Biotech Values

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In DURATION-4 study Bydureon (f/k/a exenatide LAR) reduced A1c similarly to metformin and Actos, and produced average weight loss like metformin.

Amylin shares fall after new Bydureon data hits

http://www.reuters.com/article/idCNN1521747120100615?rpc=44

* Diabetes drug tops one oral drug, comparable to 2 others

* Bydureon longer-lasting version of Byetta

* Amylin shares down nearly 4 pct

By Lewis Krauskopf

NEW YORK, June 15 (Reuters) - Amylin Pharmaceuticals Inc (AMLN.O) and Eli Lilly and Co's (LLY.N) experimental diabetes drug Bydureon proved better at reducing blood sugar levels than one currently marketed medicine, but only comparable to two others, according to data released on Tuesday.

Shares of Amylin were down nearly 4 percent after the companies released results of the 820-patient study, called Duration-4.

Bydureon, which is injected once a week and is a longer-lasting version of the companies' Byetta drug, also known as exenatide, belongs to the GLP-1 class of drugs that stimulate insulin production in order to regulate blood sugar levels.

The study is the fourth comparing Bydureon -- a critical potential growth driver for both companies -- to other diabetes drugs.

U.S. regulators are expected by Oct. 22 to decide whether to approve Bydureon, which was developed with technology from Alkermes Inc (ALKS.O).

Duration-4 compared Bydureon to three oral medicines for Type 2 diabetes: Merck & Co's (MRK.N) Januvia, Takeda Pharmaceutical Co's (4502.T) Actos, and metformin, which is available generically.

Study participants were not achieving adequate control of A1C -- a common measure of blood sugar -- through diet and exercise, and were not on any diabetes therapy when they entered the study.

After 26 weeks of treatment, patients who received Bydureon experienced a reduction in A1C of 1.5 percentage points from baseline, which was deemed significantly greater than the 1.2 percentage points reduction seen with Januvia.

However, patients taking metformin also experienced a reduction in A1C of 1.5 percentage points, while patients receiving Actos saw a reduction of 1.6 percentage points.

"The results indicate that Bydureon is better than Januvia but comparable to metformin and Actos" in reducing A1C levels, Leerink Swann analyst Joshua Schimmer said in a research note.

Patients taking Bydureon, Actos and metformin all achieved an average A1C of less than 7 percent, which is the glucose control target recommended by the American Diabetes Association.

Bydureon treatment produced an average weight loss of 4.5 pounds (2 kg), which was statistically significantly greater than the average 1.7 pounds (0.8 kg) patients lost with Januvia and the average 3.3 pounds (1.5 kg) patients gained with Actos. But patients receiving metformin experienced an average weight loss of 4.4 pounds (2 kg).

Weight loss is considered an extremely desirable side effect as obesity is a leading cause of Type 2 diabetes, and some treatments for the disease lead to weight gain, as Actos did in this study.

"Our conclusion is that Duration-4 may do more to reinforce generic metformin as the front-line diabetes drug of choice than to support asking for broad front-line use of Bydureon," Robert W. Baird analyst Thomas Russo said in a research note.

Aside from Bydureon and Byetta, the GLP-1 class is closely watched by Wall Street and includes Novo Nordisk's (NOVOb.CO) Victoza and taspoglutide, under development by Roche Holding AG (ROG.VX) and Ipsen SA (IPN.PA).

Amylin shares had risen 4.5 percent on Monday after analysts said data on diabetes drugs from potential competitors looks less threatening than some had expected. [ID:nN14209306]

"We still see Bydureon as likely the dominant GLP-1 agonist," Schimmer said, "but are struggling to quantify the extent of market expansion for the class, which is equally important for forecasting Bydureon revenue and AMLN's profitability."