FDA Clarifies SCENESSE® PDUFA Date

Company Announcement A SX: CUV Nasdaq International Designation: CLVLY XETRA-DAX: UR9 FDA CLARIFIES SCENESSE® PDUFA DATE PDUFA goal date confirmed for 8 October 2019 ____________________________________________________________________________________________________________________________________ Me lbourne, Australia, 02 October 2019 CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) has notified the company that the Prescription Drug User Fee Act (PDUFA) goal date for review of the submission of the SCENESSE® (afamelanotide 16mg) scientific dossier had been miscommunicated by the Agency and now has been confirmed for 8 October 2019, instead of the earlier reported 6 October. 1 “ Our team continues to engage with the FDA at this late stage to address final questions and clarifications on the dossier,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “While it may be frustrating for all who take an active interest in our programs , nothing materially has changed in our outlook and we will continue our diligent approach in the coming days to seek a positive outcome.” - En d - 1 SCENESSE® (afamelanotide16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA- DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information please go to http://www.clinuvel.com. SC ENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD. H ead of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD In vestor enquiries https://www.clinuvel.com/investors/contact-us F orward-Looking Statements This release contains forward -looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward- looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE ® (afamelanotide 16mg); our ability to achieve expected safety and efficacy results through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and r egulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 201 9 Preliminary Financial Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update o r revise any forward- looking statement, whether as a result of new information, future events or otherwise. More information on the forecasts and estimates is available on request. Past performance is not an indicator of future performance. www.clinuvel.com Level 11 T +61 3 9660 4900 535 Bourke Street F +61 3 9660 4999 Melbourne Victoria, Australia, 3000

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