SAN DIEGO--(BUSINESS WIRE)-- Santarus, Inc., a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc. has received notification from the U.S. Food and Drug Administration (FDA) of a December 2009 action date for an over-the-counter (OTC) ZEGERID® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole.
Schering-Plough submitted a New Drug Application (NDA) in March 2008 seeking approval to sell ZEGERID in the U.S. OTC heartburn market. OTC ZEGERID is being developed under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ patented technology. Schering-Plough received a complete response letter for its OTC ZEGERID NDA in January 2009 and submitted a response to the FDA in early June 2009. Under the license agreement with Schering-Plough, Santarus is entitled to receive a $20-million milestone upon FDA approval of OTC ZEGERID, a low double-digit royalty on net sales of any OTC ZEGERID product, and may receive up to an additional $37.5 million in sales milestones.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other targeted physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension, which are indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. More information about Santarus is available on the company’s Web site at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Such forward-looking statements include, but are not limited to, statements about potential timing for FDA response and potential future milestones and royalties related to the OTC license with Schering-Plough. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: whether the FDA responds to Schering-Plough’s response submission in a timely manner; whether the FDA ultimately approves the Schering-Plough NDA in a timely manner or at all; whether, subject to receipt of FDA approval, Schering-Plough is able to generate market demand and acceptance for OTC ZEGERID and, in turn, generate sales milestones and royalty payments for Santarus; Schering-Plough’s level of commitment, the potential for termination of the licensing arrangement and other risks related to the licensing arrangement; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Santarus® and ZEGERID® are registered trademarks of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX® is a registered trademark of Cosmo Technologies Limited.
