Santhera expects CHMP opinion on its MAA for Raxone® early 2013
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Santhera expects CHMP opinion on its MAA for Raxone® early 2013
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Liestal, Switzerland, November 16, 2012 - Santhera Pharmaceuticals (SIX: SANN)
announced today that the opinion of the Committee for Medicinal Products for
Human Use (CHMP) on its Marketing Authorization Application (MAA) for Raxone® in
the treatment of Leber's Hereditary Optic Neuropathy (LHON) is expected to be
obtained in early 2013.
"We expected to obtain the CHMP's decision on our MAA for Raxone in LHON by the
end of this year," said Thomas Meier, Santhera's CEO. "Further interaction with
the CHMP and submission of additional information has resulted in a revised
timeline for the procedure. We now expect that the CHMP will render an opinion
on our application in early 2013."
About Raxone® in LHON
Santhera develops Raxone® (INN: Idebenone) in a number of mitochondrial and
neuromuscular diseases, including 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 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 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 mtDNA
mutations causing LHON, idebenone restores electron transport and cellular
energy generation in retinal ganglion cells, promoting recovery of visual
acuity.
The efficacy of Raxone has been tested in a randomized, placebo controlled study
and a number of open label cohort studies and case reports.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focusedon 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® and Catena® are trademarks of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 (0)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.
SANN_2012_11_16:
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Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 16.11.2012 - 17:35 Uhr
Sprache: Deutsch
News-ID 204691
Anzahl Zeichen: 4835
contact information:
Town:
Liestal
Kategorie:
Business News
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