Santarus Receives Notice From TAP Pharmaceutical Products Inc. Of Intent to Terminate Sublicense Agreement.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Santarus, Inc. (Nasdaq: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 it has received notice from TAP Pharmaceutical Products Inc. (TAP), pursuant to the terms of the sublicense agreement entered into in June 2002, that TAP is exercising its right to terminate the sublicense agreement without cause, effective March 7, 2006, 60 days from the date of notice. Under the terms of the sublicense agreement, Santarus granted TAP the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. rights to develop, manufacture and sell products resulting from the use of the company's immediate-release 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). ) technology with lansoprazole, a PPI. "Since the signing of the sublicense agreement in 2002, Santarus has made significant progress in the advancement of its immediate-release PPI technology. Today we are focused on preparing for the commercial launch, subject to receipt of regulatory approval, of ZEGERID(R) Capsules, an immediate-release formulation of the PPI omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with . We believe that offering a capsule with the same immediate-release technology that is currently available in ZEGERID Powder for Oral Suspension will provide a convenient dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. to further address the unmet needs of patients suffering from upper GI diseases and disorders. With the return of these technology rights, we now regain exclusive worldwide rights to the immediate-release PPI technology utilized in our ZEGERID family of products," said Gerald T. Proehl, president and chief executive officer of Santarus. Prior to the termination of the sublicense agreement, Santarus received an $8.0 million upfront payment from TAP in July 2002 following the execution of the sublicense agreement and a $10.0 million milestone payment in February 2005 related to TAP achieving its first development milestone. Following the termination of the sublicense agreement, Santarus will retain exclusive worldwide rights to its immediate-release PPI technology, and TAP 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 provide Santarus with certain clinical, regulatory and marketing data associated with TAP's development efforts to date under the sublicense agreement. 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 launched ZEGERID Powder for Oral Suspension 40 mg in February 2005. The company submitted a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ZEGERID Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in April 2005 and submitted an NDA for ZEGERID Chewable Tablets 40 mg and 20 mg to the FDA in May 2005. 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: whether the FDA ultimately approves the pending NDA for ZEGERID Capsules for one or more of the desired indications in a timely manner or at all; the company's ability to establish market acceptance and demand for the ZEGERID family of products; Santarus' ability to continue to commercially utilize and protect the exclusive worldwide rights to its immediate-release PPI technology; 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 trademarks of Santarus, Inc. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion