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Appendix 4E – Preliminary Final Report 2016/17

30 August 2017

CLINUVEL PHARMACEUTICALS LTD 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 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. Based in Melbourne, Australia, CLINUVEL has operations in Europe, the USA and Singapore, with the UK acting as the EU Distribution Centre. There were a number of significant events in 2016/17. These events included:

  • On 6 July 2016, the Company announced the US Food and Drug Administration (FDA) had granted SCENESSE® a Fast Track designation for the treatment of EPP.
  • It was announced on 18 July 2016 that the FDA had concluded an initial review of CLINUVEL’s clinical data package for its drug SCENESSE® in patients with EPP and deemed CLINUVEL’s clinical data package satisfactory for submitting a NDA application.
  • On 3 August 2016, the Company announced that it has fulfilled the FDA requirement to demonstrate safety in a pre-clinical model prior to progressing further with the clinical development of the combination therapy of its drug SCENESSE® and narrowband UVB (NB-UVB) light in the pigmentation disorder vitiligo.
  • On 9 November 2016, the Company announced it had met with the FDA’s Division of Dermatology and Dental Products (DDDP) to discuss the content and format of a NDA submission as part of the US regulatory pathway for SCENESSE®.
  • An announcement on 18 October 2016 that England’s National Institute for Health and Care Excellence (NICE) had made a recommendation to the UK Department of Health for SCENESSE® to be evaluated under the mainstream Single Technology Appraisal (STA) procedure.
  • An announcement on 12 April 2017 that the Company had reached agreement with the German National Association of Statutory Health Insurance Funds (GKVSV) for the treatment of EPP patients with SCENESSE®.

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