Healthcare Industry News: omeprazole
News Release - January 9, 2006
Santarus Receives Notice From TAP Pharmaceutical Products Inc. Of Intent to Terminate Sublicense AgreementSAN DIEGO--(HSMN NewsFeed)--Jan. 9, 2006--Santarus, Inc. (Nasdaq:SNTS ), 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 rights to develop, manufacture and sell products resulting from the use of the company's immediate-release proton pump inhibitor (PPI) 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® Capsules, an immediate-release formulation of the PPI omeprazole. 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 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 to provide Santarus with certain clinical, regulatory and marketing data associated with TAP's development efforts to date under the sublicense agreement.
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) for ZEGERID Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA) 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 provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® and ZEGERID® are trademarks of Santarus, Inc.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.