March 3, 2011 / 1:46 PM / 7 years ago

Amylin, Lilly diabetes drug falls short of Novo's

NEW YORK (Reuters) - A long-awaited experimental diabetes medicine from Eli Lilly & Co and Amylin Pharmaceuticals Inc that patients need to inject only once a week failed to match up to a rival treatment taken daily, sending Amylin shares tumbling 25 percent.

Lilly, Amylin and partner Alkermes Inc released results of a head-to-head study on Thursday comparing their once-weekly Bydureon injection to Novo Nordisk A/S’s Victoza, which is injected daily. Bydureon is a longer-acting version of Byetta, another drug sold by Lilly and Amylin.

Lilly shares were off 1.1 percent, while Alkermes fell nearly 15 percent. Shares of Danish drugmaker Novo rose 4.5 percent.

Bydureon failed to meet the primary goal of proving it was as effective as Victoza, according to the results of the 26-week study.

Patients receiving Bydureon saw a reduction in A1C -- a common measure of blood sugar -- of 1.3 percentage points from their baseline levels. That compared to a 1.5 percentage-point reduction for Victoza patients.

The study, known as Duration-6, is the sixth study comparing Bydureon to other medications for controlling Type-2 diabetes. Bydureon and Victoza are both in the class of medicines known GLP-1 receptor agonists.

About 26 million children and adults in the United States have diabetes, according to the American Diabetes Association.

The Duration-6 results marked the latest disappointment for Amylin and Lilly over Bydureon, which has been viewed as crucial to sustaining the franchise started by Byetta.

In October, the U.S. Food and Drug Administration declined to approve Bydureon pending more data on its potential effect on heart rates. Amylin said in January that the Bydureon application would be resubmitted to the FDA in the second half of this year, and the agency’s review would probably take up to six months.

The Duration-6 results keep up the momentum for Novo, whose shares have soared more than 70 percent in the past year, helped by the fast start for Victoza.

Victoza may also see competition down the road from rival medicines such as GlaxoSmithKline Plc’s Syncria and Sanofi-Aventis’ lixisenatide, said Sanford Bernstein analyst Jack Scannell.

“It’s very clear there are going to be more GLP-1s but I think Victoza probably has a marketing advantage for the foreseeable future,” Scannell said.

Novo Chief Executive Lars Sorensen told the Reuters Health Summit in November that Victoza sales could reach $2.5 billion a year later this decade.

Reporting by Lewis Krauskopf, additional reporting by Ben Hirschler in London, editing by Michele Gershberg, Lisa Von Ahn, Dave Zimmerman

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