Home » Business News » 2010 » December » December 7, 2010

Santhera Obtains European Patent for Use of Omigapil for the Treatment of Congenital Muscular Dystrophy

December 7, 2010 - London

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].



[1] Erb M. (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


Catena® is a trademark of Santhera Pharmaceuticals.



For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 64


Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47



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.

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


Comment on this story