Santarus announces Schering-Plough response submission to FDA for OTC Zegerid

NEW YORK There was speculation in January that Schering-Plough’s switch application around the proton-pump inhibitor Zegerid was scuttled after receiving a complete response letter from the Food and Drug Administration.

That speculation was based on two factors —  the FDA obviously had additional questions around the switch application, but the general public really had no inclination as to which direction the FDA was leaning on the matter. (That’s because “complete response letters” replaced FDA’s “approvable” and “not approvable” letters.) So some analysts assumed the worst.

Now there is new speculation (at least here in the hallways of Drug Store News), that the Zegerid PPI will be approved by the PDUFA date of December, based entirely on the fact that Schering Plough addressed those FDA concerns within six months.

If that speculation should prove out, it will mark the second PPI to hit the market this year after Novartis’ Prevacid 24HR in the summer, and the first PPI formulation that combines omeprazole with something else — that something else being sodium bicarbonate, an antacid that affords Santarus the prescription marketing claim that Zegerid is the “first and only” immediate-release PPI on the market.

It also will mark a very interesting and volatile year for marketers of all heartburn remedies. The antacid tablet category was slightly down 1.3%, according to Information Resources Inc. data for the 52 weeks ended April 19 for food drug and mass (excluding Walmart), thanks in large part to the introduction of store-brand omeprazole. But now with the introduction of Novartis and Schering Plough to the PPI offering mix, the category likely will be significantly up from its present $1.1 billion sales base — up by as much as 15%.

And that’s an even safer speculation than the Zegerid approval in December. Last year, McNeil Consumer’s launch of Zyrtec generated close  to $300 million across its top two SKUs, according to IRI data for the same period, while Schering-Plough’s top three Claritin SKUs lost little more than $20 million in dollar volume, suggesting that Zyrtec scored plenty of consumers outside of converting one-time, loyal Claritin users (the other two big dollar-volume “losers” last year — McNeil’s own Benadryl and Airborne.) Zyrtec was the second second-generation antihistamine to reach the market, so it is similar to Prevacid 24HR in that respect.

But more compelling is the number of massive marketers who all will be looking to protect/grow their shares of stomach, starting with Procter & Gamble (Prilosec OTC), Boehringer Ingelheim (Zantac), McNeil Consumer (Pepcid and Rolaids), Novartis Consumer (Prevacid 24 HR launch and Gas X), GlaxoSmithKline (Tums and Tagamet) and now Schering-Plough with a Zegerid launch.