Healthcare Industry News: GERD
News Release - March 28, 2006
Santarus Announces U.S. Launch of ZEGERID CapsulesFirst and Only Immediate-Release Oral Proton Pump Inhibitor in Convenient Capsule Form
SAN DIEGO--(HSMN NewsFeed)--March 28, 2006--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® (omeprazole/sodium bicarbonate) Capsules 40 mg/1100 mg and 20 mg/1100 mg, an immediate-release proton pump inhibitor (PPI). ZEGERID Capsules were approved by the U.S. Food and Drug Administration (FDA) on February 27, 2006.
Capsules and swallowable tablets are the most frequently prescribed dosage forms for patients taking PPIs, constituting more than 98 percent of the PPI prescription market. The PPI market, including five delayed-release PPI brands, had U.S. prescription sales of $12.8 billion in 2005, according to IMS Health, an independent pharmaceutical market research firm.
Santarus is launching ZEGERID Capsules with a combined sales force with its co-promotion partner Otsuka America Pharmaceutical, Inc. of approximately 370 sales representatives who are targeting 26,000 of the highest PPI-prescribing physicians in the U.S. Independent research has indicated that these targeted physicians wrote prescriptions that accounted for approximately $4.4 billion in PPI sales during 2005.
"We plan to continue building on the ZEGERID brand recognition we have established in the marketplace, and with the introduction of ZEGERID Capsules, seek to strengthen our competitive position as the first and only immediate-release oral proton pump inhibitor," said Gerald T. Proehl, president and chief executive officer of Santarus. "Studies have shown that ZEGERID offers patients a unique pharmacological profile -- rapidly reaching maximal blood levels within 30 minutes, achieving 24-hour acid control and providing effective nighttime and daytime acid control."
Santarus has achieved its planned initial distribution of ZEGERID Capsules to pharmaceutical wholesalers, retail pharmacies, hospitals and other institutional customers. Samples of ZEGERID Capsules have also been shipped to Santarus and Otsuka sales representatives for distribution to their target physicians.
In addition to the product sampling program, other planned promotional activities include the introduction of a new advertising campaign and corresponding print advertisements in leading medical journals, as well as a new program aimed at increasing ZEGERID trial time by providing patients with immediate savings on initial prescriptions.
ZEGERID Capsules are priced with a wholesale acquisition cost, or WAC, of $3.24 per 40 mg or 20 mg dose. At this price, Santarus believes ZEGERID Capsules will offer an attractive value to physicians and their patients as the lowest priced branded PPI capsule or swallowable tablet, representing an approximately 23 percent savings compared to the market-leading PPI.
ZEGERID Capsules and ZEGERID Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), the short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy and active benign gastric ulcers, the short-term treatment of active duodenal ulcers and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months). ZEGERID Powder for Oral Suspension is also indicated for the reduction of risk of upper GI bleeding in critically-ill patients.
ZEGERID offers a distinct pharmacological profile -- rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control, with a median 24-hour gastric pH of greater than 4 ranging 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 anytime during the 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, 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 sodium bicarbonate in lieu of an enteric coating. The sodium bicarbonate 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
ZEGERID (omeprazole/sodium bicarbonate) 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.
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 300 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 mEq), and ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq). 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.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients. The company's products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company's marketed products include ZEGERID Capsules (launched in late March 2006) and ZEGERID Powder for Oral Suspension. Santarus received FDA approval for its third dosage form, ZEGERID with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets, in March 2006. 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 and drive market demand for Zegerid Capsules, as well as continue to generate commercial sales of Zegerid Powder for Oral Suspension and any other products that may be marketed; Santarus' ability to obtain additional financing as needed to support its operations; the scope and validity of patent protection for Santarus' products and Santarus' ability to commercialize its products without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus' products 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; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval 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 trademarks of Santarus, Inc.
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