Santhera launches Raxone® in its first EU market
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Santhera Pharmaceuticals Holding AG /
Santhera launches Raxone® in its first EU market
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Liestal, Switzerland, October 1, 2015 - Santhera Pharmaceuticals (SIX: SANN)
announces that it is today launching Raxone(®) for the treatment of Leber's
Hereditary Optic Neuropathy (LHON) in Germany, its first and largest EU market.
LHON is a rare inherited mitochondrial disease that usually leads rapidly to
profound and permanent blindness.
"The introduction of Raxone in Germany is a major step forward for LHON patients
who now have an effective treatment option" said Giovanni Stropoli, Santhera's
Chief Commercial Officer for Europe. "We are particularly proud as Raxone is
also the first approved treatment for any mitochondrial disease, a therapeutic
area which is in the focus of our Company. Germany is our first and largest EU
market but product availability is anticipated in additional countries in the
immediate future."
"Mitochondrial disease treatments have been elusive for a long time. The
availability of Raxone for patients with LHON is changing the paradigm and also
raises hopes for other mitochondrial disorders," said Thomas Klopstock, MD,
Professor of Neurology at the University of Munich, LHON researcher and
coordinator of the German network for mitochondrial disorders, mitoNET. "LHON
patients usually become blind in young adulthood, which entails not only a
personal and medical, but also a socioeconomic burden. With Raxone, we can now
offer a treatment option which greatly improves the chances for significant
recovery of visual acuity."
"As an organization representing the interests of patients affected with LHON,
we are very excited that an approved medication is finally available for the
treatment of this devastating disease," emphasized Claus-Peter Eisenhardt,
President of the German Patient Advocacy of patients with mitochondrial
diseases, within the German Society of Muscular Diseases (DGM). "We are grateful
to the European regulatory authorities, who, after careful evaluation of all
available data, approved Raxone and made LHON a treatable disease."
Raxone is an oral medication, authorized at a daily dose of 900 mg (given as 2
tablets three times a day with food), for the treatment of visual impairment in
adolescent and adult patients with LHON. Treatment should be initiated and
supervised by a physician with experience in LHON. Efficacy data come from
Santhera's randomized, placebo-controlled RHODOS trial and from the open label
Expanded Access Program, which together have demonstrated that vision loss can
be mitigated or reversed in patients treated with Raxone.
About Leber's Hereditary Optic Neuropathy and the Therapeutic Use of Raxone
LHON is a heritable genetic disease causing blindness. The disease presents
predominantly in young, otherwise healthy adult males as rapid, painless loss of
central vision, usually leading to permanent bilateral blindness within a few
months of the onset of symptoms. About 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 reactive oxygen species
(ROS) production and retinal ganglion cell dysfunction, which cause progressive
loss of visual acuity and blindness.
Raxone (idebenone), a synthetic short-chain benzoquinone and a cofactor for the
enzyme NAD(P)H:quinone oxidoreductase (NQO1), circumvents the complex I defect,
reduces and scavenges ROS, restores cellular energy levels in retinal ganglion
cells and promotes recovery of visual acuity.
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(®) is authorized in the European Union for the
treatment of Leber's Hereditary Optic Neuropathy (LHON). Santhera is developing
Raxone(®)/Catena(®) in two additional indications, Duchenne Muscular Dystrophy
(DMD) and primary progressive Multiple Sclerosis (ppMS), and omigapil for
Congenital Muscular Dystrophy (CMD), all areas of high unmet medical need. For
further information, please visit the Company's website www.santhera.com.
Raxone(®) and Catena(®) are trademarks of Santhera Pharmaceuticals.
For further information, contact:
Thomas Meier, PhD, Chief Executive Christoph Rentsch, Chief Financial
Officer Officer
Phone +41 61 906 89 64 Phone +41 61 906 89 65
thomas.meier(at)santhera.com christoph.rentsch(at)santhera.com
US investor contact: US Public Relations contact:
Hans Vitzthum, LifeSci Advisors, LLC Deanne Eagle, Planet Communications
Phone +1 212 915 2568 Phone +1 917 837 5866
hans(at)lifesciadvisors.com deanne(at)planetcommunications.nyc
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.
# # #
News release Launch Germany:
http://hugin.info/137261/R/1955888/712314.pdf
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Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
[HUG#1955888]
Unternehmensinformation / Kurzprofil:
Datum: 01.10.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 423908
Anzahl Zeichen: 7243
contact information:
Town:
Liestal
Kategorie:
Business News
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