ReNeuron's stem cell therapy wins orphan status
WORLD NEWS | AUGUST 29, 2013
There was good news for ReNeuron this week as regulators on both sides of the Atlantic awarded its eye disease stem cell therapy orphan drug designation.
Both the European Commission and US Food and Drug Administration have classed ReN003 an orphan drug for the treatment of retinitis pigmentosa, a group of hereditary progressive eye diseases that damage retinal cells and cause sight loss, which affect about four in 10,000 people in the EU and US.
This is very good news for ReNeuron, given that treatments with this designation benefit from significant commercial and regulatory advantages such as market exclusivity for 10 years from approval in the disease concerned, against other treatments offering no greater therapeutic advantage.
ReNeuron chief executive Michael Hunt said he is "delighted" with the move.
“Orphan status diseases are an increasing area of therapeutic and commercial focus by the mainstream pharmaceutical industry due to the distinct regulatory and market exclusivity advantages that Orphan Drug Designation confers".
“This fact bodes well for the commercial potential of our ReN003 therapy," he noted.
The UK group said it is expecting to file applications for an initial Phase I/II clinical trial with ReN003 in the UK and the US in the middle part of 2014.
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