Clinuvel Pharmaceuticals Limited announced that it has entered a second agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the ongoing treatment and reimbursement of SCENESSE® (afamelanotide 16mg) in adult erythropoietic protoporphyria (EPP) patients. SCENESSE® is the only approved treatment for adult EPP patients in Europe. As CLINUVEL sought to obtain reimbursement for SCENESSE® in Germany in 2016, an escalation to the German Court of Arbitration was required in 2017 for a legal opinion to be issued confirming the benefits of the first-in- class treatment and its fair clinical value.

Due to a fixed review period imposed in 2016 by the German Federal Joint Committee (G-BA), renewed negotiations were mandated between G-BA, GKV-SV and the Company. During the past 19 months the SCENESSE® treatment was once again reviewed, and the GKV-SV acknowledged its full benefit demonstrated during clinical trials and real-world conditions, as well as its value. The terms and conditions, as well as the duration of the commercial agreement are kept confidential under statutory obligations.

EPP TREATMENT CONTINUATION IN GERMANY: Approximately 90% of the German population benefits from healthcare coverage through statutory health insurers, represented by GKV-SV. The remaining 10% of the German population is either covered by private insurance (PKV) or enjoys complementary insurance. Pharmaceutical companies seeking market access in Germany are subjected to various assessments through a number of authorities (IQWiG1, G-BA and GKV-SV), obligating multiple rounds of negotiation about clinical benefits, economic value, national budget impact, and pricing of the proposed medicinal therapy.

Agreements with GKV-SV are the final step to enabling or continuing market access for approved therapies in Germany.