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

07-Dec-2010 - Switzerland

Santhera Pharmaceuticals announced 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.

https://www.bionity.com/en/news/127028/santhera-obtains-european-patent-for-use-of-omigapil-for-the-treatment-of-congenital-muscular-dystrophy.html