Schering Plough files NDA for Zegerid OTC heartburn treatment

KENILWORTH, N.J. Schering-Plough has submitted a new drug application to the Food and Drug Administration for an over-the-counter branded version of its prescription heartburn treatment drug Zegerid.

The application was submitted due to a license agreement between Schering and Santarus, which was signed in October 2006. The agreement grants the right to market the OTC Zegerid product using Santarus’ patented technology.

Under the agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and commercialization of Zegerid OTC products for heartburn-related indications in the United States and Canada. Santarus continues to manufacture, promote and sell its Zegerid prescription products in both 20 mg and 40 mg strengths for the proton pump inhibitor market.

"Schering-Plough is looking forward to working with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn," said John O'Mullane, group vice president of research and development at Schering-Plough Consumer Health Care. "When approved, Zegerid will be a valuable addition to our expanding portfolio of gastrointestinal OTC products, such as Miralax, which was launched last year for the treatment of occasional constipation."

Santarus is entitled to receive up to $22.5 million in regulatory milestones and up to $37.5 million in sales milestones. Schering-Plough previously had paid Santarus a $15 million upfront license fee, and a $5 million milestone payment.