Santhera Obtains European Patent for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy
(Thomson Reuters ONE) -
Santhera Pharmaceuticals Holding AG /
Santhera Obtains European Patent for Use of Omigapil for the Treatment of
Congenital Muscular Dystrophy
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, December 7, 2010 - Santhera Pharmaceuticals (SIX: SANN)
announced today that the European Patent Office granted patent protection for
the use of omigapil for the treatment of Congenital Muscular Dystrophy until
2026. This group of severe, genetically determined neuromuscular diseases
frequently affects infants or young children with life-threatening progressive
muscle weakness.
The patent granted covers 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 patent
protection in Europe will last until 2026. In the United States, a similar
patent is pending. In 2008, both the European Medicines Agency (EMA) and the US
Food and Drug Administration (FDA) granted orphan drug designation providing
market exclusivity for 10 and 7 years, respectively, following marketing
approval.
"The European patent for omigapil in Congenital Muscular Dystrophy validates our
in-house research and strengthens our strategic position in the field of rare
neuromuscular diseases", commented Thomas Meier, Chief Scientific Officer of
Santhera.
With a grant from the patient organization Association Française contre les
Myopathies (AFM), Santhera completed the nonclinical development required for
omigapil in support of a clinical study. Santhera is collaborating with
international experts for the development of a clinical trial protocol and will
seek protocol assistance and scientific advice from the FDA and the EMA in early
2011. 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 specialty niche products for
the treatment of neurodegenerative and neuromuscular diseases, areas 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;
News release Omigapil patent:
http://hugin.info/137261/R/1469584/406899.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1469584]
Unternehmensinformation / Kurzprofil:
Datum: 07.12.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 49453
Anzahl Zeichen: 6613
contact information:
Town:
Liestal
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 396 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Santhera Obtains European Patent for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy"
steht unter der journalistisch-redaktionellen Verantwortung von
Santhera Pharmaceuticals Holding AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
