Santhera initiates Pivotal Phase III Study with Catena/Sovrima (Idebenone) in Duchenne Muscular Dystrophy

04-Sep-2009 - Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited announced that Santhera has initiated the pivotal Phase III study with Catena®/Sovrima® (INN: idebenone) for the treatment of Duchenne Muscular Dystrophy. The 12-month DELOS study will enroll up to 240 patients in 25 centers in ...

Santhera Enters Agreement with Columbia University to Investigate Additional Potential of Catena in MELAS

29-Jun-2009 - Santhera Pharmaceuticals announced a collaboration with Columbia University in New York to investigate Catena® in a Phase II study as treatment of MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes). The MELAS syndrome is a rare but devastating multisystem disorder ...

Santhera and NIH Collaborate To Evaluate Catena in Primary Progressive Multiple Sclerosis

25-Jun-2009 - Santhera Pharmaceuticals announced a collaboration with the US National Institutes of Health (NIH) to investigate Catena® as potential treatment of Primary Progressive Multiple Sclerosis (PPMS). An estimated 150,000 to 300,000 patients worldwide suffer from this rare but devastating form of ...

Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia

12-Aug-2008 - Santhera Pharmaceuticals gave an update on the clinical and regulatory processes surrounding the commercialization of SNT-MC17/idebenone for the treatment of Friedreich's Ataxia. The Company requested reexamination of the negative opinion by the CHMP regarding Sovrima® (idebenone), despite the ...

Santhera Starts Phase IIb Clinical Trial with JP-1730 in Dyskinesia in Parkinson's Disease

12-Nov-2007 - Santhera Pharmaceuticals and Juvantia Pharma Ltd announced that the first patient has been enrolled into a Phase IIb clinical trial to evaluate JP-1730 (INN: fipamezole) for the treatment of Dyskinesia in Parkinson's Disease (DPD). The study is designed to confirm the dual efficacy of the ...

Santhera Reports Encouraging, First Data from Phase IIa Clinical Trial with SNT-MC17 in Duchenne Muscular Dystrophy

01-Nov-2007 - Santhera Pharmaceuticals announced positive, first results from a 12 month Phase IIa clinical trial with SNT-MC17 (INN: idebenone) in Duchenne Muscular Dystrophy (DMD) as measured by cardiac and respiratory parameters. Santhera therefore is committed to further clinical development of SNT-MC17 in ...

Swissmedic accepts Santhera's filing of SNT-MC17 in Friedreich's Ataxia

05-Oct-2007 - Santhera Pharmaceuticals and Takeda Pharma AG announced that Swissmedic has accepted the filing of an application for authorization for Santhera's lead compound SNT-MC17 for the treatment of Friedreich's Ataxia (FRDA). SNT-MC17 has shown clinical efficacy in FRDA patients on neurological and ...

Santhera: Start of US phase III clinical trial with SNT-MC17

Fast-track designation granted by FDA.

01-Oct-2007 - Santhera Pharmaceuticals announced that it has reached an agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure relating to the Phase III clinical trial to evaluate SNT-MC17 (INN: idebenone) for the treatment of Friedreich's Ataxia (FRDA). ...

Santhera to Seek Canadian Market Approval for SNT-MC17 in Friedreich's Ataxia

24-Sep-2007 - Santhera Pharmaceuticals announces that, with the recent positive decision from Health Canada on eligibility, the Company will file a New Drug Submission (NDS) for SNT-MC17 (INN: idebenone) for the treatment of Friedreich's Ataxia (FRDA). The compound has shown clinical efficacy in FRDA patients ...

European EMEA acceptance of Marketing Authorization Application filing for SNT-MC17 in Friedreich's Ataxia by Santhera

20-Aug-2007 - Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced that the European Medicines Agency (EMEA) has accepted the filing of the Marketing Authorization Application (MAA) for Santhera's lead compound SNT-MC17 (INN: idebenone, originally developed ...