Healthcare Industry News: proton
News Release - May 28, 2008
Santarus Announces Development Program for New ZEGERID Prescription ProductSAN DIEGO--(HSMN NewsFeed)--Santarus, Inc. (NASDAQ:SNTS ), a specialty pharmaceutical company, today announced that it is developing a new tablet formulation to add to its ZEGERID® family of branded prescription pharmaceutical products. The new formulation is a swallowable tablet that combines immediate-release omeprazole, a proton pump inhibitor (PPI), with a mix of buffers. Santarus plans to undertake clinical and stability studies with the tablet in preparation for the submission of a New Drug Application to the U.S. Food and Drug Administration. The company’s objective is to have the new ZEGERID tablet product commercially available in the U.S. in the second half of 2009.
“Our goal was to design an optimized tablet formulation that has the potential to provide features and benefits that are important to physicians and their patients. We have evaluated the new formulation in a pilot clinical study with positive results,” said Gerald T. Proehl, president and chief executive officer of Santarus. “Our progress in developing a ZEGERID tablet formulation reflects our past experience in developing other immediate-release PPI products. We have a successful track record of moving quickly through product and clinical development to regulatory approval for ZEGERID Capsules and Powder for Oral Suspension. We are focused on achieving similar results for this new ZEGERID formulation so we can expand the ZEGERID family of product offerings.”
About Currently Marketed ZEGERID Prescription Products
ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers. ZEGERID Powder for Oral Suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.
ZEGERID Capsules and Powder for Oral Suspension 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 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 and Powder for Oral Suspension 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 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information. 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. ZEGERID Powder for Oral Suspension contains 460 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 contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.
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: difficulties or delays associated with Santarus’ product development activities, including product stability, and clinical testing for the new tablet formulation; whether the new tablet formulation achieves the intended safety and efficacy profile and demonstrates features and benefits that are important to physicians and their patients; the timing for commercial availability of the new tablet product and potential for delays associated with the clinical testing and regulatory approval processes; adverse side effects or inadequate therapeutic efficacy of Santarus’ products that could result in product recalls, market withdrawals or product liability claims; competition from other pharmaceutical or biotechnology companies and evolving market dynamics, including the impact of currently available generic PPI products and the introduction of additional generic PPI products; the scope and validity of patent protection for the new tablet formulation and Santarus’ other ZEGERID products, including the outcome and duration of the pending patent infringement lawsuits against Par Pharmaceutical, Inc., and Santarus’ ability to commercialize the new tablet formulation and its other ZEGERID products without infringing the patent rights of others; 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® and ZEGERID® are registered trademarks of Santarus, Inc.
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