Kinesys Consulting Ltd is pleased to announce that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to Soligenix’ recombinant modified ricin toxin A-chain subunit, the active pharmaceutical ingredient in RiVax®, for the prevention of ricin poisoning. RiVax® has previously been granted orphan drug designation from the US Food and Drug Administration (FDA).
Kinesys has secured this designation on behalf of its US partner Soligenix, Inc., New Jersey.
“We are extremely pleased to have received European orphan drug designation for the RiVax® program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, Inc. “This EU orphan designation, combined with our US orphan designation, positions this biodefense program for a potentially accelerated global regulatory product development pathway to address this unmet need. RiVax® has shown up to 100% protection against aerosolized ricin exposure in non-human primates and safety in humans and we look forward to further developing our thermostable formulation for human use.”
For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com