Analyst Reports

CUV announced that their afamelanotide product has been accepted by two health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light.

NSV is a de-pigmenting disease that affects c10mn persons in the US and EU. CUV’s afamelanotide is being evaluated as a combination therapy with narrowband UVB light therapy in two clinical studies in patients with NSV. In early Phase II trial results presented at a recent conference, the NB-UVB plus afamelanotide group showed earlier onset of repigmentation compared to controls.

CUV has released: 1) clinically impressive interim Phase II Vitiligo trial results; and 2) US FDA agreement to be allowed to conduct a Phase III study in erythropoietic protoporphyria (EPP).

1H12 – a number of opportunities

CUV announced that it has submitted a marketing authorisation application (MAA) for its drug afamelanotide (16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of afamelanotide as a prophylactic treatment in adult patients with erythropoietic protoporphyria (EPP), a rare disease which causes absolute intolerance of patients’ skin to light. Approval would allow CUV to market afamelanotide in all 27 European Union member states as well as Norway, Iceland and Lichtenstein. This news is in line with our timelines. We expect a MAA decision in the EU in CY12. The EMA aims to complete a MAA review within 210 days after submission. Read the full report by downloading the PDF here.

Positive results in the second Phase III study of Clinuvel’s Scenesse (afamelanotide), a photoprotective drug for treating the orphan condition erythropoietic protoporphyria (EPP), put the drug on track for an EU approval filing, due shortly, and could be a contributory factor in the FDA’s decision to conduct a Phase III trial. To read this full report, download the attached PDF.

  The latest analyst coverage of Clinuvel from Nomura has just been released. To view this, click here: CUV announces positive results from pivotal European Phase III study.

Clinuvel demonstrates positive treatment effect of afamelanotide in US Phase II study Analyses from US confirmatory study demonstrated a dramatic improvement in Quality of Life from afamelanotide 16mg in the orphan disease erythropoietic protoporphyria (EPP).

Considerable upside from potentially successful NSV trials