Clinuvel Pharmaceuticals (CUV: $11.20) has received clearance from the EMA for its Scenesse product for the treatment of EPP to be used up to six times a year, from the current four injection limit. This brings the guidance in line with the US.
The market for EPP continues to grow for Clinuvel. In the last financial year the product has been launched in two additional countries in Europe, and it has increased the treatment centres in the US to 104, with 100 insurers covering the treatment. The existing specialty treatment centres will also serve as a distribution network for the application in Vitiligo with Scenesse, with the Phase III program currently underway.
Scenesse for the treatment of Vitiligo provides, for the first time, a therapy that is effective in patients with extensive affected areas, according to physicians in the current Phase III study. Data emerging from the first Phase III study indicates that the therapy is effective, with patient satisfaction recorded from the outcomes. This includes in patients where topical therapies have not worked, and where previous treatments outcomes with standard-of-care have regressed.
Bioshares recommendation: Buy
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