Analyst Reports

Nomura Quick Note: "Launches US Phase III trial for EPP treatment"

23 May 2012
Clinuvel Pharmaceuticals (CUV) has started its confirmatory Phase III US study of the novel drug afamelanotide, for the treatment of erythropoietic protoporphyria (EPP), a rare light intolerance disorder. The Phase III trial protocol has been designed in close consultation with the US Food and Drug Administration (FDA).

Nomura Quick Note: "Afamelanotide receives approval in Switzerland"

26 Apr 2012
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.

Nomura Update "Considerable upside should NSV trials be successful"

27 Mar 2012
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.

Nomura Quick Note: "Vitiligo and EPP opportunities progress"

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).

Nomura Update "We believe the Vitiligo market is currently underserved"

27 Feb 2012
1H12 – a number of opportunities

Nomura Quick Note: "MAA review should complete by start 4QCY12"

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.

Edison QuickView: Positive in Phase III

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.

Nomura Quick Note: "Positive result from pivotal EU Phase III study"

20 Dec 2011
  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.

Nomura Update "CUV's statistically significant EPP results"

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).

Nomura Update "Vitiligo - addressing a large unmet need"

Considerable upside from potentially successful NSV trials
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Investors' Blog Posts

Earlier today we announced that two health insurers in Switzerland had agreed to reimburse SCENESSE® (afamelanotide) for the rare disease...

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Investor Spotlight

Contents: INTRODUCTION ERYTHROPOIETIC PROTOPORPHYRIA (EPP) NONSEGMENTAL VITILIGO (NSV) CLINUVEL BUSINESS MODEL CORPORATE MILESTONES CHAIR's LETTER MANAGING DIRECTOR’S REPORT FINANCIALS ADDITIONAL INFORMATION REQUIRED BY THE ASX MARKET PERFORMANCE GLOSSARY ...

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Vitiligo is a skin disorder which causes the loss of pigment - melanin - in the skin. Though it affects around 45 million people worldwide,...

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On 31 January 2012 Swiss TV channel Telezueri aired a report on erythropoietic protoporphyria (EPP), a rare genetic disorder which causes ab...

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