Arena Pharmaceuticals can breathe a sigh of relief. Twelve years of work and $1 billion invested in drug development isn’t going down the drain. The San Diego-based company is reporting today that it has passed the second big clinical trial it needs to win FDA approval to sell an obesity drug that has potential to be used by millions of people, and which could generate billions in sales.
The long-awaited results from Arena (NASDAQ: ARNA) from a trial of 4,008 patients essentially confirm what the company found in a previous study of 3,182 patients back in March. The drug met at least one of the FDA’s benchmarks for effectiveness as an obesity treatment and was found to be safe and well-tolerated. Arena plans to present all the nitty-gritty details next month at The Obesity Society meeting in Washington D.C., and plans to ship off an application to the FDA by the end of this year.
“We’re excited. We’ve accomplished what we set out to accomplish,” says Jack Lief, Arena’s CEO.
Obesity is one of the nation’s biggest public health problems, with two-thirds of the U.S. population considered overweight. As I described in a story Monday, drug companies know the winner in this category might dominate the biggest pharmaceutical market ever. In our couch-loving, junk-food eating culture, health officials say obesity often leads to diabetes and a raft of other costly health problems. Yet Big Pharma has been gun shy about this market opportunity since Wyeth was burned by the multi-billion legal payments related to the heart damage that patients suffered from the fen-phen drug in the 1990s. Two years ago Sanofi-Aventis failed to win approval for an obesity drug that was linked to rare cases of suicidal thinking. If any of the new contenders can assure the FDA their drug is truly safe, obesity drugs will again become a popular culture phenomenon, and will likely get pitched as a pre-emptive cure-all for illnesses related to obesity—like diabetes, high blood pressure, high cholesterol, and depression.
Although Big Pharma has been cautious, Arena and other biotechs are in hot pursuit of the market. San Diego-based Orexigen Therapeutics (NASDAQ: OREX), Mountain View, CA-based Vivus (NASDAQ: VVUS), and San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN) have all shown encouraging results from mid-or-late stage clinical trials. Vivus and Arena appear to be ahead in the race, with stated goals of sending their applications to the FDA by the end of this year. Orexigen plans to turn in its FDA filing in the first half of 2010, while Amylin is still in mid-stage clinical trials.
So what did Arena really learn from this huge clinical trial coming out today, known as Blossom?
Patients in the Blossom study were followed for one year after they were randomly assigned to get either a twice-daily pill, a once-daily pill, or a placebo. Patients on the twice-daily Arena treatment lost the most weight—an average of 5.9 percent of their body weight, compared with 2.8 percent on placebo. That finding, by itself, isn’t good enough to pass muster with the FDA, because it typically wants … Next Page »