Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

Santhera Anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing Authorization Application for Raxone® in Duchenne Muscular Dystrophy


Posted on: 24 Jan 18

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.

# # #

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/5cf2ca84-9a28-4733-95bb-0afb9a820984

GlobeNewswire
globenewswire.com

Last updated on: 25/01/2018

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.