Amylin Pharmaceuticals CEO Dan Bradbury was brimming with enthusiasm at the JP Morgan Healthcare Conference one year ago. San Diego-based Amylin (NASDAQ: [[ticker:AMLN]]) was psyched about what many analysts thought was a slam-dunk FDA approval for the first diabetes drug that can be injected just once a week.
Last week at the same conference, Bradbury was his usual upbeat self. But the message now is about keeping the ship steady for another year and half before his team can really fire away with the product that represents the future of the company, exenatide once-weekly (Bydureon).
“We need to look after our economic future with our existing products-Byetta and Symlin, and continue to manage our expenses appropriately so we can give ourselves the opportunity to benefit from the Bydureon launch,” Bradbury said during an interview last week at the JP Morgan confab.
Bradbury acknowledged that it took a week or two for the company to get over the shock it suffered in October, when the FDA refused to approve the new diabetes drug. Regulators insisted that the company provide more data on the drug’s effect on heart rhythms. “We were so surprised, and so disappointed,” Bradbury says. “But internally, our resolve has only gotten greater.”
The problem of diabetes certainly isn’t going away anytime soon. One month after the FDA dealt Amylin and its partners Eli Lilly and Alkermes the setback on Bydureon, UnitedHealth Group issued a report saying it expects about half of all Americans to have diabetes or pre-diabetes by the end of this decade. This chronic condition, in which people fail to properly control their blood sugar, leads to a host of symptoms that will cost the U.S. about $3.4 trillion in the 10 years through 2020, according to UnitedHealth, the nation’s largest health insurer. You can expect Bradbury to talk more about this growing health problem, and what drugmakers need to do to combat it, at the next Xconomy event, “San Diego’s Fight Against Diabesity” coming up on January 27th.
I’m sure Bradbury would love to take a victory lap at this event, but as it stands, the conversation will be more about how companies can cope with tough new scrutiny from the FDA toward diabetes treatments. The agency was burned by past safety controversies with GlaxoSmithKline’s rosiglitazone (Avandia) for diabetes and Abbott Laboratories’ sibutramine (Meridia). The news for most diabetes and obesity drugmakers has been bleak. Not just Amylin, but San Diego-based Arena Pharmaceuticals (NASDAQ: [[ticker:ARNA]]), Mountain View, CA-based Vivus (NASDAQ: [[ticker:VVUS]]), and Valencia, CA-based MannKind (NASDAQ: [[ticker:MNKD]]) have all been dealt painful setbacks at the FDA lately. San Diego’s Orexigen Therapeutics (NASDAQ: [[ticker:OREX]]) won a positive recommendation from an FDA advisory panel last month, but is still awaiting official word on whether its obesity drug is ready for sale in the U.S.
The biggest job at Amylin this year will be putting together the data the FDA asked for on QT prolongation, an effect in which some drugs cause irregular heart rhythms. Then it will have to re-submit an amended application, and wait as much as six months for the agency to complete its review, Bradbury says.
Bradbury insists he’s confident Bydureon will eventually win the green light from the FDA to enter the U.S. market. It would be horrible if it didn’t—the company has run five
