Santarus, Inc, a specialty biopharmaceutical company, has received the US$ 20 million milestone payment previously announced on December 1, 2009 relating to the approval of Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc, the consumer healthcare division of Merck & Co, Inc Schering-Plough and Merck merged on November 3, 2009.
The US Food and Drug Administration (US FDA) approved Schering-Plough HealthCare Products' New Drug Application (NDA) for Zegerid OTC for OTC treatment of frequent heartburn on December 1, 2009. The OTC heartburn market in the US is estimated at US$ 1.7 billion based on data from Information Resources, Inc, a market research firm, and company estimates. Zegerid OTC capsules are expected to be available on retail store shelves in the first half of 2010.
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 US$ 37.5 million in sales milestones. Santarus will also 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 under the license agreement. 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 20 mg and 40 mg dosage strengths of omeprazole in the US prescription market for PPI products. Approximately 96 per cent of Zegerid Capsules prescriptions are written for the 40 mg dosage strength. Prescription strength Zegerid is indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months), and for short-term treatment of active benign gastric ulcers and active duodenal ulcers.
Santarus is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians.