Amylin, Dark Horse of the Obesity Drug Battle, Follows Fast Behind Arena, Orexigen

9/14/09Follow @xconomy

The competition to create new obesity drugs is usually portrayed as a three-way battle royal among San Diego’s Arena Pharmaceuticals, crosstown rival Orexigen Therapeutics, and Mountain View, CA-based Vivus. Yet there’s one more San Diego biotech company with a drug in an earlier phase of development, Amylin Pharmaceuticals, which may just have the most effective weight loss drug of the bunch.

This is the story of Amylin’s effort to resurrect one of the biotech industry’s notorious flame-outs of the 1990s—leptin. We first told the tale back in October of how Amylin plucked this drug from Amgen’s scrap heap, reimagined it in tandem with its diabetes drug pramlintide (Symlin), and took another shot to see if leptin would ever live up to all that misplaced hype from years ago.

Obesity is one of the nation’s biggest public health problems, and drug companies know the winner in this category might dominate the biggest pharmaceutical market ever. In this couch-loving, junk-food eating culture, health officials now say two-thirds of U.S. adults have become overweight or obese. Yet Big Pharma has been gun shy about this market opportunity since Wyeth was burned by the multi-billion legal payments related to heart damage patients suffered from the fen-phen drug combo in the 1990s, and Sanofi-Aventis failed to win approval two years ago for a drug that was linked to rare cases of suicidal thoughts. If any of the new contenders can assure the FDA their drugs are truly safe, obesity drugs will again become a popular culture tsunami, and will be pitched as a catch-all for illnesses related to obesity—like diabetes, high blood pressure, high cholesterol, and depression.

Leptin was once hailed as the magic bullet for obesity based on rat studies in the 1990s. Amylin (NASDAQ: AMLN) isn’t ready to make any breathless claims yet, but its combination of pramlintide and a genetically modified form called metreleptin has shown far more convincing evidence from human trials that it has discovered something potentially big. It’s also an injection designed to melt away fat in a different way than the others, which mainly hit receptors in the brain that control the body’s feeling of fullness.

“This is a big deal,” says Amylin’s Christian Weyer, the company’s vice president of corporate development for diabetes and obesity.

Data on the Amylin drug combo is still preliminary, but they are encouraging. The company looked at a variety of doses in a study of 608 overweight or obese patients, and has reported preliminary results after a little more than six months of observation. Patients on the highest doses, and who had body-mass indexes of less than 35, lost 11 percent of their body weight on the Amylin drug combo, compared with 1.8 percent average body weight loss in the placebo group.

There are caveats in the data. Patients who are more severely overweight, with a body-mass index of greater than 35, saw some benefit on the Amylin combo, but not as much … Next Page »

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