Santarus Announces Positive Results from Pivotal PK/PD Clinical Trials

    Business Editors/Health/Medical Writers

    SAN DIEGO--(BUSINESS WIRE)--Feb. 9, 2005--Santarus, Inc. (Nasdaq:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that the primary objectives were met in its pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trials evaluating ZEGERID(TM) (omeprazole) Chewable Tablets 20 mg and 40 mg. Following final analysis of the clinical trial data and collection and analysis of the stability data, the company plans to file a new drug application (NDA) under Section 505(b)(2) of the Federal, Food, Drug, and Cosmetic Act with the U.S. Food and Drug Administration (FDA) during the second half of 2005, seeking U.S. marketing approval for ZEGERID Chewable Tablets. The ZEGERID products are immediate-release formulations of the proton pump inhibitor (PPI) omeprazole.
    In October 2004, Santarus launched ZEGERID (omeprazole) Powder for Oral Suspension 20 mg, which received FDA approval in June 2004. The company received FDA approval of ZEGERID (omeprazole) Powder for Oral Suspension 40 mg in December 2004 and is planning to launch the 40 mg product later in the first quarter of 2005. Santarus announced positive results from pivotal PK/PD clinical trials for ZEGERID (omeprazole) Capsules 20 mg and 40 mg in November 2004 and plans to file an NDA for the 20 mg and 40 mg Capsules in the third quarter of 2005.
    "Throughout the past year, we have continued to successfully achieve our clinical development and regulatory milestones. We received two NDA approvals in 2004 for ZEGERID Powder for Oral Suspension and completed pivotal trials on ZEGERID Capsules 20 mg and 40 mg. With the completion of our pivotal trials for ZEGERID Chewable Tablets 20 mg and 40 mg, we are able to move a third product closer to commercialization," said Gerald T. Proehl, president and chief executive officer of Santarus. "We are very pleased with the continued progress of our ZEGERID family of products."

    Preliminary Data from ZEGERID Chewable Tablets Trials

    The pivotal PK/PD clinical trials evaluating ZEGERID Chewable Tablets 20 mg and 40 mg were open-label, randomized, crossover trials, each conducted at a single site. Each trial evaluated the pharmacokinetics and pharmacodynamics of single doses and seven consecutive daily doses of ZEGERID Chewable Tablets compared to delayed-release omeprazole capsules in 36 healthy subjects. The primary objective of the trials was to evaluate whether the immediate-release ZEGERID Chewable Tablets were pharmacokinetically equivalent to delayed-release omeprazole capsules with respect to total systemic bioavailability (AUC) on Day 7. The trials also assessed whether ZEGERID Chewable Tablets and the delayed-release omeprazole capsules had similar ability to suppress gastric acidity over 24 hours. The preliminary trial results demonstrated that ZEGERID Chewable Tablets and the delayed-release omeprazole capsules were statistically equivalent with respect to AUC and percent decrease from baseline in integrated gastric acidity on Day 7.
    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 Day 7 for ZEGERID Chewable Tablets 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 20 mg and 40 mg and ZEGERID Capsules 20 mg and 40 mg.

    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 received FDA approval to market ZEGERID Powder for Oral Suspension 40 mg in December 2004. The company also is developing capsule and chewable tablet formulations of ZEGERID. 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 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: Santarus' ability to timely file NDAs and obtain regulatory approval for ZEGERID Capsules and Chewable Tablets; 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.

--30--JC/la*

CONTACT: Santarus, Inc. Martha L. Hough, 858-314-5824 Debra P. Crawford, 858-314-5708 or Lippert/Heilshorn & Associates (Investor Contact) Jody Cain / Bruce Voss, 310-691-7100 jcain@lhai.com / bvoss@lhai.com

KEYWORD: CALIFORNIA INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL PRODUCT SOURCE: Santarus, Inc.

Copyright Business Wire 2005