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
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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