insurance carrier of their redemption of the Savings Card. For questions regarding eligibility or benefits or to discontinue participation, call the JENTADUETO Savings Card Program at 1-877-512-4246 (8:00 AM - 8:00 PM EST, Monday – Friday). Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company reserve the right to rescind, revoke or amend this offer at any time without notice.

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 patients, 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 and eligibility requirements.

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 programme, applications can be sent only to people at least 18 years of age.

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 per cent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

Jentadueto is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. It 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 Jentadueto is safe and effective when used with insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres 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.