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NDA Filed for First Immediate-Release Proton Pump Inhibitor in a Capsule Formulation
Apr 29, 2005, 09:43, Reviewed by: Dr.
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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.
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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) 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(R) 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. 
- U.S. Food and Drug Administration (FDA)
www.santarus.com
May 12, 2005 Conference Call
As a reminder, the company plans to hold a conference call on May 12, 2005 to discuss first quarter 2005 financial results. Individuals interested in participating in the conference call may do so by dialing (888) 803-8275 for domestic callers, or (706) 643-7736 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of the company's Web site at www.santarus.com.
A webcast replay will be available on the Santarus Web site for 14 days. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 5630456.
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 is also developing a chewable tablet formulation 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: whether the FDA accepts the NDA for ZEGERID Capsules for filing or ultimately approves the NDA 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; Santarus' ability to commercialize either ZEGERID Capsules or Chewable Tablets; Santarus' ability to commercialize ZEGERID 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
Company Contact:
Santarus, Inc.
Martha L. Hough, VP Finance & Investor Relations
858-314-5824
Debra P. Crawford, Chief Financial Officer
858-314-5708
or
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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