Thursday, March 10, 2011 at 3:56 p.m.
An experimental monthly version of Amylin’s type 2 diabetes drug exenatide worked as well as an experimental weekly version of the injected medication in a recent study, the San Diego drugmaker said Thursday.
Amylin is under pressure to get longer-term versions of exenatide onto the market to offset slowing sales of Byetta, the original twice-a-day version of the drug, which has been losing ground to longer-lasting competitors.
The weekly version, known as Bydureon, was rejected in October by FDA regulators who said they wanted new research data on how the weekly medication affects the heart. Amylin launched the study in February with plans to deliver results to the agency in the second half of this year.
In the latest test, the once-monthly version of exenatide reduced average blood-sugar levels, known as A1C, by between 1.3 percent and 1.5 percent in the Phase 2 clinical trial. Patients taking the weekly version of the drug, known as Bydureon, saw their A1C levels fall by 1.5 percent.
Shares of Amylin fell 9 cents, or nearly 1 percent, on Thursday to $11.26.
The Amylin report said little about how well the monthly drug was tolerated among study participants, Cowen and Co. stock analyst Phil Nadeau said in a note to clients.
“We find it hard to draw many firm conclusions on exenatide once monthly’s potential,” he said. “We expect Amylin will release additional data from the trial at a medical meeting in the future.”
The news came a week after Amylin shares plunged 25 percent after another study showed that Bydureon didn’t control diabetes better than Victoza, a commercially available once-daily injectable drug made by Novo Nordisk.
The company’s stock probably won’t stage a rebound until questions about Bydureon are resolved, said Mark Schoenebaum, a stock analyst with ISI Group in New York.
“Bydureon’s (heart) study remains to be the key catalyst for the stock in the near term,” he said.
All of the drugs are part of a class of injected diabetes medications known as GLP-1 agonists that has emerged in recent years to compete with orally administered therapies.
Diabetes has attracted the attention of numerous drug companies. About 25.8 million Americans now have the disease, and nearly 2 million new cases are diagnosed each year, according to the American Diabetes Association.
With the disease costing about $174 billion annually in the United States, physicians and insurers have pressed drug developers to come up with better medications for controlling the potentially deadly disease.
Some analysts have predicted that annual sales of the monthly version of exenatide could reach $1 billion if the medication ever makes it to market.
Amylin is developing the therapy with partners Eli Lilly of Indianapolis and Alkermes of Waltham, Mass.
In the latest study, 121 patients were randomly given monthly doses of exenatide or weekly shots of Bydureon for 20 weeks. The trial was designed to measure the monthly drug’s effectiveness, safety and tolerability, the company said. The most common side effects from exenatide were headaches and nausea.
Amylin plans to open talks with the FDA about whether they need to conduct additional Phase 2 tests on the drug or can move on to larger Phase 3 trials, Schoenebaum said.