Zegerid Switch Progress Generates Bottom Line Help For Santarus
This article was originally published in The Tan Sheet
Executive Summary
Santarus' OTC licensing of its Zegerid Rx heartburn remedy to Schering-Plough has yet to pay dividends for S-P, but the deal is already helping Santarus reduce its net loss
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Santarus expects more Zegerid approvals
Other markets will approve the proton pump inhibitor in 2010, predicts Santarus CEO Gerald Proehl. "We may start to see some modest royalties in the last part of 2010 and into 2011" from GlaxoSmithKline, Proehl said Dec. 15 at the Lippert/Heilshorn Life Sciences Virtual Conference. GSK licenses Zegerid (omeprazole/sodium bicarbonate) in 114 countries in Africa, Asia, the Middle East and Central and South America (1"The Tan Sheet" June 2, 2008). Santarus licensed Rx and OTC Zegerid in Europe to U.K. pharma Norgine in October. Proehl said he also anticipates sales milestone payments as Merck/Schering-Plough introduces Zegerid OTC in U.S. in the first half of 2010 (2"The Tan Sheet" Dec. 7, 2009)
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Procter & Gamble is asking FDA to develop class labeling for OTC proton pump inhibitors that would effectively preclude all products in the category from claiming greater efficacy than P&G's Prilosec OTC
Schering-Plough’s Zegerid Switch Stumbles As FDA Questions Application
FDA indicated to Schering-Plough that the firm's Rx-to-OTC switch application for the proton pump inhibitor Zegerid is not ready for approval