Santhera Pharmaceuticals Holding AG: Santhera Receives US Patent for
Fipamezole in the Treatment of Neurodegenerative Diseases
Santhera Pharmaceuticals Holding AG / Santhera Receives US Patent for
Fipamezole in the Treatment of Neurodegenerative Diseases . Processed and
transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely
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Liestal, Switzerland, March19, 2014 - Santhera Pharmaceuticals (SIX:SANN)
announced today that the United States Patent and Trademark Office has issued
a Notice of Allowance for a Santhera patent which protects the use of the
oromucosal administration route for fipamezole. The US patent 8,653,122, which
provides an exclusivity period until 2027, is crucial for the commercial
exploitation of fipamezole in the field of neurodegenerative diseases.
Santhera has global rights to fipamezole and has previously published
promising data of its Phase IIb clinical trial in the treatment of
levodopa-induced dyskinesia in Parkinson's disease.
The US patent claims the use of fipamezole via the oromucosal route of
administration, which is essentially the only method of administration that
achieves sufficient plasma levels of the drug and that is suitable for
long-term treatment. Santhera previously received notice of allowance for
equivalent patents in the EU and most other important markets worldwide.
Thomas Meier, Chief Executive Officer of Santhera, commented: "This US patent
now completes the patent protection estate for the fipamezole program and
allows the commercial exploitation of fipamezole as potential treatment of
neurodegenerative diseases, most notably of levodopa-induced dyskinesia in
Parkinson's disease. As Santhera is mainly focusing on the registration of
Raxone^®/Catena^® in Leber's Hereditary Optic Neuropathy, fipamezole is
currently available for licensing."
Fipamezole is an innovative and highly selective adrenergic alpha-2 receptor
antagonist, perceived by clinicians to be one of the most promising drug
candidates for the treatment of levodopa-induced dyskinesia in Parkinson's
disease, the second most common and a severely debilitating neurodegenerative
disorder. Santhera demonstrated in a Phase IIb clinical trial that oromucosal
fipamezole has the potential to safely and effectively reduce levodopa-induced
dyskinesia and daily "off" time without exacerbation of parkinsonism .
 LeWitt P., et al (2012). Randomized clinical trial of fipamezole for
dyskinesia in Parkinson disease (FJORD study). Neurology 79:163-169.
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, such as Leber's Hereditary Optic Neuropathy, Duchenne
Muscular Dystrophy and primary progressive Multiple Sclerosis, all of them
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 61 906 89 64
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
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any contract or investment decision. The Company disclaims any obligation to
update these forward-looking statements.
News release US patent
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Source: Santhera Pharmaceuticals Holding AG via Globenewswire
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Santhera Pharmaceuticals Holding AG
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