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. 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). Important Safety Information about Prescription Strength ZEGERID Capsules and Powder for Oral Suspension The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information at www.Zegerid.com. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet.
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet. For more information about prescription strength ZEGERID, please visit www.Zegerid.com. 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, endocrinologists and other physicians. The company’s current commercial efforts are focused on ZEGERID ® (omeprazole/sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA ® (metformin hydrochloride extended release tablets), which is 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 a Phase III clinical program for the induction of remission of mild or moderate active ulcerative colitis. Santarus expects to begin Phase III clinical testing of rifamycin SV MMX in patients with travelers’ diarrhea in the second quarter of 2010. 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. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives 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 Schering-Plough HealthCare Products is able to generate market demand and acceptance for ZEGERID OTC and, in turn, generate sales milestones and royalty payments for Santarus; Schering-Plough HealthCare Product’s level of commitment, the potential for termination of the OTC licensing arrangement and other risks related to the licensing arrangement; the scope and validity of patent protection for ZEGERID products, including the timing and outcome of the patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus’ and its strategic partners’ ability to commercialize products without infringing the patent rights of others; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; 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 ® , ZEGERID ® and ZEGERID OTC ™ are 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.