Santhera Obtains US Patent for Use of Catena® in the Treatment of Muscular Dystrophies
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Santhera Pharmaceuticals Holding AG /
Santhera Obtains US Patent for Use of Catena® in the Treatment of Muscular
Dystrophies
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Liestal, Switzerland, August 24, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today that the United States Patent and Trademark Office granted
patent protection for the use of idebenone (brand name Catena®) in the treatment
of Duchenne Muscular Dystrophy and other muscular dystrophies. The patent in the
United States is supplemented by a similar patent in the European Union granted
in 2010.
The patent granted covers the treatment or prevention of weakness and loss of
skeletal muscle tissue as well as cardiomyopathy associated with certain forms
of muscular dystrophies including Duchenne Muscular Dystrophy, one of the most
common and devastating types of muscle loss. The patent protection in the United
States lasts until 2027. In Europe, a similar patent has been granted in 2010.
In early 2007, both the European Medicines Agency and the US Food and Drug
Administration granted orphan drug designation for idebenone in Duchenne
Muscular Dystrophy providing for seven and ten years, respectively, of market
exclusivity following approval.
"The patent for Catena® in Duchenne Muscular Dystrophy is an important
achievement in our efforts to develop and eventually commercialize the drug in
the United States. The US patent extends the IP protection considerably beyond
the market exclusivity that will go together with the orphan drug status",
commented Thomas Meier, Chief Scientific Officer of Santhera.
Catena® is currently being investigated in Duchenne Muscular Dystrophy in a
pivotal Phase III trial (the DELOS trial) with study centers enrolling patients
in Europe and the United States. The primary endpoint of this 12-month, double-
blind, placebo-controlled study is the change in respiratory function measured
by peak expiratory flow. Additional respiratory parameters, muscle strength and
motor function tests as well as quality of life assessments are secondary
efficacy variables.
* * *
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 severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is
marketed in Canada. Catena® is currently under review for marketing
authorization by the European Medicine Agency as first therapy for patients
suffering from Leber's Hereditary Optic Neuropathy. For further information,
please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals
For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 64
thomas.meier(at)santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach(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.
--- End of Message ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
Duchenne US Patent:
http://hugin.info/137261/R/1540047/470961.pdf
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originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1540047]
Unternehmensinformation / Kurzprofil:
Datum: 24.08.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 58586
Anzahl Zeichen: 5194
contact information:
Town:
Liestal
Kategorie:
Business News
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