Santarus and Depomed Announce Settlement with Lupin of GLUMETZA Patent Litigation
SAN DIEGO & MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 22, 2012 - Santarus, Inc. (NASDAQ:SNTS) and Depomed, Inc. (NASDAQ:DEPO) today announced that they have entered into a settlement agreement with Lupin Ltd. and its subsidiary, Lupin Pharmaceuticals, Inc., to resolve pending patent litigation involving GLUMETZA® (extended release metformin tablets) 1000 mg and 500 mg.
The settlement agreement grants Lupin the right to begin selling a generic version of GLUMETZA on February 1, 2016, or earlier under certain circumstances. The settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, as well as entry by the U.S. District Court for the Northern District of California of an order dismissing the litigation.
Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. GRALISE™ (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol.
Santarus also has a diverse pipeline, including three investigational drugs in late-stage clinical development: UCERIS™ (budesonide) tablets for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers' diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available at www.santarus.com.
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 either Santarus or Depomed that any of their respective 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 or Depomed's businesses, including, without limitation: risks related to the settlement agreement with Lupin, including any legal or regulatory challenge to the settlement agreement by the U.S. Department of Justice and/or the Federal Trade Commission, and the outcome of any such challenge; risks related to the commercialization arrangement between Santarus and Depomed (including Santarus' ability to increase market demand and sales of GLUMETZA products; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of GLUMETZA products; the ability to ensure continued supply of GLUMETZA products in the U.S. market; the scope and validity of patent protection for GLUMETZA products, including the outcome and duration of the ongoing GLUMETZA patent litigation; and the potential for termination of the commercialization agreement); and other risks detailed in Santarus and Depomed's prior press releases and 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 neither Santarus nor Depomed undertakes any 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®, FENOGLIDE® and UCERIS™ are trademarks of Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a trademark of VeroScience LLC. MMX® is a trademark of Cosmo Technologies Limited. RHUCIN® is a trademark of Pharming Group NV. GRALISE™ is a trademark of Depomed, Inc.
Contact: SANTARUS CONTACTS:
Martha L. Hough
VP Finance & Investor Relations
Debra P. Crawford
Chief Financial Officer
Jody Cain (firstname.lastname@example.org)
Bruce Voss (email@example.com)
August J. Moretti
Chief Financial Officer
Posted: February 2012