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     419  0 Kommentare Santhera's Raxone® Receives First Positive EAMS Scientific Opinion from UK's MHRA in Duchenne Muscular Dystrophy - Seite 2

    About the UK Early Access to Medicines Scheme (EAMS)
    The UK's industry-sponsored EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need. Under the scheme, the MHRA provides a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made. The opinion lasts for a year and can be renewed. The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.

    About Santhera
    Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases. Santhera's lead product Raxone® (idebenone) is authorized in the European Union, Norway, Iceland and Liechtenstein for the treatment of Leber's hereditary optic neuropathy (LHON). For Duchenne muscular dystrophy (DMD), Santhera has filed a Marketing Authorization Application in the European Union and Switzerland for DMD patients with respiratory function decline who are not taking glucocorticoids. In collaboration with the U.S. National Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing Raxone® in a third indication, primary progressive multiple sclerosis (PPMS), and omigapil for congenital muscular dystrophy (CMD), all areas of high unmet medical need. For further information, please visit the Company's website www.santhera.com.

    Raxone® is a trademark of Santhera Pharmaceuticals.

    For further information, contact:
    Thomas Meier, PhD, Chief Executive Officer        Christoph Rentsch, Chief Financial Officer
    Phone +41 61 906 89 64                                      Phone +41 61 906 89 65
    thomas.meier@santhera.com                              christoph.rentsch@santhera.com

    Sue Schneidhorst, Head Group Communications
    Phone +41 61 906 89 26
    sue.schneidhorst@santhera.com

    US investor contact                                           US Public Relations contact
    Hans Vitzthum, LifeSci Advisors, LLC                  Chris Welsh, Consilium Strategic Communications
    Phone +1 212 915 2568                                       Phone +1 646 586 2113
    hans@lifesciadvisors.com                                  santhera@consilium-comms.com

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