Santarus Launches ZEGERID Powder for Oral Suspension 40 mg

    Business Editors/Health/Medical Writers

    SAN DIEGO--(BUSINESS WIRE)--Feb. 22, 2005--

First and Only Immediate-Release Oral Proton Pump Inhibitor Approved for Reduction of Risk of Upper GI Bleeding in Critically Ill Patients

    Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal (GI) diseases and disorders, today announced the U.S. commercial launch of ZEGERID(TM) (omeprazole) Powder for Oral Suspension 40 mg for the reduction of risk of upper GI bleeding in critically ill patients and the short-term treatment (four to eight weeks) of active benign gastric ulcers. Santarus has initiated shipments of ZEGERID Powder for Oral Suspension 40 mg to pharmaceutical wholesalers that distribute to retail pharmacies, hospitals and other institutional customers.
    This product is now being promoted by the Santarus and the Otsuka America Pharmaceutical, Inc. sales forces that together number approximately 400 sales representatives and call on the highest prescribers of proton pump inhibitors (PPIs). Collectively, these physicians were responsible for writing PPI prescriptions that represent nearly one-half of the total prescription PPI market, estimated at $12.5 billion in 2004, according to IMS Health, an independent pharmaceutical market research firm.
    ZEGERID Powder for Oral Suspension 40 mg is a unique immediate-release formulation of omeprazole that rapidly reaches peak plasma levels (in approximately 30 minutes) and provides strong acid control, with a median 24-hour intragastric pH of greater than 4 for 18.6 hours after repeated once-daily dosing. The product was approved by the U.S. Food and Drug Administration (FDA) in late December 2004 and is the only PPI approved to reduce the risk of upper GI bleeding in critically ill patients. Santarus previously launched ZEGERID Powder for Oral Suspension 20 mg in October 2004.
    "Our newly launched ZEGERID 40 mg strength provides immediate release, rapid absorption, strong and sustained acid control and once-daily dosing. Also, study results indicate that ZEGERID provides excellent control of nighttime gastric acidity, with once-daily dosing at bedtime," said Gerald T. Proehl, president and chief executive officer of Santarus. "ZEGERID 40 mg represents an important enhancement to our product portfolio, as the vast majority of PPI prescriptions are written for the highest dose strength available, typically 30 mg or 40 mg. Moreover, as the only PPI approved for use in critically ill patients, ZEGERID 40 mg opens an additional market opportunity for Santarus and offers an important new product for use in this critically ill patient population."
    Commenting about launch activities, William C. Denby, senior vice president, commercial operations, said, "This week we are completing our ZEGERID 40 mg National Launch Meeting, the first sales meeting including both Santarus' and our co-promotion partner Otsuka America's experienced sales teams. In less than two months following regulatory approval, we have ramped up manufacturing, developed and implemented enhanced sales and marketing programs, provided training to the 400 combined Santarus and Otsuka America representatives and launched this product on schedule. Our advertising and promotional campaign supporting the ZEGERID 40 mg product launch will involve journal advertising, speaker programs, web-based initiatives and product sampling."

    About ZEGERID and PPIs

    ZEGERID is the first and only immediate-release oral PPI approved for the U.S. market. Its proprietary immediate-release formulation utilizes an antacid to protect the omeprazole from acid degradation in the stomach, allowing the omeprazole to be quickly absorbed into the blood stream. All other marketed oral PPIs are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, delaying absorption and initial acid suppression.
    ZEGERID 40 mg was approved in December of 2004 for the reduction of risk of upper GI bleeding in critically ill patients and the short-term treatment (four to eight weeks) of active benign gastric ulcers. ZEGERID 20 mg was approved in June of 2004 for short-term treatment of active duodenal ulcer, for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment (four to eight weeks) of erosive esophagitis which has been diagnosed by endoscopy, and for maintenance of healing of erosive esophagitis.
    PPIs are the most frequently prescribed drugs for the treatment of many upper GI diseases and disorders and enjoy widespread use due to their potent acid suppression, favorable safety profile and once-daily dosing.

    Upper GI Bleeding in Critically Ill Patients -- Reducing the Risk

    ZEGERID Powder for Oral Suspension 40 mg is the only PPI approved for the reduction of risk of upper GI bleeding in critically ill patients. Critically ill ventilated patients are at high risk for developing erosions and upper GI bleeding that occur when the gastric mucosa, already compromised by stress, is continuously exposed to significant amounts of acid. It is estimated that as many as 4.0 million critically ill patients are treated annually in the U.S., with 1.5 million at highest risk for upper GI bleeding due to the use of mechanical ventilators.
    Many hospitals treat these patients prophylactically to reduce acid and the risk of upper GI bleeding. Patients who develop upper GI bleeding may require blood transfusions or in some cases may require surgery, which carries a high mortality rate. Results from the study evaluating ZEGERID Powder for Oral Suspension 40 mg in critically ill patients demonstrated that ZEGERID achieved a median gastric pH of greater than 4 within 1 to 2.5 hours after the first dose in 99% of the patients treated and sustained a median daily gastric pH of greater than 4 throughout the 14-day trial in 95% of the patients treated. In the study, 96% of the patients treated with ZEGERID remained free of clinically significant upper GI bleeding.

    Important Safety Information

    ZEGERID Powder for Oral Suspension 40 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients and the short-term treatment (four to eight weeks) of active benign gastric ulcers. ZEGERID Powder for Oral Suspension 20 mg is indicated for short-term treatment of active duodenal ulcer, for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment (four to eight weeks) of erosive esophagitis which has been diagnosed by endoscopy, and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months). ZEGERID is contraindicated in patients with known hypersensitivity to any components of the formulation.
    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. 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.
    ZEGERID contains 460 mg sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq), which should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia.

    About Santarus

    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 received FDA approval to market ZEGERID Powder for Oral Suspension 40 mg in December 2004. The company also is developing capsule and chewable tablet formulations of ZEGERID. 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: Santarus' ability to successfully launch ZEGERID Powder for Oral Suspension 40 mg and to establish market acceptance and demand for ZEGERID Powder for Oral Suspension 20 mg and 40 mg; unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID Powder for Oral Suspension or Santarus' other products under development that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for any of Santarus' products under development; Santarus' ability to obtain additional financing as needed to support its operations; 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 the Private Securities Litigation Reform Act of 1995.

    Santarus(R) and ZEGERID(TM) are trademarks of Santarus, Inc.

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CONTACT: Company Contact: Santarus, Inc. Martha L. Hough, 858-314-5824 Debra P. Crawford, 858-314-5708 or Investor Contact: Lippert/Heilshorn & Associates, Inc. Jody Cain or Bruce Voss, 310-691-7100 jcain@lhai.com bvoss@lhai.com or Media Contact: Biosector 2 Sheryl Seapy, 949-608-0841

KEYWORD: CALIFORNIA INDUSTRY KEYWORD: ADVERTISING/MARKETING PHARMACEUTICAL MEDICAL PRODUCT SOURCE: Santarus, Inc.

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