Santarus Inc. To License Heartburn Drug Rights To Schering-Plough Corporation; Santarus May Receive Up To $65 Million
Schering-Plough will be responsible for the development, manufacturing and commercialization of OTC ZEGERID products with the lower dosage strength of 20 mg of omeprazole for heartburn-related indications. According to A.C. Nielsen, a market research firm, the OTC market for heartburn products was approximately $1.1 billion for the 12 months ending mid-August 2006. Santarus will continue to manufacture, promote and sell ZEGERID products in both 40 mg and 20 mg dosage strengths of omeprazole for their approved prescription indications in the U.S. prescription market for proton pump inhibitor (PPI) products. The U.S. prescription PPI market was approximately $13.4 billion for the 12 months ending July 2006 according to IMS Health, a market research firm.
Under the terms of the agreement, Santarus will receive a $15 million upfront license fee payable following the effective date of the agreement and may receive up to an additional $65 million in milestone payments upon the achievement of certain regulatory and sales milestones. Santarus will also receive a royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold by Schering-Plough under the license agreement. A portion of these royalties will be paid to the University of Missouri pursuant to a license agreement between Santarus and the University of Missouri. The terms of the OTC agreement with Schering-Plough are subject to review under the Hart-Scott-Rodino Antitrust Improvements Act (HSR), and the parties will seek early termination of the HSR waiting period.
"We are very pleased to enter into this agreement with Schering-Plough, with its longstanding leadership position of successfully commercializing major OTC brands," said Gerald T. Proehl, president and chief executive officer of Santarus. "We believe the development of ZEGERID products appropriate for the OTC market will provide a healthcare benefit to consumers and may have a positive future impact on overall awareness of our prescription ZEGERID products, the significant majority of which are currently prescribed at the higher 40 mg dosage strength."
Conference Call
Santarus has scheduled an investor conference call regarding this announcement at 10:00 a.m. Eastern Time (7:00 a.m. Pacific Time) today, October 18, 2006. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 9062736. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company's Web site at www.santarus.com, and a recording of the call will be available on the company's Web site for 14 days following the completion of the call.
About Currently Marketed ZEGERID Prescription Products
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 gastrointestinal 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 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 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
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.
About Santarus
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 U.S. Food and Drug (FDA) approval for its third dosage form, ZEGERID with 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: risks related to the licensing arrangement with Schering-Plough, including the termination of the waiting period under the HSR Act, the success of Schering-Plough's development, sales and marketing activities, and Schering-Plough's level of commitment and the potential for termination of the arrangement; Santarus' ability to drive increased market demand for, and generate increased sales of, ZEGERID Capsules, ZEGERID Powder for Oral Suspension and any other products that may be marketed; the scope and validity of patent protection for ZEGERID products and Santarus' and Schering-Plough's ability to commercialize ZEGERID products without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID 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 ZEGERID products; 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 Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc.
Contact: Company Contact: Santarus, Inc. Martha L. Hough, VP Finance & Investor Relations 858-314-5824 or Debra P. Crawford, Chief Financial Officer 858-314-5708 or Investor Contact: Lippert/Heilshorn & Associates, Inc. Jody Cain, jcain@lhai.com Eleanor Tang, etang@lhai.com 310-691-7100
Source: Santarus, Inc.