Santarus has received the $20m milestone payment previously announced on December 1, 2009 relating to the approval of Zegerid OTC (omeprazole 20mg/sodium bicarbonate 1100mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, the consumer healthcare division of Merck & Co.
The FDA has approved Schering-Plough HealthCare Products’ New Drug Application (NDA) for Zegerid OTC for treatment of frequent heartburn, on December 1, 2009. Zegerid OTC capsules are expected to be available on retail store shelves in the first half of 2010.
Reportedly, the NDA was submitted by Schering-Plough HealthCare Products under the terms of a license agreement for OTC proton pump inhibitor (PPI) products, using Santarus’ proprietary technology. Santarus may be entitled to receive up to an additional $37.5m in sales milestones.
Additionally, Santarus is also expected to be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any Zegerid OTC products sold by Schering-Plough HealthCare Products. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.
Santarus is continuing to manufacture, promote and sell its Zegerid (omeprazole/sodium bicarbonate) prescription products in both 20mg and 40mg dosage strengths of omeprazole in the US prescription market for PPI products.