12.10.2009 08:00:00
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Santarus and Norgine Enter License for ZEGERID Immediate-Release Omeprazole Products in Europe
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, and Norgine B.V., a European specialty pharmaceutical company, today announced that they have entered into a licensing agreement granting exclusive rights to Norgine to develop, manufacture and commercialize prescription immediate-release ZEGERID® products incorporating the proton pump inhibitor omeprazole in combination with one or more buffering agents in specified markets in Western, Central and Eastern Europe.
Under the license agreement, Norgine will pay Santarus a $2.5 million upfront fee. Santarus will also be entitled to receive up to an additional $10 million in milestone payments upon the achievement of certain regulatory events, subject to reductions based on Norgine’s actual out-of pocket costs directly related to its clinical, regulatory and reimbursement efforts for a "major” country as defined under the license agreement. Norgine will also pay Santarus tiered royalties ranging from the mid- to high-teens, subject to reduction in certain limited circumstances, on net sales of any products sold under the license agreement.
"As a leading European specialty pharmaceutical company and with a focus on gastroenterology products, Norgine is an ideal partner for Santarus,” said Gerald T. Proehl, president and chief executive officer of Santarus. "This license for markets in Europe is further execution of our strategy to maximize the value of our immediate-release ZEGERID proton pump inhibitor technology.”
Peter Stein, chief executive officer of Norgine, said, "This license agreement with Santarus supports our objective to use our European infrastructure to bring innovative products to our markets. We look forward to developing ZEGERID immediate-release omeprazole products in the markets covered under our agreement.”
About Norgine
Norgine is an independent, successful European specialty pharmaceutical company that has been established for over 100 years and has a presence in all the major European markets. In 2008, Norgine celebrated its 22nd consecutive year of double-digit growth at constant exchange rates. The company employs over 1,000 people.
Norgine’s current focus is pharmaceutical products that address significant unmet clinical need in areas such as gastroenterology, hepatology and pain management. The company currently markets a range of products in its key therapeutic areas, e.g. MOVICOL® for the treatment of chronic constipation and fecal impaction, MOVIPREP® a new generation bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, XIFAXAN® for the treatment of travelers’ diarrhea, FIVASA® for the treatment of ulcerative colitis and Crohn’s disease and ORAMORPH® for the treatment of moderate to severe pain associated with cancer.
Norgine has an active research and development effort and currently has products at various stages of clinical development. Norgine manufactures most of its own products in Hengoed, Wales and Dreux in France.
Norgine’s website is www.norgine.com.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. 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. These forward-looking statements include statements regarding the potential commercialization of Santarus’ immediate-release omeprazole products in Western, Central and Eastern Europe and the potential for Santarus to receive milestone and royalty payments from Norgine. 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 license agreement with Norgine, including the success of Norgine’s development and commercialization activities, Norgine’s ability to obtain regulatory approvals in the licensed international markets, Norgine’s level of commitment and the potential for termination of the agreement; the scope and validity of patent protection for the licensed products and Norgine’s ability to commercialize licensed products without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of the licensed 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 in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals 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 registered trademarks of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX® is a registered trademark of Cosmo Technologies Limited.
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