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Zegerid

Generic name: omeprazole and sodium bicarbonate
Treatment for: Duodenal Ulcer, GERD, Stomach Ulcer, Erosive Esophagitis

Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target

SAN DIEGO, April 28, 2005 - Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that it has submitted a New Drug Application (NDA) for Zegerid (omeprazole) Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA). The Company is seeking marketing approval of Zegerid Capsules as the first immediate-release proton pump inhibitor (PPI) in a capsule formulation for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers. The company is currently marketing Zegerid Powder for Oral Suspension 40 mg and 20 mg, which is also an immediate-release PPI product and provides rapid absorption of the drug (reaching peak plasma levels in approximately 30 minutes) and strong 24-hour acid control with once-a-day dosing.

"Completing the Zegerid Capsules 40 mg and 20 mg NDA submission ahead of our previously announced third quarter target reflects our commitment to expanding the Zegerid product family and making immediate-release solid dosage PPI products available for physicians and patients. We believe the commercial availability of our capsule product will broaden Zegerid usage, as capsules may be more convenient for patients taking Zegerid on a chronic basis," said Gerald T. Proehl, president and chief executive officer of Santarus. "We continue to move forward on the Zegerid Chewable Tablets NDA submission, which we expect to complete in the third quarter of this year, bringing both our capsule and chewable tablet products closer to commercialization in the $12 billion U.S. PPI prescription market."

The NDA for Zegerid Capsules includes data from two pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trials, one for the 40 mg capsule and one for the 20 mg capsule, which were completed in November 2004. The trials were open-label, randomized, crossover trials, each conducted at a single site. Each trial evaluated the PK/PD profiles of Zegerid Capsules and delayed-release omeprazole capsules in an equivalent dosage strength in 36 healthy subjects. The primary objective of the trials was to evaluate whether the immediate-release Zegerid Capsules were pharmacokinetically equivalent to delayed-release omeprazole capsules with respect to total systemic bioavailability (AUC) on trial day 7. The trials also assessed whether Zegerid Capsules and the delayed-release omeprazole capsules had similar ability to suppress gastric acidity over 24 hours. The trial results demonstrated that Zegerid Capsules and the delayed-release omeprazole capsules were statistically equivalent with respect to AUC and percent decrease from baseline in gastric acidity on trial day 7. The safety profile of Zegerid Capsules was similar to that of delayed-release omeprazole capsules.

As expected for an immediate-release product, the maximum plasma concentration (Cmax) was greater and the time to maximum plasma concentration (Tmax) was shorter on trial day 7 for Zegerid Capsules than for the delayed-release omeprazole capsules. These results are similar to those obtained in the pivotal PK/PD trials that were conducted for Zegerid Powder for Oral Suspension 40 mg and 20 mg. Zegerid Powder for Oral Suspension 20 mg received FDA approval in June 2004, and the 40 mg formulation was approved in December 2004.

The NDA for Zegerid Capsules was submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act which allows an alternative path for FDA approval of new or improved formulations of previously approved products. If the NDA is accepted for filing by the FDA, Santarus will provide notice to the NDA holder for Prilosec delayed-release omeprazole capsules and related patent holders that Zegerid Capsules 40 mg and 20 mg do not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.

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