Santarus Announces Launch Of ZEGERID Products By GlaxoSmithKline In Puerto Rico And U.S. Virgin Islands

Main Category: GastroIntestinal / Gastroenterology
Article Date: 19 Feb 2008 - 8:00 PDT

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Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, announced that GlaxoSmithKline plc (GSK) has launched ZEGERID (omeprazole/sodium bicarbonate) Capsules and ZEGERID (omeprazole/sodium bicarbonate) Powder for Oral Suspension in Puerto Rico and the U.S. Virgin Islands. The ZEGERID products were developed by Santarus and are the first and only immediate-release oral proton pump inhibitors (PPIs) commercialized in the U.S. According to the market research firm IMS Health Incorporated, retail sales of prescription PPI products in Puerto Rico and the U.S. Virgin Islands were approximately $124 million for the 12 months ended September 30, 2007 and grew at 24% compared with the prior 12 month period.

"We are very pleased that GSK, a highly regarded global pharmaceutical company with well-established commercialization capabilities, is making our ZEGERID products available to patients in Puerto Rico and the U.S. Virgin Islands," said Gerald T. Proehl, president and chief executive officer of Santarus, Inc. "GSK has long demonstrated success in marketing products in the gastrointestinal therapeutic area, and we believe it is the ideal partner to bring physicians in these regions the message about the benefits of ZEGERID products."

Santarus and GSK entered into a distribution agreement in November 2007 under which GSK will distribute, market and sell ZEGERID brand prescription products in Puerto Rico and the U.S. Virgin Islands. At the same time, Santarus licensed rights to GSK to develop, manufacture and commercialize immediate-release omeprazole products in up to 114 countries in GSK's International Region, including in Africa, Asia, the Middle-East, and Central and South America. According to IMS Health, retail sales of PPI products in the covered territories were estimated to be approximately $2 billion for the 12 months ended September 30, 2007 and grew at approximately 22% compared with the prior 12 month period. The license agreement excludes the U.S., Europe, Australia, Japan and Canada.

About ZEGERID Prescription Products

ZEGERID (omeprazole/sodium bicarbonate) Capsules and ZEGERID (omeprazole/sodium bicarbonate) 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 proton pump inhibitor (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 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 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.

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 http://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: risks related to the success of GSK's distribution, sales and marketing activities in Puerto Rico and the U.S. Virgin Islands as well as its commercialization activities in the licensed international territories; GSK's level of commitment to the distribution, sales and marketing of ZEGERID in Puerto Rico and the U.S. Virgin Islands and to its commercialization activities in the licensed international territories; adverse side effects or inadequate therapeutic efficacy of ZEGERID that could delay or prevent product commercialization, or that could result in recalls or product liability claims; 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.

http://www.santarus.com