San Diego-based Arena Pharmaceuticals has spent a dozen years, and raised almost $1 billion from investors and partners, to create a new drug that helps millions of people lose weight. This month, the company will find out whether the time and money was well spent.
Arena (NASDAQ: ARNA) plans to unveil results of a 4,008-patient clinical trial in September that will answer vital questions about its experimental pill, lorcaserin. The study, called Blossom, is designed to see whether a high or low dose of the treatment can help patients lose weight over a full year compared to a placebo. The study will also look at whether the Arena drug helps with many ailments that stem from obesity—high blood pressure, cholesterol, high blood sugar, and inflammation, to name a few.
If this clinical trial confirms the findings of another major trial from earlier this year, Arena will bundle the data together and ship it to the FDA by the end of this year for approval to start selling lorcaserin in the U.S. Arena will have a very busy fall, as the results are scheduled for a full presentation at The Obesity Society’s scientific meeting in October. If the results withstand all that public scrutiny, the company hopes to entice a Big Pharma company with the muscle to put together a mass marketing campaign aimed at the roughly two-thirds of people in the U.S. who are considered overweight or obese.
“It’s an exciting time,” says Arena CEO Jack Lief. “It’s been a long time. I can’t wait.”
Any drug for obesity has to have a squeaky clean safety profile because it would potentially be taken by millions of people without an imminently life-threatening condition like cancer.
While the bar is high, obesity represents a potentially gigantic market. The leading treatment on the market is a four-decade old generic amphetamine, called phentermine, that most people avoid because it causes insomnia and high blood pressure.
Arena really has not taken any interim peeks at the clinical trial results while the study is ongoing, so it will have a motherlode of raw data to sift through for the first time. When I spoke with Lief and Arena’s chief scientific officer, Dominic Behan, last week, they were optimistic as usual that this study would confirm the safety and effectiveness they saw earlier this year in the 3,182-patient clinical trial known as Bloom. “We don’t expect any bad stuff to come out, because Bloom was so robust,” Lief says.
Based on those results, and assuming that Blossom provides the added confirmation the FDA wants to see, Arena has clearly been sharpening up its marketing strategy and competitive position against rival treatments from San Diego-based Orexigen Therapeutics (NASDAQ: OREX) and Mountain View, CA-based Vivus (NASDAQ: VVUS).
Both Arena and Orexigen underwhelmed investors … Next Page »
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