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Santhera Pharmaceutical Holding Ltd

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News releases

The information in the news releases on these pages was factually accurate on the date of publication. These news releases remain on Santhera´s website for historical purposes only. Santhera assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.

2013

June 06, 2013: Santhera Secures Exclusive Rights from NIH for a Novel Approach for the Treatment of Primary Progressive MS

May 13, 2013: Santhera's Shareholders Support Business Continuation and Evaluation of Strategic Options

April 18, 2013: Santhera Publishes Agenda for Annual Shareholders' Meeting

April 16, 2013: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of CatenaŽ in Duchenne Muscular Dystrophy

April 16, 2013: Santhera Reports 2012 Financial Figures and Announces Restructuring

March 22, 2013: Santhera Withdraws Marketing Authorization Application for RaxoneŽ in LHON

February 28, 2013: Santhera Explores Strategic Options; Updates Financial Calendar

February 27, 2013: Santhera to Discontinue Sale of CatenaŽ in Canada

January 18, 2013: Santhera Receives a Negative Opinion on its Marketing Authorization Application for RaxoneŽ. Plans to Request Re-examination

2012

November 16, 2012: Santhera expects CHMP opinion on its MAA for RaxoneŽ early 2013

August 31, 2012: Santhera Reports Stable Product Sales and Substantially Reduced Expenses and in First Half Year of 2012

April 23, 2012: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

April 11, 2012: Santhera Joins EU-funded EndoStem Consortium in Preparation for Clinical Study with Omigapil in Congenital Muscular Dystrophies

February 24, 2012: Santhera Reports Stable Product Sales in 2011 and Cash Reserves of CHF 23.4 Million Following Completion of Restructuring

January 24, 2012: Santhera and Ipsen Renegotiate Fipamezole Licensing Agreement

2011

October 19, 2011: Santhera Presents Clinical Data of CatenaŽ in Duchenne Muscular Dystrophy at the 2011 Congress of the World Muscle Society

September 12, 2011: Santhera to Present at Biotech in Europe Investor Forum

August 29, 2011: Santhera Announces Interim Financial Results for the First Half Year of 2011 and Restructuring Plans to Concentrate on CatenaŽ Franchise

August 24, 2011: Santhera Obtains US Patent for Use of CatenaŽ in the Treatment of Muscular Dystrophies

August 23, 2011: Disclosure of shareholdings in accordance with articles 20 and 21 SESTA

July 27, 2011: Publication in BRAIN Highlights Medical Potential of Santhera's CatenaŽ in Leber's Hereditary Optic Neuropathy

July 22, 2011: Santhera's Marketing Authorization Application for Idebenone in LHON Accepted for Review by European Medicines Agency

June 06, 2011: Santhera Presents Nonclinical Data in LHON at the Joint Congress of SOE/AAO 2011

May 27, 2011: Data from Santhera's RHODOS Study to Be Presented at the European Neurological Society 2011 Meeting

May 19, 2011: Santhera to Present at BioEquity Europe

May 09, 2011: Santhera Presents Data from 2-Year Open-Label Intervention Study with CatenaŽ in Duchenne Muscular Dystrophy at the MYOLOGY 2011 Conference

May 05, 2011: Santhera Presents Positive Data from IONIA Open-Label Extension Study in Friedreich's Ataxia at the Fourth International Friedreich's Ataxia Scientific Conference

April 13, 2011: Santhera Pharmaceuticals to Present at the 2011 American Academy of Neurology Annual Meeting

April 11, 2011: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

April 07, 2011: Santhera Publishes 2010 Annual Report

April 05, 2011: Publication Highlights Mode of Action for Santhera's CatenaŽ and its Relevance for Mitochondrial Disorders

February 25, 2011: Santhera 2010 Results (news kit)

February 25, 2011: Santhera Reports 2010 Revenue of CHF 20.6 million and Prepares for MAA Filing in LHON

February 18, 2011: Fipamezole Transition from Biovail completed - Program Well Advanced Towards Phase III

February 08, 2011: Santhera Obtains US and Canadian Patents for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy

February 02, 2011: Statement

January 25, 2011: Santhera Statement

January 19, 2011: Santhera to Present at the European Life Science CEO Forum

January 05, 2011: Santhera to Present at the Biotech Showcase 2011

2010

December 07, 2010: Santhera Obtains European Patent for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy

October 25, 2010: Santhera Regains Full Rights to Fipamezole in North America

October 14, 2010: Santhera Licenses Melanocortin-4 Receptor Antagonist Program to BioLineRx

September 29, 2010: Santhera Prepares for Pivotal Study with Omigapil in Congenital Muscular Dystrophy

September 22, 2010: Santhera Announces Intent To File Marketing Authorization Application for Leber's Hereditary Optic Neuropathy

September 14, 2010: Santhera Releases Additional Clinical Data Supporting the Use of CatenaŽ in LHON

September 03, 2010: Santhera Reports 2010 Interim Financial Results with Significant Reduction in Net Loss and Strong Increase in Product Sales

September 03, 2010: Santhera and Ipsen Enter into Licensing Agreement for Fipame-zole for the Treatment of Dyskinesia in Parkinson's Disease

August 13, 2010: Santhera Obtains European Patent for Use of CatenaŽ/SovrimaŽ in the Treatment of Muscular Dystrophies

July 15, 2010: Data from Santhera's CatenaŽ in Leber's Hereditary Optic Neuropathy Will Be Presented at the mitoNET Congress for Mitochondrial Medicine 2010

June 16, 2010: Santhera's CatenaŽ Improved Vision in Patients with Leber's Hereditary Optic Neuropathy; Regulatory Submissions Planned in First Half of 2011

May 20, 2010: Santhera's MICONOS Trial with CatenaŽ/SovrimaŽ in Friedreich's Ataxia Misses Primary Endpoint

April 26, 2010: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

February 26, 2010: Santhera 2009 Results (news kit)

February 26, 2010: Santhera Reports Strong 2009 Revenues of CHF 22.3m and Is Financed Beyond 2011

2009

December 07, 2009: Santhera Presents New Data on MC-4R Antagonist Program for Treatment of Cancer Cachexia

November 03, 2009: Santhera Receives Grant from Association Française contre les Myopathies for its Omigapil Program in Congenital Muscular Dystrophy

October 05, 2009: Santhera Reports Closing of Juvantia Acquisition and Final Upfront Payment from Partner Biovail

September 04, 2009: Santhera Reports Solid 2009 Interim Financial Results; Well Funded into H2 2011

September 02, 2009: Initiation of Pivotal Phase III Study with CatenaŽ/SovrimaŽ (Idebenone) in Duchenne Muscular Dystrophy

August 31, 2009: Santhera to Implement Named Patient Program for CatenaŽ in Europe

August 24, 2009: Santhera and Biovail Enter into License Agreement to Develop and Commercialize JP-1730/Fipamezole in North America

August 17, 2009: Santhera Acquires Juvantia and Secures All Rights to JP-1730/Fipamezole

August 03, 2009: Santhera Enrolls Last Patient in RHODOS Study Evaluating CatenaŽ in Leber's Hereditary Optic Neuropathy

July 06, 2009: Santhera Aligns Resources and Plans to Restructure Drug Discovery

June 30, 2009: Santhera's FJORD Phase IIb Study Demonstrates Efficacy of JP-1730/Fipamezole for the Treatment of Dyskinesia in Parkinson's Disease

June 26, 2009: Santhera Enters Agreement with Columbia University to Investigate Additional Potential of CatenaŽ in MELAS

June 24, 2009: Santhera and NIH Collaborate To Evaluate CatenaŽ in Primary Progressive Multiple Sclerosis

May 19, 2009: Santhera's US Phase III IONIA Trial in Friedreich's Ataxia Misses Primary Endpoint

April 27, 2009: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

April 22, 2009: Santhera Enrolls Last Patient in Phase IIb FJORD study with JP-1730/Fipamezole in Dyskinesia in Parkinson's Disease

April 03, 2009: Santhera Proposes Changes to its Board of Directors

March 20, 2009: Publication Highlights Potential of Santhera's Oral MC4-Receptor Antagonist Program for Treatment of Cancer Cachexia

February 27, 2009: Santhera 2008 Results (news kit)

February 27, 2009: Santhera Reports Financial Results 2008 and Successful First Product Launch

2008

December 11, 2008: Santhera Enrolls Last Patient in European Phase III Trial Evaluating SNT-MC17/Idebenone in Friedreich's Ataxia

November 19, 2008: CHMP Confirms Original Opinion on Santhera's SNT-MC17/Idebenone for Treatment of Friedreich's Ataxia

November 07, 2008: Santhera Presents Preclinical Data on Oral MC4 Receptor Antagonists for Treatment of Cancer Cachexia at AICR Research Conference

November 06, 2008: Santhera Raises CHF 15.9 Million in Private Placement with Strategic Investor Ares Life Sciences

October 31, 2008: Santhera Enrolls Last Patient in Pivotal US Phase III with SNT-MC17/Idebenone in Friedreich's Ataxia

October 10, 2008: Santhera Launches CATENAŽ in Canada

September 25, 2008: Publication in European Heart Journal Highlights Potential of Santhera's SNT-MC17/idebenone in Duchenne Muscular Dystrophy

August 22, 2008: Santhera's 2008 Interim Results Reflect Advances in Clinical Development and Preparation for First Product Launch

August 15, 2008: Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA

August 08, 2008: Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia

July 24, 2008: Santhera's Ongoing Studies Prevent CHMP Review under Small Patient Populations Guideline - Company Expects Negative CHMP Opinion on MAA for SNT-MC17/Idebenone in Friedreich's Ataxia

July 24, 2008: Santhera Receives First Product Approval: Health Canada Approves CatenaŽ for Treatment of Friedreich's Ataxia

May 28, 2008: Santhera Presents Efficacy Data of SNT-317 in Congenital Muscular Dystrophy at International Congress of Myology

April 21, 2008: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

April 11, 2008: Santhera Presents Efficacy Data of SNT-MC17 in DMD at AAN Annual Meeting

February 29, 2008: Santhera 2007 results (news kit)

February 29, 2008: Santhera Reports Financial Results and Significant Operational Progress for 2007

2007

November 29, 2007: Health Canada Accepts Santhera's Submission for Marketing Authorization of SNT-MC17 in Friedreich's Ataxia

November 12, 2007: Santhera Showcases Potential and Progress of its Clinical Development Pipeline

November 09, 2007: Santhera Starts Phase IIb Clinical Trial with JP-1730 in Dyskinesia in Parkinson's Disease

October 29, 2007: Santhera Reports Encouraging, First Data from Phase IIa Clinical Trial with SNT-MC17 in Duchenne Muscular Dystrophy

October 24, 2007: Santhera's CSO Thomas Meier Receives BioValley Award for Scientific and Entrepreneurial Merits

October 04, 2007: Swissmedic Accepts Santhera's Filing of SNT-MC17 in Friedreich's Ataxia

September 28, 2007: Santhera Announces Start of US Phase III Clinical Trial with SNT-MC17 in Friedreich's Ataxia and Provides Details on Study Design

September 21, 2007: Santhera to Seek Canadian Market Approval for SNT-MC17 in Friedreich's Ataxia

September 07, 2007: Publication in LANCET Neurology Highlights Potential of Santhera's SNT-MC17 for Friedreich's Ataxia

August 17, 2007: Santhera's 2007 Interim Results Reflect Increased Investment in Advanced Development Pipeline

August 16, 2007: European EMEA acceptance of Marketing Authorization Application filing for SNT-MC17 in Friedreich's Ataxia by Santhera

August 02, 2007: Santhera and Takeda Extend European Marketing Collaboration for SNT-MC17 into Duchenne Muscular Dystrophy

July 02, 2007: Santhera Licenses Omigapil for Treatment of Rare Neuromuscular Diseases

April 23, 2007: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

March 28, 2007: Santhera Announces Appointment of Cesare Mondadori as Head of Research

March 02, 2007: Santhera 2006 results (news kit)

March 02, 2007: Santhera Reports Successful 2006

March 01, 2007: Santhera Board Proposes the Election of Klaus Schollmeier to the Company's Board

January 31, 2007: Santhera Updates Development Strategy for SNT-MC17/idebenone in Friedreich's Ataxia in the US

January 31, 2007: Santhera Intends Early Filing in Europe for SNT-MC17/idebenone in Friedreich's Ataxia

2006

November 30, 2006: Santhera and Biozentrum Basel participate in the pan-European TREAT-NMD initiative to advance the treatment of rare neuromuscular diseases

November 24, 2006: Santhera announces exercise of over-allotment option

November 13, 2006: NIH and Santhera Announce Positive Results of Study with SNT-MC17/idebenone in Friedreich's Ataxia (FRDA)

November 03, 2006: Santhera prices IPO at CHF 90 per share and raises CHF 88.5 million

October 23, 2006: Santhera announces an Initial Public Offering and subsequent listing on the SWX Swiss Exchange

October 06, 2006: NIH Completes Collaborative Phase II Study with Santhera's compound SNT-MC17/idebenone in Friedreich's Ataxia (FRDA)

October 05, 2006: Santhera Raises up to EUR 15 million in Oversubscribed Series C Financing

September 26, 2006: Santhera Targets Third Indication - Leber's Hereditary Optic Neuropathy (LHON) - with its Lead Compound SNT-MC17/idebenone

September 22, 2006: Santhera Appoints MJ Roach as Vice President Marketing and Sales

September 15, 2006: Santhera Appoints New Board Directors

September 05, 2006: Santhera and Juvantia to Collaborate on Development of Phase II Product for Dyskinesia in Parkinson's Disease

January 03, 2006: Santhera Announces Management Buy-Out of the Graffinity Drug Discovery Technology Business

2005

December 20, 2005: Santhera Raises CHF 25 Million (Euro 16 Million) Via a Further Closing of its 2005 B Financing Round

December 15, 2005: Santhera starts European Phase III Study with its Lead Compound SNT-MC17 (idebenone) in Friedreich's Ataxia

November 02, 2005: Santhera and the NIH Collaborate to Evaluate SNT-MC17 in Friedreich's Ataxia

October 19, 2005: Santhera Targets New Indication with its Lead Compound

October 12, 2005: Cellzome and Santhera's business unit, Graffinity, awarded € 2.2 million grant from German Government

August 17, 2005: Biovitrum and Santhera sign an exclusive license and collaboration agreement for the development of DPP-IV inhibitors for the treatment of type 2 diabetes and other metabolic diseases

August 03, 2005: Santhera and Takeda Establish Collaboration to Develop and Market Idebenone (SNT-MC17) in Neuromuscular Disease

May 07, 2005: Santhera Presents at the International Congress of Myology

May 03, 2005: Santhera Pharmaceuticals Announces the Appointment of Barbara A. Heller as Chief Financial Officer

February 24, 2005: Santhera Reaches Milestone in Serono Drug Discovery Collaboration

2004

December 17, 2004: Santhera Pharmaceuticals AG Completes First Round of Financing Raising EURO 14 Million

November 30, 2004: Santhera Pharmaceuticals Announces the Appointment of Pierre Vankan, Ph.D. as Vice President, Drug Development and Global Project Management

October 07, 2004: Santhera Pharmaceuticals and Genzyme Enter Into Option and License Agreement for Discovery of Therapies for Muscle Diseases

September 08, 2004: GRAFFINITY PHARMACEUTICALS AG AND MYOCONTRACT AG MERGE TO FORM SANTHERA PHARMACEUTICALS AG