NDA Filed for Omeprazole Chewable Tablets
May 27, 2005, 17:46, Reviewed by: Dr.
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We believe these formulations may provide attractive and convenient immediate-release alternatives for patients suffering from GERD and other upper GI diseases and disorders."
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By Santarus, Inc.,
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. 
- U.S. Food and Drug Administration (FDA)
www.santarus.com
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 an NDA for ZEGERID Capsules to the FDA in April 2005 and submitted an NDA for ZEGERID Chewable Tablets to the FDA in May 2005. 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: whether the FDA accepts the NDAs for ZEGERID Capsules and Chewable Tablets for filing or ultimately approves the NDAs under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for one or more of the desired indications in a timely manner or at all; whether, subject to receipt of FDA approval, Santarus is able to generate market demand and acceptance for ZEGERID Capsules or Chewable Tablets; Santarus' ability to commercialize ZEGERID Powder for Oral Suspension, Capsules or Chewable Tablets without infringing the patent rights of others; 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(R) and ZEGERID(R) are trademarks of Santarus, Inc.
Contacts
Santarus, Inc.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
or
Debra P. Crawford, 858-314-5708
Chief Financial Officer
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Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Jody Cain ([email protected])
Bruce Voss ([email protected])
310-691-7100
or
Media Contact:
Biosector 2
Sheryl Seapy, 949-608-0841
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