Santarus Announces Positive Clinical Results with Zegerid Capsules in Controlling Gastric Acidity Over 24 Hours
PPIs are used to treat GERD because they reduce the production of gastric acid. A typical measure of gastric acid control is the ability of a therapy to maintain gastric pH at a level greater than 4. The primary endpoint of the open-label, randomized, crossover study was to evaluate the effects of morning dosing of ZEGERID Capsules, Protonix tablets and Prevacid capsules on 24-hour gastric acid control by measuring the percent time gastric pH was greater than 4.
The study data indicated that the percent time gastric pH was greater than 4 for patients taking ZEGERID was approximately 43% longer than patients treated with Protonix (p less than 0.001) and approximately 22% longer than patients treated with Prevacid (p=0.005). Data were evaluated after seven continuous days of once-daily dosing before breakfast. Colin Howden, M.D., Division of Gastroenterology, Northwestern University Feinberg School of Medicine, helped to design the study and consulted on it.
"We believe these positive clinical results, together with the favorable results of our previously conducted studies, support the benefits of treating GERD patients with ZEGERID for both daytime and nighttime acid control," said Gerald T. Proehl, president and chief executive officer of Santarus, Inc. "In addition to the advantage of immediate-release ZEGERID's rapid absorption, we saw a difference in the duration of acid control with chronic morning dosing as measured on day seven of the trial."
ZEGERID Capsules (omeprazole/sodium bicarbonate) contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation. ZEGERID Capsules are indicated for the treatment of heartburn and other symptoms associated with GERD, erosive esophagitis, and gastric and duodenal ulcers.
ZEGERID products offer a distinct pharmacological profile - rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control. While the correlation of pharmacodynamic data to clinical effect has not been established, the median percentage of time gastric pH was greater than 4 over 24 hours in patients treated with ZEGERID in a pharmacodynamic study ranged from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. ZEGERID can be conveniently taken once-a-day on an empty stomach, at least one hour before a meal.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs in the U.S., other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID Capsules utilize an antacid in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.
Important Safety Information
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator (acid-controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID Capsules contain 303 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg ZEGERID Capsules contain the same amount of sodium bicarbonate (1100 mg per capsule), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company's current marketing efforts are primarily focused on ZEGERID Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. 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: unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; other difficulties or delays in development, testing, manufacturing and marketing of, and maintaining regulatory approvals 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 registered trademarks of Santarus, Inc. All other trademarks appearing in this press release are the property of their respective owners.
Martha L. Hough, VP Finance & Investor Relations
Debra P. Crawford, Chief Financial Officer
Lippert/Heilshorn & Associates, Inc.
Jody Cain or Eleanor Tang, 310-691-7100
Posted: January 2008