Santarus Begins Pivotal PK/PD Clinical Trial For ZEGERID -- Omeprazole -- Chewable Tablets.

SAN DIEGO -- Santarus, Inc. (Nasdaq:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that it has initiated a pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trial to evaluate ZEGERID(TM) Chewable Tablets 20mg, an immediate-release formulation of the proton pump inhibitor (PPI) omeprazole.

"This marks another milestone in our quest to bring a variety of immediate-release omeprazole products to physicians and their patients who are suffering from upper GI diseases and disorders related to gastric acid," said Gerald T. Proehl, president and chief executive officer of Santarus. "For ZEGERID Chewable Tablets, we are following the same regulatory strategy used to gain U.S. marketing approval for our first product, ZEGERID(TM) Powder for Oral Suspension. Earlier this week, we announced market launch for that product."

In addition to the newly initiated PK/PD trials to evaluate ZEGERID Chewable Tablets 20mg, Santarus is currently completing PK/PD trials with ZEGERID Capsules 20mg and 40mg. The company intends to file a new drug application (NDA) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking U.S. marketing approval for these formulations, based upon the successful completion of the PK/PD trials.

The primary objective of this newly initiated clinical trial is to evaluate whether the 20mg immediate-release ZEGERID (omeprazole) Chewable Tablets are pharmacokinetically equivalent to 20mg delayed-release omeprazole capsules with respect to total systemic bioavailability (AUC). The trial will also assess whether ZEGERID Chewable Tablets and the delayed-release omeprazole capsules have similar ability to suppress gastric acid over 24 hours.

Santarus plans to initiate a pivotal PK/PD clinical trial to evaluate ZEGERID Chewable Tablets in a 40mg dose strength later this year.

About Santarus

Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the prevention and treatment of gastrointestinal diseases and disorders. In October 2004, the company announced the commercial launch of its first product, ZEGERID Powder for Oral Suspension 20mg, following the receipt of marketing approval from the U.S. Food and Drug Administration (FDA) in June 2004. The company has an NDA under review by the FDA for ZEGERID Powder for Oral Suspension 40mg. The company also is developing capsule and chewable tablet formulations. The company's products are immediate-release formulations of omeprazole, a widely prescribed PPI. 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. These forward-looking statements include statements regarding the regulatory strategy for ZEGERID Chewable Tablets 20mg and Santarus' other products under development, the potential to obtain regulatory approval for any products under development, and the commercial prospects for ZEGERID Powder for Oral Suspension 20mg and any other products which may receive regulatory approval.

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: risks related to difficulties or delays in development, testing, manufacturing and marketing of, and obtaining regulatory approval for, Santarus' products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus' products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for Santarus' products; Santarus' ability to commercialize its products without infringing the patent rights of others; 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 the Private Securities Litigation Reform Act of 1995.

Santarus(R) and ZEGERID(TM) are trademarks of Santarus, Inc.