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Diligence And Janitors Needed To Keep Europe Innovating, Says Orphan Approval Pioneer

This article was originally published in Scrip

Executive Summary

The Australian company Clinuvel made a splash last year when it gained EU approval for its groundbreaking photoprotective therapy Scenesse (afamelanotide 16mg) – an orphan drug with a novel mode of action for a relatively unknown disease that was developed with the close involvement of patients who had received the treatment. As the European Medicines Agency prepares to consult on its new "PRIME" (priority medicines) scheme for giving more early support to drug developers, Clinuvel CEO Dr Philippe Wolgen explains what he thinks the agency really needs to do to foster true innovation in the EU.

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Interview: Clinuvel, A Company That Does The Unusual

“There will be one price and no discounts, no backroom deals, no incentives off the record.” In an interview with the Pink Sheet, Clinuvel UK’s general manager Lachlan Hay talked about the company’s unusual pricing policy for its equally unusual photoprotective therapy, Scenesse (afamelanotide), its frustrations at out-of-sync regulatory and market access systems, and how its plans for a US regulatory filing are going.


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