PPI
NDA Filed for Omeprazole Chewable Tablets
By Santarus, Inc.
May 27, 2005, 17:46

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(R) (omeprazole) Chewable Tablets 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA).

The Company is seeking marketing approval of ZEGERID Chewable Tablets as the first immediate-release proton pump inhibitor (PPI) in a chewable tablet 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. ZEGERID Powder for Oral Suspension is rapidly absorbed (reaching peak plasma levels in approximately 30 minutes) and has strong 24-hour acid control with once-a-day dosing.

"Within the past month, we have submitted NDAs for ZEGERID Capsules and Chewable Tablets, moving us closer to expanding our immediate-release ZEGERID product family. We believe these formulations may provide attractive and convenient immediate-release alternatives for patients suffering from GERD and other upper GI diseases and disorders," said Gerald T. Proehl, president and chief executive officer of Santarus. "Filing the NDA for immediate-release ZEGERID Chewable Tablets is also significant as no other PPI is currently sold as a chewable tablet."

Under the Prescription Drug User Fee Act (PDUFA) guidelines, assuming the FDA accepts the NDA submissions for ZEGERID Capsules and Chewable Tablets, the company expects the FDA to take action on the capsule NDA in late February 2006 and on the chewable tablet NDA in late March 2006, approximately ten months after each NDA submission.

The NDA for ZEGERID Chewable Tablets includes data from two pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trials, one for the 40 mg tablet and one for the 20 mg tablet, which were completed in February 2005. The trials were open-label, randomized, crossover trials, each conducted at a single site. Each trial evaluated the PK/PD profiles of ZEGERID Chewable Tablets 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 Chewable Tablets 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 Chewable Tablets and the delayed-release omeprazole capsules had similar ability to suppress gastric acidity over 24 hours. The 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 gastric acidity on trial day 7. The safety profile of ZEGERID Chewable Tablets 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 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 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 Chewable Tablets 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(R) delayed-release omeprazole capsules and related patent holders that ZEGERID Chewable Tablets 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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