Santarus Announces Effective Date of OTC License Agreement with Schering-Plough.SAN DIEGO -- Santarus, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SNTS SNTS Society for New Testament Studies SNTS Standalone NMD Training System ), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that its license agreement with Schering-Plough HealthCare Products, Inc. for the development, manufacturing and commercialization of ZEGERID([R]) brand products for the over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) market is now effective, following the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. . Santarus expects to receive the $15 million upfront license fee payable under the OTC license agreement on or about November 22, 2006. Under the terms of the OTC agreement, 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. 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 proton pump inhibitor n. A class of drugs that inhibit gastric acid secretion by interfering with the movement of hydrogen ions across cell membranes and are used mainly to treat peptic ulcers, gastroesophageal reflux disease, and esophagitis. (PPI (1) (Pixels Per Inch) The measurement of the resolution of a monitor or scanner. For example, a monitor that is 16 inches wide and displays 1600 pixels across its width would have a resolution of 100 ppi (1600 divided by 16). ) products. In addition to the $15 million upfront license fee, Santarus 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 Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of any ZEGERID OTC products sold by Schering-Plough under the license agreement. Santarus will be obligated ob·li·gate tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates 1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force. 2. To cause to be grateful or indebted; oblige. to pay to the University of Missouri a royalty based on any ZEGERID OTC net sales pursuant to a license agreement between Santarus and the University of Missouri. 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 currently markets ZEGERID Capsules (launched in late March 2006) and ZEGERID 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: risks related to the licensing arrangement with Schering-Plough, 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 Side effects Effects of a proposed project on other parts of the firm. 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 as needed prn. See prn order. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 21E of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Santarus([R]) and ZEGERID([R]) are registered trademarks of Santarus, Inc. |
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