The little drugmakerdisclosed study results this morning indicating its experimental obesity pill doesn't appear to cause the kind of heart-valve damage that forced Wyeth to withdraw two diet pills - one-half of the fen-phen combo and a related pill, Redux - exactly a decade ago.
An independent safety-monitoring group recommended that a two-year trial of 3,100 patients continue after scans showed no increased risk of heart damage following six months on the pill, compared with a placebo. "It's an important milestone to help us understand the safety of our drug," Jack Lief, Arena's ceo, tells Bloomberg News. "If we had a fen-phen type of effect on the heart, we should see it by now."
Known as lorcaserin, the drug is designed to stimulate a protein in the brain that makes people feel full, while sparing a similar protein that caused fen-phen to damage heart valves. The difference is what Arena believes will separate its drug from the kind of problems that Wyeth faced. If one-year results are positive, Arena hopes to seek FDA approval in 2009. The overweight are starved for an effective diet pill. Only two prescription meds are currently available - Abbott's Meridia and Roche's Xenical, but they produce modest weight loss and undesirable side effects. Glaxo recently began peddling an over-the-counter version of Xenical called Alli. A drug from was Sanofi-Aventis, meanwhile, was rejected this year by the FDA.
Arena's Lief, meanwhile, says he's talking to plenty of drugmakers about marketing scenarios. Maybe Wyeth should get in line. If Arena's pill really does work without hurting hearts, perhaps Wyeth could eventually make enough money to compensate for the $21 billion in charges taken to pay for diet-pill litigation these past 10 years. What do you think, Bob?
pic thx to alan cleaver on flickr