ZegeridTreatment for Duodenal Ulcer, Gastroesophageal Reflux Disease, Gastric Ulcer, Erosive Esophagitis
Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target
SAN DIEGO, April 28, 2005 - 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 (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 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.
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.
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.
For more information, please visit www.santarus.com.
Posted: April 2005
- Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA - February 24, 2006
- Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets - July 26, 2005
- Santarus Announces FDA Acceptance of New Drug Application For Zegerid Capsules; FDA Action Expected in Early 2006 on NDA for First Immediate-Release Proton Pump Inhibitor in Capsule Formulation - June 28, 2005
- Santarus Submits New Drug Application for Zegerid Chewable Tablets - May 27, 2005
- Zegerid Santarus, Inc. - Treatment for Heartburn/GERD, Erosive Esophagitis, Duodenal Ulcers - June 15, 2004
- FDA Accepts for Filing Santarus' New Drug Application for Rapinex Powder for Oral Suspension 40mg - April 29, 2004