Sygnis Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis

April 24, 2008 - SYGNIS Pharma AG, today announced that it has received Orphan Drug designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis (ALS). This follows the positive recommendation that SYGNIS received from the EMEA in February.

Orphan Drug designation can be granted for a product that is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union. During the development phase certain incentives are given to the developing company to facilitate the product's registration and market authorization. These incentives include reductions in fees, an accelerated registration procedure and a period of up to 10 years market exclusivity once the product is approved.


ALS is a progressive neurodegenerative disease caused by the degeneration of nerve cells innervating skeletal muscles and affects an estimated 50,000 to 100,000 people in the industrialized nations. Patients with ALS suffer from progressive muscle wasting throughout their bodies resulting in increasing disabilities and their lifespan is cut short. Death in ALS patients normally occurs within only a few years after diagnosis and there are currently only inadequate therapies available.