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Brain injury drug granted orphan status

The European Commission has granted orphan drug designation to NeuroVive's NeuroSTAT for moderate to severe traumatic brain injury

Following a positive opinion from the European Medicines Agency (EMA) in July, the European Commission has granted Orphan Medicinal Product status to NeuroVive Pharmaceutical's NeuroSTAT for the treatment of patients with moderate to severe traumatic brain injury (TBI).

In TBI, the blood-brain barrier is opened. It is the leading cause of death in men between the ages of 15 and 45 and it disables almost 100,000 men and women in Europe each year. No currently approved drug can reduce brain damage that results from TBI. 

NeuroSTAT is a novel Cremophor EL-free and alcohol-free formulation of cyclosporine-A. Cyclosporine-A strengthens mitochondrial membranes, allowing the mitochondria to take up and store more calcium without being damaged. This ensures that they can continue to produce energy and reduces the risk of nerve cell death, therefore protecting brain cells.

"NeuroSTAT cyclosporine has been shown to protect energy-producing mitochondria and counteract brain damage in TBI models. Our clinical development programme will begin to test its efficacy in patients," said Eskil Elmér, chief scientific office of NeuroVive.

"The Commission's decision is an affirmation of our development strategy," commented Mikael Brönnegård, chief executive officer of NeuroVive. "From a market point of view, the possibility of ten years exclusivity from registration in the EU is extremely important to NeuroSTAT's continued development in neuroprotection and it creates the conditions for more rapid commercialisation. Orphan drug designation gives us access to important regulatory assistance which will greatly facilitate the development of neuroprotective therapy for acute treatment of patients with moderate and severe traumatic brain injury."

NeuroVive owns global patent rights for the protection of nerve cells with cyclosporine in cases of acute neurological injury. The company also holds exclusive patent rights to a cyclosporine-A-based cremophore and ethanol-free lipid emulsion.

The orphan drug designation comes just weeks after US-based Maas Biolab reduced its ownership of NeuroVive by more than 2.2 million shares, taking it from 51.2 per cent to 36.4 per cent. Maas, which holds US Food and Drug Administration (FDA) orphan drug designation for cyclosporine to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's/motor neurone disease) and world patents for cyclosporine neuroprotection against chronic neurological diseases, remains NeuroVive's largest single shareholder.

11th October 2010

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