19 January 2018
Santhera Plans to Announce Regulatory Feedback for Raxone® in DMD and 2017 Preliminary Key Financial Figures
Liestal, Switzerland, January 19, 2018 – Santhera Pharmaceuticals (SIX: SANN) expects to announce feedback from the CHMP on its Marketing Authorization Application (MAA) for Raxone® in Duchenne muscular dystrophy (DMD) on January 26, 2018, and will publish the Company’s preliminary key financial figures for 2017 on January 29, 2018.
Announcement of CHMP opinion on MAA for Raxone® in DMD expected for January 26, 2018
Santhera expects to receive an opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its MAA filed as Type II extension application for Raxone® (idebenone) in DMD by January 26, following a re-examination procedure. Santhera expects to announce the CHMP opinion on January 26, 2018, at 07:00 hrs CET. On the same day, at 14:00 hrs CET, Thomas Meier, PhD, CEO of Santhera, will hold an investor conference call to discuss the outcome.
Announcement of 2017 Key Financials on January 29, 2018
Santhera will release its preliminary key financial figures for 2017 and provide a corporate update on January 29, 2018, at 07:00 hrs CET. In an investor conference call scheduled the same day at 14:00 hrs CET, Thomas Meier, PhD, CEO of Santhera, will discuss the key financials and the development of the business.
The 2017 Annual Report with full financial results will be published on March 20, 2018, at 07:00 hrs CET.
Access to conference calls
Participants can access either conference call by dialing one of the following numbers about 10 minutes before the call is due to start:
+41 (0)58 310 50 00 (Europe)
+44 (0)207 107 0613 (UK)
+1 (1)631 570 5613 (USA)
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, Liechtenstein and Israel 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 another product – omigapil – for congenital muscular dystrophy (CMD), both also 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 please contact:
Eva Kalias, Vio Consult
Phone: +41 78 671 98 86
Christoph Rentsch, Chief Financial Officer Hans Vitzthum, LifeSci Advisors
Europe: +41 61 906 89 65 US: +1 212 915 2568
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.
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