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Santhera expects CHMP opinion on its MAA for Raxone® early 2013(Thomson Reuters ONE via COMTEX) -- Santhera Pharmaceuticals Holding AG / Santhera expects CHMP opinion on its MAA for Raxone® early 2013 . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Liestal, Switzerland, November 16, 2012 - Santhera Pharmaceuticals (SIX: SANN) announced today that the opinion of the Committee for Medicinal Products for Human Use (CHMP) on its Marketing Authorization Application (MAA) for Raxone® in the treatment of Leber's Hereditary Optic Neuropathy (LHON) is expected to be obtained in early 2013. "We expected to obtain the CHMP's decision on our MAA for Raxone in LHON by the end of this year," said Thomas Meier, Santhera's CEO. "Further interaction with the CHMP and submission of additional information has resulted in a revised timeline for the procedure. We now expect that the CHMP will render an opinion on our application in early 2013." About Raxone® in LHON Santhera develops Raxone® (INN: Idebenone) in a number of mitochondrial and neuromuscular diseases, including as treatment for patients with LHON, a heritable genetic disease causing blindness. LHON typically presents in young adults, mostly men, as painless loss of vision in both eyes, leading to blindness within a few months of the onset of symptoms. Over 95% of patients harbor one of three pathogenic mutations of the mitochondrial DNA which cause a defect in the complex I subunit of the mitochondrial respiratory chain. This defect leads to decreased cellular energy (ATP) production, increased oxidative stress and retinal ganglion dysfunction which cause progressive loss of visual acuity and blindness. Idebenone, a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase is capable of transferring electrons directly onto complex III of the mitochondrial electron transport chain, thereby circumventing the complex I defect and restoring cellular energy levels. By this mechanism of bypassing complex I, which is affected in all three primary mtDNA mutations causing LHON, idebenone restores electron transport and cellular energy generation in retinal ganglion cells, promoting recovery of visual acuity. The efficacy of Raxone has been tested in a randomized, placebo controlled study and a number of open label cohort studies and case reports. * * * About Santhera Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focusedon the development and commercialization of innovative pharmaceutical products for the treatment of orphan neuromuscular and mitochondrial diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com. Raxone® and Catena® are trademarks of Santhera Pharmaceuticals. For further information, contact Thomas Meier, Chief Executive Officer Phone: +41 (0)61 906 89 64 [email protected] Disclaimer/Forward-looking statements This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward- looking statements. This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE HUG#1658834 SANN_2012_11_16 - http://hugin.info/137261/R/1658834/536887.pdf |