EB25 Apr 2016 10:59
Little known fact for those not familiar with the biotech regulatory world (inc Amryt it would seem), epidermolysis bullosa (EB) is a paediatric orphan indication. If a product is registered in the US for this class of indication the company becomes eligible for an FDA accelerated review voucher which can cut three to six months off the review process for market authorisation of the company's next drug. Great for the company as it can generate revenues quicker. However, these vouchers can be sold to big pharma allowing, for example, Novartis to bring a 1Bn per year blockbuster to the market 6 months earlier. I believe one voucher was sold recently to a big pharma for $100M. A big win-win. If Birken get on with it and complete the Phase III quickly and do an MAA in the EU and US quickly, Amryt could have this voucher in their hands within 18 months or so.