any need for further inspection, in a timely manner, Bradbury says.
“We don’t believe they will affect the agency’s ability to complete the review” by the March 5 deadline, he says.
Amylin has suffered from declining sales of its flagship exenatide (Byetta) product since the FDA warned physicians in September 2008 about cases of patients on the drug who developed pancreatitis. Amylin has repeatedly stated that it sees no causal link between its drug and the condition. Even so, the FDA has been on the lookout for ways to minimize rare, but serious adverse side-effects like this, which means that Amylin now expects its new product to have what’s known as a risk evaluation and mitigation strategy (REMS) on the market from Day 1.
While some of these kinds of programs have caused delays for other companies, Bradbury told me he’s counting on it for exenatide once-weekly, and that essentially, he doesn’t think it’s going to create any onerous steps that will get in the way of a successful market rollout.
“Today with approval of every new product, there is a REMS program,” Bradbury says. “REMS programs vary from the benign to the very arduous.” He added, “We don’t believe any REMS program associated with exenatide once-weekly would delay us in launching the product.”
He covered some of that material in his presentation at the JP Morgan conference. But later in our conversation, Bradbury talked a little more than he usually does in public about some of the company’s long-range plans for the exenatide franchise.
By 2012, Amylin and Lilly are planning to introduce another version of the exenatide once-weekly product that can be injected through a pre-filled pen. Further down the road, the biotech has its eyes on a suspension form of the product that can be injected directly, and which raises the possibility that it could be given in as little as one injection a month. At an even earlier stage of development, Amylin is studying “non-invasive” delivery of its anti-diabetes drug, either through a transdermal formulation that pushes it through the skin without using a needle, or through a nasal spray, Bradbury says. Amylin isn’t pursuing an inhalable form of exenatide, knowing how much trouble Pfizer had in commercializing one such product in the past.
While those could be some of the big stories at Amylin in 2012, 2013, and beyond, they certainly won’t get a lot of air time this year. All eyes are going to be on what the FDA does by March 5 with the exenatide once-weekly application.
“We have the plan and the resources to launch exenatide once-weekly,” Bradbury says. “We intend to establish exenatide once-weekly as the new gold standard for the treatment of diabetes.”
