Zegerid on track
This article was originally published in The Tan Sheet
Executive Summary
Santarus reports FDA "is moving along" on its review of an Rx-to-OTC switch application for Zegerid, the firm's immediate-release proton pump inhibitor/antacid product. Schering-Plough filed an application in March for the omeprazole/sodium bicarbonate heartburn drug under a licensing agreement with the San Diego-based firm (1"The Tan Sheet" March 17, 2008, In Brief). Santarus says it is hopeful for approval "somewhere around" early January, CEO Gerald Proehl said during a Nov. 3 quarterly earnings call. If approved, the product will compete with Procter & Gamble's Prilosec OTC, generic omeprazole and other heartburn treatments. Quicker onset claims could give Zegerid an edge over other omeprazole products. For the third quarter ended Sept. 30, prescription Zegerid sales were up 44 percent to $28.1 million. Santarus total revenue was $32.2 million, including a $5 million milestone payment from Schering-Plough. Net loss was $4 million compared with $6.9 million in the prior-year period. The firm adjusted its guidance, projecting a net loss for the year below $8.4 million, down from below $12.5 million
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