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We often refer to drug development as a marathon because of the long road it takes to get a drug through clinical trials and the regulatory process. Orexigen (Nasdaq: OREX ) seemed to be in a perfect position to win the race, having passed the obesity drug leaders -- VIVUS (Nasdaq: VVUS ) and Arena Pharmaceuticals (Nasdaq: ARNA ) -- and used their experience to gain positive Food and Drug Administration advisory panel results.
And then it bonked, a term marathoners use for hitting the wall. Down 70%, it's just sitting there paralyzed.
The FDA is requiring Orexigen to run a trial measuring cardiovascular events in patients taking its obesity drug, Contrave, before it can be approved. Investors were hoping that the agency would follow the FDA panel's 11-8 recommendation to allow the company to run the trial after the approval.
The FDA's move doesn't shock me. As I said when the FDA's experts voted, many seemed to want a pre-approval trial but didn't think that moving the goalposts on the company was fair. The FDA cares a lot more about safety than it does fairness.
How long are we talking? It's still too early to tell. Management needs to meet with the FDA to see exactly how large a trial should be and for how long the agency wants it to follow patients.
The Scout trial measuring cardiovascular events in patients taking Abbott Labs' (NYSE: ABT ) Meridia took seven years to read out data. Of course, Meridia was already on the market, so Abbott had more to lose by completing the trial than by dragging it out. Presumably, Orexigen can do it in less time, but we're still talking years.
Orexigen's best move might be to climb on a stretcher and head home to start training for the next marathon. The drugmaker has a second-generation obesity drug called Empatic, which also contains bupropion, the active ingredient in GlaxoSmithKline's (NYSE: GSK ) Wellbutrin and the suspected culprit for the potential heart issues in Contrave. Empatic appears to work better than Contrave in early trials, and if Orexigen is going to have to run outcomes studies for both drugs separately, it seems like a waste of money to run them on Contrave, only to have Empatic cannibalize sales fairly soon after approval.
I know Orexigen looks tempting at the beaten-down levels, but investors would be wise to wait until the company picks itself up off the pavement and tells investors exactly which path it plans to run down next.
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