Santarus (SNTS) Reports December '09 Action Date for Schering-Plough's (SGP) OTC ZEGERID NDA
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Santarus, Inc. (NASDAQ: SNTS) today announced that Schering-Plough (NYSE: SGP) HealthCare Products, Inc. has received notification from the U.S. FDA of a December 2009 action date for an OTC ZEGERID(R) branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole.
Schering-Plough submitted a New Drug Application in March 2008 seeking approval to sell ZEGERID in the U.S. OTC heartburn market. OTC ZEGERID is being developed under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus' patented technology. Schering-Plough received a complete response letter for its OTC ZEGERID NDA in January 2009 and submitted a response to the FDA in early June 2009.
Under the license agreement with Schering-Plough, Santarus is entitled to receive a $20-million milestone upon FDA approval of OTC ZEGERID, a low double-digit royalty on net sales of any OTC ZEGERID product, and may receive up to an additional $37.5 million in sales milestones.
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