Santhera Pharmaceuticals Holding AG / Santhera Prepares for Pivotal Study with Omigapil
in Congenital Muscular Dystrophy processed and transmitted by Hugin AS. The issuer is
solely responsible for the content of this announcement.
Liestal, Switzerland, September 29, 2010 - Santhera Pharmaceuticals (SIX: SANN) informed
today about recent achievements and next steps in the clinical development program for
omigapil as potential first treatment of Congenital Muscular Dystrophy (CMD). This
severe, genetically determined neuromuscular disease frequently affects infants or young
children with life-threatening progressive muscle weakness. The preparation of the
further clinical development includes an expert meeting held this week in Bethesda,
Maryland, hosted by the US National Institute of Neurological Disorders and Stroke
(NINDS) and Cure CMD, a dedicated patient advocacy group.
Santhera is currently completing the remaining nonclinical development of omigapil
required for the use of the compound in pediatric patients with financial support from
the Association Française contre les Myopathies (AFM). Santhera plans to seek protocol
assistance and scientific advice from the US Food and Drug Administration and the
European Medicines Agency by early 2011. Both agencies have already granted orphan drug
designation to the program.
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