Schering-Plough (NYSE: SGP ) must have held its breath or had someone scare it right before it went into its FDA panel hearing yesterday. The hiccups that I postulated Schering might face during the meeting never really materialized.
In fact, the panel voted unanimously to recommend that the FDA approve Bridion, Schering's drug used to reverse the effects of muscle blocks during surgery. The panel said that the drug could be used in all the situations that Schering had requested, including emergencies where patients need to be revived quickly. On the safety front, the panel recommended post-marketing studies to make sure that the minor problems seen in the clinical trials actually are minor. Overall, the results of the panel's meeting were the best Schering could have hoped for.
The FDA doesn't always follow a panel's recommendation -- think Genentech (NYSE: DNA ) last month -- but, given the relatively positive executive summary the FDA presented to the panel, an approval seems likely in this case.
The only question now is how well Schering will be able to market the drug. Bridion works much better than drugs made by generic-drug makers Novartis (NYSE: NVS ) , Baxter (NYSE: BAX ) , and Hospira (NYSE: HSP ) , but it's unclear whether the quicker recovery time will justify the higher price tag. In many patients, no drug is used, and the body clears the muscle block naturally, so quicker clearly isn't necessarily better for all patients.
Schering needs Bridion to succeed, not only to justify its $14 billion acquisition of the Organon BioSciences unit of Akzo Nobel (Nasdaq: AKZOY ) , which developed the drug, but also because Schering needs to replace the growth lost in its cholesterol drug partnership with Merck (NYSE: MRK ) , after a post-marketing study suggested that drug might not work as well as the duo hoped.
Fortunately, Schering has a well-stocked pipeline, so if Bridion doesn't live up to its potential, the drugmaker has other drugs right behind it.