Santhera Withdraws Marketing Authorization Application for Raxone® in LHON
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Santhera Withdraws Marketing Authorization Application for Raxone® in LHON
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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(at)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.
Withdrawal:
http://hugin.info/137261/R/1687236/553279.pdf
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1687236]
Unternehmensinformation / Kurzprofil:
Datum: 22.03.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 242173
Anzahl Zeichen: 5805
contact information:
Town:
Liestal
Kategorie:
Business News
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