Santhera Obtains US and Canadian Patents for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy
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Santhera Pharmaceuticals Holding AG /
Santhera Obtains US and Canadian Patents for Use of Omigapil for the Treatment
of Congenital Muscular Dystrophy
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Liestal, Switzerland, February 8, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today, that the United States Patent and Trademark Office and the
Canadian Intellectual Property Office granted patent protection for the use of
omigapil for the treatment of Congenital Muscular Dystrophy until 2027 and
2026, respectively. These patent grants follow shortly after a similar positive
decision was published by the European Patent Office. Congenital Muscular
Dystrophy is a group of severe, genetically determined neuromuscular diseases
frequently affecting infants or young children. No pharmacological therapy is
currently available or in advanced clinical development to help people suffering
from this life-threatening progressive muscle weakness.
The patent granted in Canada covers use of omigapil for the treatment or
prevention of muscular dystrophy especially congenital muscular dystrophies
resulting from laminin-alpha-2 deficiency as in the MDC1A form of Congenital
Muscular Dystrophy. The granted US patent covers specifically the treatment or
prevention of Ullrich congenital muscular dystrophy, Bethlem myopathy, or
intermediate clinical manifestations. Orphan drug designation was granted to the
program in 2008 by both the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) providing market exclusivity for 7 and 10 years
following marketing approval, respectively.
"The patents for omigapil in Congenital Muscular Dystrophy in the United States
and Canada complement our strong IP protection for this development program",
commented Thomas Meier, Chief Scientific Officer of Santhera. "The US and
Canadian patents further validate our in-house research and strengthens our
product opportunities in the field of rare neuromuscular diseases."
Santhera has completed the nonclinical development required for omigapil in
support of a clinical study. This work was funded by a research grant from the
French patient organization Association Française contre les Myopathies. The
Company is seeking scientific advice from key opinion leaders in Congenital
Muscular Dystrophy and will discuss the clinical development program with the
FDA and EMA. The start of a Phase II/III program is anticipated for late 2011.
About Congenital Muscular Dystrophy
Congenital Muscular Dystrophy refers to a wide variety of inherited
neuromuscular conditions characterized by different forms of progressive loss of
muscle tissue. Severe forms can affect newborns or young children with life-
threatening progressive muscle weakness ("floppy infant syndrome").
Complications associated with the disorder cause immobility at young age and
early mortality. Patients suffer from loss of body weight, skeletal deformations
and respiratory distress resulting in immobility at young age and early
mortality. A recent epidemiological estimate approximates a prevalence of 0.89
per 100,000. No pharmacological therapy is currently available or in advanced
clinical development. Treatment options are confined to ventilatory support and
orthopedic surgery for scoliosis as well as supplementary nutrition to avoid
malnutrition.
Santhera focuses on distinct subtypes of Congenital Muscular Dystrophy caused by
collagen-VI (Ullrich, Bethlem Myopathy) or laminin-alpha-2 (MDC1A) deficiency.
Both subtypes are associated with mitochondrial dysfunction and muscle cell
apoptosis. In vivo studies show that omigapil, an anti-apoptotic compound,
inhibits cell death and reduces body weight loss and skeletal deformation while
increasing locomotive activity and protecting from early mortality [1].
Reference
[1] Erb M. et.al. (2009). Omigapil ameliorates the pathology of muscle dystrophy
caused by laminin-alpha-2 deficiency. Journal of Pharmacology and Experimental
Therapeutics 331: 787-795
* * *
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. 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;
Omigapil Patent:
http://hugin.info/137261/R/1484789/420022.pdf
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[HUG#1484789]
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Datum: 08.02.2011 - 07:01 Uhr
Sprache: Deutsch
News-ID 51173
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contact information:
Town:
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