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
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
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is also an Inside Value recommendation and the Fool owns shares of the company. The Fool's disclosure policy is late to every staff meeting.