Healthcare Industry News:  ZEGERID 

Biopharmaceuticals Gastroenterology

 News Release - January 23, 2006

Santarus Announces Publication of Peer-Reviewed Journal Articles on ZEGERID in Treating Upper GI Diseases and Disorders

SAN DIEGO--(HSMN NewsFeed)--Jan. 23, 2006--Santarus, Inc. (NASDAQ:SNTS ), a specialty pharmaceutical company focused on therapies for gastrointestinal (GI) diseases and disorders, today announced the publication of three articles in peer-reviewed journals, which include reviews and discussions of the company's ZEGERID® Powder for Oral Suspension product, an immediate-release formulation of omeprazole, a proton pump inhibitor (PPI). In addition, the proceedings of a Santarus-sponsored roundtable were published in a supplement to a peer-reviewed gastroenterology journal.

The three recently published journal articles are:
  • "Review of Immediate-Release Omeprazole for the Treatment of Gastric Acid-Related Disorders," which was published in the November 2005 issue of Expert Opinion on Pharmacotherapy. ZEGERID Powder for Oral Suspension was reviewed by Donald Castell, MD, Professor of Medicine and Director, Esophageal Disorders Program at the Medical University of South Carolina, past president of the American Gastroenterological Association and a member of the Santarus Medical Advisory Board.
  • "Nocturnal Reflux: Assessing and Addressing the Problem," which was published in the December 2005 issue of Practical Gastroenterology. This article is part of the series "GERD in the 21st Century" and was written by Philip O. Katz, MD, Chairman, Division of Gastroenterology, Albert Einstein Medical Center. It includes a discussion of ZEGERID Powder for Oral Suspension in controlling nighttime acidity.
  • "Advances in Proton Pump Inhibitor Therapy: An Immediate-Release Formulation of Omeprazole," which was published in Pharmacy & Therapeutics, December 2005. The article was written by Ralph E. Small, Pharm.D., Professor Emeritus, Virginia Commonwealth University.
The proceedings of the roundtable discussions were published as a supplement to the December 2005 issue of Alimentary Pharmacology and Therapeutics. Nine articles were authored by 11 key opinion leaders in gastroenterology and cover a wide range of topics in the management of gastroesophageal reflux disease (GERD) and upper GI bleeding in the critical care setting. The supplement is titled "Clinical Implications of Immediate-Release PPI Therapy in the Management of GERD and Upper GI Bleeding." A review of ZEGERID Powder for Oral Suspension clinical data is presented in five of the supplement articles.


PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. The immediate-release formulation of ZEGERID Powder for Oral Suspension produces rapid and sustained control of gastric acidity when administered once daily. Unlike delayed-release PPIs, ZEGERID Powder for Oral Suspension utilizes sodium bicarbonate in lieu of an enteric coating to protect the active ingredient from gastric acid degradation. The sodium bicarbonate buffers the active ingredient, omeprazole, and facilitates its rapid absorption and suppression of gastric acid.

ZEGERID Powder for Oral Suspension 20 mg is indicated for heartburn and other symptoms associated with GERD, for the short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months) and for the short-term treatment (four to eight weeks) of active duodenal ulcer. ZEGERID Powder for Oral Suspension 40 mg is indicated for the short-term treatment (four to eight weeks) of active benign gastric ulcer and for reduction of risk of upper GI bleeding in critically ill patients (use beyond 14 days has not been evaluated).

The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients and were similar for patients treated with ZEGERID and with the comparator (acid controlling) drug. 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 contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq) which 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.

About Santarus

Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products to enhance the quality of life for patients with gastrointestinal diseases and disorders. The company's current products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company launched its first product, ZEGERID Powder for Oral Suspension 20 mg, in October 2004 and launched ZEGERID Powder for Oral Suspension 40 mg in February 2005. The company submitted a New Drug Application (NDA) for ZEGERID Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA) in April 2005 and submitted an NDA for ZEGERID Chewable Tablets 40 mg and 20 mg to the FDA in May 2005. More information about Santarus is available on the company's Web site at

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 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: unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID Powder for Oral Suspension or Santarus' other products under development that could delay or prevent product commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval 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® and ZEGERID® are trademarks of Santarus, Inc.

Source: Santarus

Issuer of this News Release is solely responsible for its content.
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