Santhera Presents Positive Data from IONIA Open-Label Extension Study in Friedreich's Ataxia

06-May-2011 - Santhera Pharmaceuticals announced that it will present positive data from an open-label extension study (IONIA-E) evaluating Catena® for the treatment of Friedreich's Ataxia. The findings indicate that Catena® can offer therapeutic benefit to pediatric patients by improving overall neurological ...

Santhera's MICONOS Trial with Catena/Sovrima in Friedreich's Ataxia Misses Primary Endpoint

21-May-2010 - Santhera Pharmaceuticals announced that its MICONOS Phase III study evaluating Catena®/Sovrima® for the treatment of Friedreich's Ataxia missed its primary endpoint. Trends towards improvement in the key neurological endpoint were however identified by a meta-analysis of all Santhera's Phase II ...

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 ...

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 ...

Santhera and Takeda Extend European Marketing Collaboration for SNT-MC17 into Duchenne Muscular Dystrophy

06-Aug-2007 - Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited announced they have extended their existing commercialization partnership for SNT-MC17 (INN: idebenone) in the European Union and Switzerland to cover the compound's second indication of Duchenne Muscular Dystrophy (DMD). SNT-MC17 ...

Santhera Licenses Omigapil for Treatment of Rare Neuromuscular Diseases

03-Jul-2007 - Santhera Pharmaceuticals announced a licensing agreement with Novartis covering the compound omigapil for the treatment of Congenital Muscular Dystrophy (CMD). Under this agreement Santhera will develop omigapil as a potential treatment for this severe, genetically determined neuromuscular ...

Santhera Starts European Phase III Study with its Lead Compound SNT-MC17 (idebenone) in Friedreich's Ataxia

16-Dec-2005 - Santhera Pharmaceuticals AG announced that it has started a European Phase III clinical study with its lead product SNT-MC17 (idebenone) in Friedreich's Ataxia (FRDA). The design of this study reflects the company's discussions with EMEA which took place earlier this year and will evaluate both ...