Santhera Withdraws Marketing Authorization Application for Raxone® in LHON

(Thomson Reuters ONE via COMTEX) -- Santhera Pharmaceuticals Holding AG / Santhera Withdraws Marketing Authorization Application for Raxone® in LHON . Processed and transmitted by Thomson Reuters ONE.

The issuer is solely responsible for the content of this announcement.

Liestal, Switzerland, March 22, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today its decision to withdraw, for strategic reasons, the Marketing Authorization Application (MAA) for Raxone® as a potential therapy for Leber's Hereditary Optic Neuropathy (LHON). Santhera now plans to file a new application based on emerging clinical evidence supporting the efficacy of Raxone® in the treatment of LHON. This strategy is expected to increase the probability of a successful MAA outcome and is contingent on the availability of sufficient financial resources or on the outcome of ongoing licensing and M&A discussions.

Thomas Meier, Chief Executive Officer of Santhera, commented: "We initially planned to request re-examination of the previous CHMP opinion on our MAA in LHON. However, in view of emerging clinical evidence of efficacy, which the EMA confirmed cannot be considered in a re-examination procedure, we have decided to withdraw the MAA and to initiate a new procedure including this new evidence. Supported by external expert clinical and regulatory advice, we believe that this will allow us to address adequately the points raised by the CHMP in their opinion and increase the probability of an ultimately successful outcome." As indicated in late February 2013, Santhera continues to explore strategic and financing options including product licensing for Raxone® in LHON and the possibility of a merger or acquisition. In addition, Santhera anticipates convening a Shareholders' meeting in late April/early May 2013 to present the strategic options available and to allow a decision to be reached on the future direction of the Company.

About Raxone® in LHON Santhera develops Raxone® 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 cell 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 (NQO1) 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 mitochondrial DNA mutations causing LHON, idebenone supports electron transport and cellular energy generation in retinal ganglion cells, thereby promoting recovery of visual acuity.

The efficacy of Raxone® has been tested in a randomized, placebo controlled study and in a number of open label cohort studies and case reports by independent academic experts.

* * * 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 neuromuscular and mitochondrial diseases, areas of high unmet medical need with no current therapies. For further information, please visit www.santhera.com.

Raxone® is a trademark of Santhera Pharmaceuticals.

For further information, contact Thomas Meier, Chief Executive Officer Phone: +41 61 906 89 64 thomas.meier@santhera.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.

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#1687236 Withdrawal - http://hugin.info/137261/R/1687236/553279.pdf

[ Back To Technology News's Homepage ]