FDA's Bipolar Decision on Schering's Drug

Schering-Plough's (NYSE: SGP) been waiting quite a while for a decision from the Food and Drug Administration about its schizophrenia and bipolar drug Saphris. Alas, this wasn't the decision it was looking for.

The slow-as-molasses-in-January agency turned down Schering's marketing application about 14 months after it was turned in. That's the bad news.

The good news is that Schering says the FDA included proposed labeling with the rejection letter. The agency generally starts working on the label after it has decided to approve the drug -- otherwise, it would just be a waste of time. It appears the FDA just needs some additional information from Schering before it can slap an approval on the drug, but further clinical trials won't be necessary.

Schering obtained Saphris in its acquisition of Organon BioSciences. The company got a pretty well-stocked late-stage pipeline in the deal, but it hasn't had the best luck getting those drugs approved. First, Bridion, an anesthesia reversal agent, got turned down by the FDA. Now Saphris will be delayed at least a little longer.

It's difficult to guess Saphris's sales potential once it does make it to market. The drug has fared well in head-to-head trials against Eli Lilly's (NYSE: LLY) Zyprexa, Johnson & Johnson's (NYSE: JNJ) Risperdal, showing comparable efficacy with fewer side effects. And in a safety test comparing to AstraZeneca's (NYSE: AZN) Seroquel, heart rhythm issues were not a problem. But few doctors are likely to switch stably medicated psychotic patients to new drugs -- that would just be crazy. And with Risperdal now available as a generic, it may get preferentially prescribed for newly diagnosed patients. The crowded market is likely the reason that Pfizer (NYSE: PFE) discontinued its Saphris development partnership with Organon in 2006.

Even if Saphris turns out to be a marketing dud, Schering should be O.K. It still has a well-stocked pipeline with multiple shots on goal. All it needs is one more blockbuster to make up for the languishing sales from its cholesterol drug partnership with Merck (NYSE: MRK). After that, anything else should be icing on the cake.

We prescribe further Foolishness:

• The FDA needs a bake sale to pay for faster service.
• The agency helped out Merck and Schering, but it was a little late.
• Will large-cap value break out in 2009?