Zegerid OTC Looks To Burn Up The PPI Market in 2010

 

With the Dec. 1 FDA approval of Zegerid OTC, effective positioning becomes even more important within the OTC proton pump inhibitor market. The Merck/Schering-Plough product, licensed from Santarus, will be the first of three branded drugs to feature a dual-ingredient formulation, as we report here in today's "Health News Daily."

Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg) is slated to launch in the first half of 2010 and could pose a strong threat to Procter & Gamble's Prilosec OTC (omeprazole 20 mg) and Novartis' just-launched Prevacid 24HR (lansoprazole 15 mg). The Zegerid OTC Web site, essentially a placeholder at present, plays up the drug's "special ingredient" (sodium bicarbonate), which "protects the omeprazole from acid in the stomach," it claims.

While this marketing tack could provide a valuable edge, Zegerid OTC does not appear to claim "immediate release" or any other degree of faster onset than the PPI competition. P&G petitioned FDA early in 2009 to preclude the possibility of Zegerid making a claim of shorter "time to full effect" than Prilosec OTC, as we reported here. PPIs typically take one or more days to provide full effect.

FDA denied P&G's petition but there is no indication thus far that the agency allowed any faster onset claim for Zegerid OTC. The product's Web site, which at the moment shows only a front-of-package image and not the full drug information, says Zegerid OTC suppresses stomach acid "for a full 24 hours, all day and all night" -- also comparable to claims made for Prilosec OTC and Prevacid 24HR.

In addition to benefiting heartburn sufferers, the Zegerid OTC launch will likely prove a boon for both its sponsor and originator. In March, we reported on how the Schering-Plough acquisition would bolster Merck's consumer health portfolio and diversify its revenue streams.

As for Santarus, the approval means a $20 million milestone payment that goes right to the firm's bottom line, with the potential for $37.5 million more from sales milestones. Dow Jones this morning pointed to the jump in Santarus' stock price following Zegerid's approval. Additionally, as we recently noted here, Santarus expects Merck's marketing of the OTC version to grow awareness of Rx Zegerid among health care providers.

Read more about Zegerid OTC and the world of Rx-to-OTC switches in "The Tan Sheet." Click here to subscribe or to start your free 30-day trial.

- Dan Schiff (d.schiff@elsevier.com)