Amylin Braces for Big Event of 2010, the (Hoped-For) Approval of Once-Weekly Diabetes Drug

Xconomy San Diego — 

Amylin Pharmaceuticals CEO Dan Bradbury likes to list his company’s priorities in a well-organized series of little bullet points. But this is the year the San Diego-based company is counting on one event to dwarf all others, as it seeks FDA approval for an injectable diabetes treatment that only needs to taken once a week.

I met Bradbury at his hotel last week during the JP Morgan Healthcare Conference in San Francisco, just a few hours before he gave a speech about the year ahead.. We discussed all the usual highlights about how Amylin (NASDAQ: AMLN) is (still) striving to turn consistently cash-flow positive by the end of this year, boost sales of its existing products, and advance some of the interesting products in the pipeline—including the novel obesity drug that few people are paying much attention to at all.

But that’s really taking a backseat to what is expected to happen by March 5. That’s the FDA’s deadline to complete its review of Amylin and Eli Lilly’s application to start selling exenatide once-weekly in the U.S. This is a first-of-its kind treatment that takes the active ingredient in Amylin’s top-selling drug, marketed as Byetta, and combines it with a polymer from Cambridge, MA-based Alkermes to make it last longer in the bloodstream. This is potentially a huge advance, in that the existing drug must be taken through twice-daily injections, while the newer one can control blood sugar levels more effectively with just one shot a week. Patients won’t have to worry as much about the peaks and valleys of drug concentration in their bloodstream that leads to a lot monitoring through pinpricks of blood.

An estimated 25 million people in the U.S. have diabetes, and the incidence is expected to double over the next 25 years as more young people get diagnosed, Bradbury says. Based on the average of nine Wall Street analysts, who are predicting revenues of $1.45 billion for Amylin in 2013, the bet appears to be that the company will double its sales from the current form of exenatide. The new drug has been tested in head-to-head studies against big-sellers like Merck’s sitagliptin (Januvia), Takeda Pharmaceuticals’ pioglitazone (Actos), and Sanofi-Aventis’ insulin glargine (Lantus) that are taken once a day.

Dan Bradbury

Dan Bradbury

“We have a tremendous opportunity with exenatide once-weekly,” Bradbury says “This product has demonstrated efficacy that’s greater, in terms of glucose lowering, than all commonly used branded diabetes medicines. It has the potential for weight loss. It’s dosed just once a week to provide continuous control. That means you have control 24 hours a day, seven days a week, 365 days a year. That whole concept of just providing control all the time is really important.”

Many stock analysts are predicting that Amylin and Lilly will be delayed by the FDA for one reason or another. This will obviously be one of the key points of speculation over the next six weeks, so I pressed Bradbury for a little more information that might help people handicap this long-anticipated event.

Right before Christmas, the FDA completed its inspection of Amylin’s $500 million factory in Ohio, which is the only place in the world set up to manufacture exenatide once-weekly, Bradbury says. The agency’s inspectors made some “observations” which he wouldn’t characterize, although he tried to downplay their significance. The agency’s remarks are “addressable,” probably without … Next Page »

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3 responses to “Amylin Braces for Big Event of 2010, the (Hoped-For) Approval of Once-Weekly Diabetes Drug”

  1. stevene says:

    REMS are not required on all products, Bradbury is misleading in his remarks. Drugs considered dangerous, such as Lilly’s Effient are required to have them…but NOT all are . An example is BMS’s Onglyza, no REMS, both of these drugs were approved last summer. Obviously the safety of Byetta will be an ongoing concern since it is a concern now.