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Drug Candidate Receives Orphan Drug Designation

Non Regulatory

The text below is a translation of a Swedish press release.

BioArctic Neuroscience develops treatments to help victims of spinal cord injury.

The European Medicines Agency (EMA) has announced that the drug candidate that BioArctic Neuroscience is developing for the treatment of traumatic spinal cord injury receives positive opinion Orphan Drug designation. Medicines for rare diseases so-called ´orphan´ medicinal products are intended for the treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10 000 people in the European Union.

BioArctic develops a drug to obtain a successful neurosurgical treatment of patients with spinal cord injury. This development is in collaboration with highly innovative Swedish research at the Karolinska Institut, the Karolinska University Hospital in Stockholm and Ångström laboratory in Uppsala.

This is an enormous recognition that EMA has recommended BioArctic s drug candidate to be designated as Orphan Drug. It means support during the development and 10 years market exclusivity after an approval. There is a lack of treatments for severe traumatic spinal cord injury, which is a devastating condition leading to markedly impaired life quality and personal suffering and very high economical costs to the society, says Dr. Pär Gellerfors, CEO of BioArctic Neuroscience.

The drug candidate is a growth factor in combination with a biodegradable device. It has demonstrated very promising effects in an animal model of complete spinal cord injury. The drug will be used during neurosurgical procedures to recreate a functional spinal cord.

For more information contact

BioArctic Neuroscience AB
Pär Gellerfors, CEO
telephone +46-(0)8-695 6931