Clinuvel receive an appropriate price for an orphan drug...

Clinuvel receive an appropriate price for an orphan drug treating EPP in Europe with payment for the drug, Scenesse, by health insurers or Govt health authorities. 5 countries on board to date with negotiations taking place with others but further on-boarding slow with resistance to price in the UK and Norway identified as health is Govt funded in these jurisdictions. EMA approval is for up to 4 implants per annum with left open for additional implants where warranted in opinion of patients doctors. Implant price is fixed at E14,100.95 (Euro), which approximates A$22,500. x3-4 is A$67,500 to $90,000 per annum per patient. A limiting factor in treating countries, particularly Germany, has been the number of treatment centres and places available. Information is that Germany (the country with largest patient numbers) is expanding these. Also, treatment is seasonal which affects cash flows. There is no other treatment for EPP. Plus it works. Clinuvel has also indicated Scenesse could potentially other orphan porphyrias, XP and VP. It is quite possible that the drug could have exciting other applications that the company will not expand on until after FDA give approval for treatment of EPP in the US. Clinuvel also have topical applications of afamelanotide in development that are very close to being released. There has been a lot of news over the last 12 months with the company pushing out information, which could lead to a flood of news after FDA approval scheduled with an 8 July 2019 PDUFA date.