Sanofi's bid for more OTC meds gets FDA boost

Sanofi CEO Christopher Viehbacher

Sanofi ($SNY) may soon have another allergy drug to add to its over-the-counter stable. FDA reviewers backed Nasacort AQ as safe for use without a prescription, Reuters reports, ahead of an advisory panel meeting Wednesday.

If approved, Nasacort would further beef up the consumer healthcare business Sanofi has been expanding over the past several years as it diversified ahead of the patent cliff. Approved or not, the advisory panel meeting should offer some more clues to other Big Pharma companies hoping to convert formerly big-selling prescription drugs to over-the-counter status.

With peak sales of $375 million, Nasacort wasn't the champion that Allegra was. Nor does it bring in nearly as much, on the prescription side, as Allegra continues to, even with generic competition. The prescription version of Nasacort accounted for €71 million (about $94 million) last year, down from €189 million in 2010. Prescription Allegra, on the other hand, racked up 2012 sales of €553 million, down from €580 million in 2011.

But launching Nasacort over the counter would give Sanofi another opportunity to turn the product into sales. Rolled out in March 2011, Allegra OTC generated €211 million ($280 million) that year, Sanofi says. The product's sales are accounted for under Sanofi's consumer health business now, which didn't report Allegra separately in the 2012 annual report.

The consumer health unit remains one of Sanofi CEO Christopher Viehbacher's growth projects. Since Viehbacher took over at the French drugmaker, he has engineered a series of deals designed to strengthen consumer healthcare sales, as a cushion against patent expirations on the prescription side and a channel for growth in emerging markets. In fact, it bought U.S.-based Chattem in 2009 for $1.9 billion to gain access to that company's U.S. infrastructure in anticipation of an Allegra OTC launch.

It's that infrastructure that would deliver Nasacort to customers as well. A corticosteroid nasal spray used to fight hay fever and other respiratory allergies, Nasacort AQ would be the first of its kind to be sold over the counter in the U.S. "We believe that a first-in-class OTC nasal spray has the potential to achieve significant market share during its launch year and beyond," Sanofi spokesman Jack Cox told Reuters.

Sanofi isn't the only major drugmaker looking to over-the-counter sales of its prescription products. The FDA hasn't always cooperated--consider Merck's ($MRK) failure to win OTC status for its statin drug Mevacor in 2007--but the agency appears to be more open to moving a variety of prescription meds over the counter. That would open up access to consumers and save government programs money they would otherwise shell out for prescriptions.

- see the Reuters news

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