Santarus, Inc., a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, announced that its license agreement with Schering-Plough HealthCare Products, Inc. for the development, manufacturing and commercialization of Zegerid brand products for the over-the-counter (OTC) market is now effective, following the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Santarus expects to receive the $15 million upfront license fee payable under the OTC license agreement on November 22, 2006.
Under the terms of the OTC agreement, Schering-Plough will be responsible for the development, manufacturing and commercialization of OTC Zegerid products with the lower dosage strength of 20 mg of omeprazole for heartburn-related indications. Santarus will continue to manufacture, promote and sell Zegerid products in both 40 mg and 20 mg dosage strengths of omeprazole for their approved prescription indications in the US prescription market for proton pump inhibitor (PPI) products.
In addition to the $15 million upfront license fee, Santarus may receive up to an additional $65 million in milestone payments upon the achievement of certain regulatory and sales milestones. Santarus will also receive a royalty, subject to adjustment in certain circumstances, on net sales of any Zegerid OTC products sold by Schering-Plough under the license agreement. Santarus will be obligated to pay to the University of Missouri a royalty based on any Zegerid OTC net sales pursuant to a license agreement between Santarus and the University of Missouri.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients. The company currently markets Zegerid Capsules (launched in late March 2006) and Zegerid Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI.