The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The EU approval was given after a clinical trial of patients using fixed-dose  Byetta with titrated basal insulin.  The patients in the trial achieved better postprandial and overall glycemic control, without weight gain...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in the European Union (EU) for the expanded use of Byetta (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults. The CHMP’s decision is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on...

The newly approved type 2 diabetes drug  Bydureon, made by Amylin Pharmaceuticals and Alkermes plc, is now available by prescription in U.S. pharmacies. Bydureon is the first and only once-weekly treatment for type 2 diabetes.  It was approved by the US FDA on January 27th 2012 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with  Bydureon  resulted in improvements in...

Amylin Pharmaceuticals and Eli Lilly and Company have agreed to terminate their alliance for type 2 diabetes drug, BYETTA (exenatide), and resolve the outstanding litigation between the companies. As part of the agreement, Amylin will take full responsibility for the worldwide development and commercialization of exenatide, starting in the United States (U.S.) on November 30, 2011, and progressing to all markets by the end of 2013.    After nearly a decade-long partnership that achieved a number of important milestones on behalf...

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly’s type 2 diabetes drug, Byetta (exenatide) injection.  Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. The FDA approved Byetta as an add-on therapy to Lantus following a clinical trial where patients using Byetta with insulin glargine achieved...

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced new analyses from the DURATION-3 and DURATION-4 trials demonstrating patients treated with the investigational medication Bydureon (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving Bydureon for the treatment of type 2 diabetes experienced improvements in composite endpoints...

Results from a retrospective analysis of more than 778,000 patients showed the addition of Byetta (exenatide) injection to pre-existing diabetes treatment regimens was associated with a reduced likelihood of heart failure, especially among patients receiving insulin. These findings were presented by Amylin and Eli Lilly in a poster session at the 71st Scientific Sessions of the American Diabetes Association in San Diego on June 25. The retrospective analysis used data from the GE Healthcare Centricity electronic medical record...

Amylin, Eli Lilly and Alkermes, announced results from long-term extensions of the DURATION-1 and 3 studies evaluating Bydureon (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The studies will be presented at the 71st Scientific Sessions of the American Diabetes Association. Data from the DURATION-1 study showed that after three years, patients receiving Bydureon experienced a significant reduction in A1c (1.6 percentage points) and weight (5.1 pounds) compared to...

U.S. District Court for the Southern District of California granted Amylin Pharmaceuticals a temporary restraining order (TRO) related to its litigation with respect to the Amylin / Lilly diabetes collaboration agreement. The TRO restrains Lilly from proceeding with its plans to use the same sales force to sell both exenatide and Boehringer Ingelheim’s competitor drug, linagliptin. The court also enjoined Lilly from disclosing any confidential information about exenatide to any of its sales representatives or employees...

Amylin Pharmaceuticals announced that it has filed a lawsuit against Eli Lilly.  Amylin alleges Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements to maximize commercialization of exenatide currently marketed as BYETTA® (exenatide) injection.  In 2002 the two companies entered an alliance for the global development and commercialization of exenatide, a medicine indicated as a first line treatment for type 2 diabetes. Exenatide is also the active ingredient in BYDUREON(TM) (exenatide...