Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from a study comparing the effect of long-term treatment with either Byetta (exenatide) injection or Lantus(R) (insulin glargine) on overall beta-cell function. Three years of Byetta therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla. After three years of treatment, both therapies reduced...

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla. In the study, patients receiving insulin glargine, with...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of Bydureon (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications. The 26-week clinical study compared Bydureon monotherapy to Januvia(R) (sitagliptin), Actos(R) (pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010. Bydureon (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of...

Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM). In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing...

The Food and Drug Administration (FDA) announced that following the closure of FDA building due to extreme weather it was granting a five day extension for the review of Amylin Pharmaceuticals Inc and Eli Lilly and Co’s Exenatide Once Weekly New Drug Application. The new drug is part of a collaboration between the companies started in 2002, which includes the currently available twice daily type 2 diabetes drug Byetta. Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to Byetta (exenatide injection taken twice daily), in patients with type 2 diabetes. The tests showed that after 24 weeks of treatment, patients taking exenatide once weekly experienced a statistically superior reduction in A1C, of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for Byetta. Patients...

Novo Nordisk’s CEO, Lars Sorensen, told Reuters at the Reuters Health Summit in New York that the new diabetes drug Victoza has reached the final decision stage at the U.S. FDA.  Sorensen expects the drug will be approved, although “potentially all the outcomes are still possible. A rejection is still possible, a demand for refiling is still possible…” According to Sorensen, Victoza, which was approved in Europe in July, has been achieving rapid uptake in Europe and is set to overtake Eli Lilly’s and Amylin...

Today the FDA indicated that the safety label of Byetta would be modified to include potential kidney problems including possible kidney failure. According to the FDA website “From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta.” Seven million Byetta prescriptions were issued during this time, so this represents about 1 in 100,000 people being affected. Byetta is a drug taken to assist in the processing of blood sugar. It is one of a family of drugs...

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceuticals Company Limited announced an agreement to co-develop and commercialize pharmaceutical products for the treatment of obseity and related conditions.  Amylin, whose top product, Byetta,  had sales of $678.5 million last year. will receive a one-time up-front payment of $75 million from Takeda, the largest pharmaceutical company in Japan and maker of Actos, a best-selling diabetes drug.  In a press release, Takeda writes, “Under the terms of the agreement, Amylin will be...