* Says once weekly a significant opportunity over Byetta
* Says FDA requires no new toxicology studies
* Says approval could come in first half of 2010
NEW YORK, - Amylin Pharmaceuticals Inc's chief executive said he expects eventual sales of the company's experimental once-weekly diabetes medicine to be significantly higher than those of Byetta, a version of the drug that must be injected twice a day.
Amylin CEO Daniel Bradbury, speaking on Tuesday at the Goldman Sachs Healthcare Conference, declined to give specific forecasts for the sales potential of exenatide once weekly, which is awaiting a U.S. approval decision.
But taking into account the convenience advantage over regular Byetta, plus better efficacy, tolerability and cardiovascular profile, Bradbury said, "exenatide once weekly represents a significant opportunity over and above what we've seen with Byetta."
He noted that Byetta, an injected drug, has annual sales of about $700 million. That represents just 2 percent of the oral diabetes market.
Byetta, the first approved drug from the GLP-1 analog class of Type 2 diabetes medicines that work by stimulating release of insulin only when blood sugar levels are high, is co-marketed with Eli Lilly and Co.
Its sales were hurt last year when it was linked to cases of pancreatitis, but those concerns appear to have waned with further clinical data failing to show a direct connection.
Bradbury was discussing Amylin's drugs following the annual American Diabetes Association scientific meeting at which the company presented data demonstrating the superiority of the injectable exenatide once weekly over widely used oral diabetes medicines Januvia and Actos, sold by Merck & Co and Takeda Pharmaceutical Co, respectively.
EXPRESSED CONFIDENCE
Bradbury noted that new injectable drugs are always slower to catch on than pills, but he expressed confidence that Byetta sales would pick up and that the once weekly version will prove superior to similar medicines other companies are developing.
"I don't believe any of the Phase II compounds coming has demonstrated any benefit over exenatide once weekly. We believe it will be best in class and we can maintain that leadership over time," Bradbury said.
However, approval of exenatide once weekly is far from certain. A similar drug being developed by Danish diabetes company Novo Nordisk was linked to thyroid cancer in rats, raising concern about new approvals in the class.
Bradbury said the U.S. Food and Drug Administration was well aware of the thyroid cancer issue when Amylin was in discussion with the agency, but it was not asked to do any additional toxicology studies. He noted that the cancer turned up only in female rats given 30 times the human dose.
"Our goal is to gain once weekly approval as soon as possible," Bradbury said. "The standard timeline would be the first half of next year."
Amylin shares were down 23 cents, or 2 percent, at $11.26 in early afternoon trading on Nasdaq.
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