Santhera Anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing Authorization
Application for Raxone® in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals Holding AG /
Santhera Anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing
Authorization Application for Raxone® in Duchenne Muscular Dystrophy
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Source: Globenewswire
Liestal, Switzerland, January 24, 2018 - Santhera Pharmaceuticals (SIX: SANN)
announces that on January 23 it had an oral explanation at the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
in relation to the re-examination of its Marketing Authorization Application
(MAA) for Raxone® (idebenone) in Duchenne muscular dystrophy (DMD). The company
now anticipates that the CHMP will maintain its original position to issue a
negative opinion on Santhera's MAA filed as Type II variation of its existing
marketing authorization for Leber's hereditary optic neuropathy (LHON).
Santhera will provide further update on Friday, January 26, as originally
announced.
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, Liechtenstein and Israel for the treatment of Leber's
hereditary optic neuropathy (LHON). Santhera is currently conducting the Phase
III SIDEROS trial with Raxone in patients with Duchenne muscular dystrophy in
respiratory function decline. 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:
public-relations@santhera.com or
Eva Kalias, Vio Consult
Phone: +41 78 671 98 86
kalias@vioconsult.com
For Investors:
investor-relations@santhera.com or
Christoph Rentsch, Chief Financial Officer
Hans Vitzthum, LifeSci Advisors
Europe: +41 61 906 89 65
US:
+1 212 915 2568
christoph.rentsch@santhera.com
hans@lifesciadvisors.com
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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Mitteilung Appeal:
http://hugin.info/137261/R/2163467/832242.pdf
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Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
http://www.santhera.com