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Clinuvel and German National Association of Statutory Health Insurance Funds reach agreement on Scenesse pricing.

M2 EQUITYBITES-April 12, 2017-Clinuvel and German National Association of Statutory Health Insurance Funds reach agreement on Scenesse pricing


Clinuvel Pharmaceuticals Ltd (ASX: CUV) has reached an agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the pricing of Clinuvel's drug Scenesse (afamelanotide 16mg) for the treatment of erythropoietic protoporphyria (EPP) patients, the company disclosed on Wednesday.

The Australia-based company had been in mandatory 'negotiation' with GKV-SV since August last year. As per the German Pharmaceuticals Market Reorganisation Act (AMNOG), a pricing agreement was reached after an Arbitration Board was called and the board's outcome is legally binding for all state insurers in the country.

Scenesse is approved in Europe as an orphan medicinal product for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with EPP. EPP is a poorly characterised and an ultra-rare metabolic disorder which causes severe phototoxic and anaphylactoid reactions in patients. It is believed that the disease affects between 500 and 1,090 patients in Germany.

Clinical studies and use of the drug over the last decade have revealed that Scenesse helps to improve life for EPP patients. These improvements include the loss of their prodromal reactions, being able to gradually expose their skin to light sources and participating in daily activities, something that had been impossible prior to treatment.

The company received approval from the European Medicines Agency (EMA) for Scenesse indicated for the treatment of EPP in 2014. There is currently no alternative effective treatment for EPP patients.

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Publication:M2 EquityBites (EQB)
Date:Apr 12, 2017
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