News: Positive Clinical Data with Santarus' ZEGERID Capsules in …
Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company,
today announced the presentation of an abstract at the Digestive
Disease Week (DDW) annual meeting of positive pharmacodynamic study
results indicating that, after seven days of pre-breakfast dosing,
ZEGERID(R) (omeprazole/sodium bicarbonate) Capsules 40 mg/1100 mg
produced significantly greater and significantly faster control of
gastric acidity in patients with gastroesophageal reflux disease
(GERD) than two comparator drugs. The clinical study evaluated the
effect of morning dosing of immediate-release ZEGERID Capsules,
Protonix(R) (pantoprazole sodium) Delayed-Release Tablets 40 mg and
Prevacid(R) (lansoprazole) Delayed-Release Capsules 30 mg on 24-hour
gastric acid control. The clinical data were presented by Colin W.
Howden, M.D., Division of Gastroenterology, Northwestern University
Feinberg School of Medicine, in a poster session on May 18, 2008.
All three drugs are proton pump inhibitors (PPIs) used to treat
GERD by reducing 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. Clinical data from a total of 51
patients were analyzed in the open-label, randomized, crossover study.
The primary endpoint of the study was to evaluate the effects of
pre-breakfast 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 on the seventh day of
once-daily, pre-breakfast dosing.
The study results indicated that the percent time gastric pH was
greater than 4 with ZEGERID was approximately 43% longer than with
Protonix (p less than 0.001) and approximately 22% longer than with
Prevacid (p=0.005). In addition ZEGERID was associated with more rapid
control of gastric acidity. ZEGERID achieved a pH greater than 4
within 20 minutes, compared with 70 minutes for Protonix and 65
minutes for Prevacid (p less than 0.001 for both comparisons). There
were no clinically meaningful differences in the number or nature of
adverse events reported in this study among the three drugs. Santarus
had previously reported top-line results from this clinical trial in
January 2008.
“We are very pleased to present these favorable clinical results
at the DDW meeting, which is the largest meeting for
gastroenterologists during the year,” said Gerald T. Proehl, president
and chief executive officer of Santarus. “These study results
reinforce our message that ZEGERID is the only oral PPI that offers
immediate-release for rapid and sustained control of gastric acidity
in GERD patients whether dosed in the morning or at night.”
About ZEGERID Prescription Products
ZEGERID (omeprazole/sodium bicarbonate) Capsules 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. 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 304 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.
About Santarus
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.
