Schering-Plough HealthCare Products commences promotion of ZEGERID OTC in North America

Apr 2 2010

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc., the consumer healthcare subsidiary of Merck & Co., Inc., has commenced promotion of ZEGERID OTC^™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its licensing agreement with Santarus for the over-the-counter (OTC) market in North America. The OTC heartburn market in the U.S. is estimated at approximately $1.8 billion based on data from market research firm Information Resources, Inc. and Santarus estimates.

“The commercialization of ZEGERID OTC is in keeping with our strategy to maximize our patented PPI technology”

Under the terms of the ZEGERID OTC license agreement, Santarus is entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold in North America. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products. Santarus also may be entitled to receive up to an additional $37.5 million in sales milestones.

ZEGERID OTC is the only OTC proton pump inhibitor (PPI) product with two active ingredients, omeprazole, a PPI, and sodium bicarbonate. The sodium bicarbonate acts as a buffer to raise the gastric pH and protect the omeprazole from acid degradation in the stomach and allows it to be absorbed. ZEGERID OTC is a 14-day course of treatment taken once daily as directed to treat frequent heartburn, defined as heartburn that occurs two or more days a week. For more information about ZEGERID OTC, visit www.ZegeridOTC.com.

"The commercialization of ZEGERID OTC is in keeping with our strategy to maximize our patented PPI technology," said Gerald T. Proehl, president & chief executive officer of Santarus. "With its dual-ingredient formula, ZEGERID OTC offers an attractive alternative to the currently marketed OTC PPI products and positions us to receive royalty revenues without further investment from Santarus. Schering-Plough Consumer HealthCare began shipping ZEGERID OTC in late March, and we expect to report royalty revenue from these shipments in our first quarter financial results."

He added, "We expect the consumer advertising and publicity campaign associated with the launch of ZEGERID OTC to increase consumer and physician awareness of the ZEGERID brand. Santarus is working to capitalize on this anticipated increased awareness through a significant promotional campaign for our prescription products focused on approximately 45,000 physicians who prescribe PPI products but are not called on by our sales force. The new Santarus campaign includes journal advertising, teledetailing, direct mail and e-mail promotion, Internet outreach and the availability of product samples."

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 U.S. prescription market for PPI products. Approximately 97% 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 (4-8 weeks) 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 (4-8 weeks) of active benign gastric ulcers and active duodenal ulcers, and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg; use beyond 14 days has not been evaluated).