INTERVIEW: Clinuvel's Philippe Wolgen on Scenesse and the patient factor
This article was originally published in Scrip
Not many pharmaceutical executives would take credit for helping to steer the European Medicines Agency in a particular direction when it comes to assessing new innovative medicines. But that's what Philippe Wolgen, CEO of the Australian rare diseases company Clinuvel, claims to have achieved when he decided to seek EU approval for the ground-breaking phototoxicity drug Scenesse with the close involvement of patients and physicians.
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“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.
Clinuvel is beginning the commercial launch in Europe of its orphan drug Scenesse for patients with erythropoietic protoporphyria, a rare condition that causes severe anaphylactic reactions and burns when the skin is exposed to sunlight.
The MHRA is losing no time in getting its much heralded “new era” of medicines regulation up and running.