Rayos – known as Lodotra in Europe where it has been approved since 2009 – is a 'circadian cytokine modulator' that mediates its therapeutic benefits through the glucocorticoid prednisone, the release of which is controlled using SkyPharma’s Geoclock technology.
In a note to investors Singer Capital Markets analyst Shawn Manning predicted that the drug could generate annual sales in the US of $50m in the next five years, 3 per cent of which would go to SkyePharma as a royalty payment.
SkyePharma is also set to earn production fees for Rayos, which will made at the facility in Lyon, France that the firm leased to German contract manufacturing group Aenova in August 2011.
The US approval comes just weeks after European regulators approved flutiform – an asthma treatment that uses SkyPharma’s SkyeDry delivery technology that the firm is developing in Europe with Mundipharma International.