Health & Fitness
Health and Fitness
Health and Fitness 
Thu, March 10, 2011
Santarus Initiates Phase I Clinical Study with SAN-300
SAN DIEGO--([ BUSINESS WIRE ])--Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody. The randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation study is being conducted in Australia in a total of approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis. The objectives of the study are to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300. The company expects to complete this Phase I clinical study with SAN-300 in the first half of 2012.
"We believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation"
aWe believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation,a said Santarus president and chief executive officer Gerald T. Proehl.
Santarus senior vice president of clinical research Mark C. Totoritis, M.D., said, aSAN-300 targets a major collagen receptor, VLA-1 (11 integrin), and has shown activity in multiple preclinical models of inflammation. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation.a
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.
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 physician specialists. The companya™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.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® 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 travelersa™ diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available on the companya™s website 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 attributes of SAN-300, its potential to treat various autoimmune and inflammatory diseases and the potential timing for completion of the Phase I clinical study. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives 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 timing and success of the Phase I study; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of SAN-300; the scope and validity of patent protection or other regulatory exclusivity for SAN-300; risks related to the license agreement between Santarus and Biogen Idec, including the potential for termination of the agreement; 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 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® is a trademark 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.