Corporate News & Publications

CLINUVEL's company releases, including archives.

Thursday, 30 July 2015 18:14

Form 605 - July 30 2015

Wednesday, 15 July 2015 17:12

Clinuvel Newsletter - July 2015

Breakthrough treatment for orphan genetic disorder presented to the general medical community EXECUTIVE SUMMARY SCENESSE® published as innovative treatment in erythropoietic protoporphyria (EPP) Combined analyses of Phase III studies show significant improvement in the duration of patient sun exposure without phototoxicity New England Journal of Medicine: highest “impact factor” medical journal Pivotal studies led to December 2014 European marketing authorisation Melbourne, Australia and Leatherhead, UK Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that results from its pivotal Phase III studies of SCENESSE® (afamelanotide 16mg) in the orphan genetic disorder erythropoietic protoporphyria (EPP) have been published in…
Friday, 05 June 2015 13:50

SCENESSE® Commercialisation Update

SUMMARY SCENESSE® Risk Management Plan infrastructure nearing finalisation EPP expert centre training commences this week Leatherhead, UK and Melbourne, Australia Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercial distribution of its drug SCENESSE® (afamelanotide 16mg) for erythropoietic protoporphyria (EPP) across Europe. SCENESSE® was granted marketing authorisation by the European Commission for adults diagnosed with EPP on December 22, 2014. A number of post-authorisation commitments were agreed with the European Medicines Agency (EMA) under a long-term risk management plan (RMP) for SCENESSE®. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is scheduled to complete…
Friday, 15 May 2015 14:00

Media Coverage

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To receive regular updates, including all of CLINUVEL's announcements, you can subscribe to our email database here. A selection of press coverage is listed below Title Link Aus dem Schatten hervortreten NZZ Exposure to sunlight burns my skin – now I can come out the shadows thanks to new drug Bournemouth Echo INTERVIEW: CLINUVEL's Philippe Wolgen on Scenesse and the patient factor Scrip CLINUVEL's subisidiary develops drug candidate for vitiligo Biospectrum Asia Wanneer de zon een hel wordt VTM News Out of the shadows (content only available in the USA) NBC Dateline 11-Year-Old 'Allergic' to Sunlight Good Morning America Implanted…
Singaporean subsidiary VALLAURIX completes preliminary evaluation of VLRX001 SUMMARY Clinuvel expands pipeline with VLRX001 targeting skin disorders First therapeutic target: vitiligo (depigmentation disorder) as maintenance therapy following SCENESSE® (afamelanotide 16mg) Innovation is the result of collaboration between Clinuvel and the international research community Proprietary technology of VALLAURIX PTE LTD, a majority-owned Clinuvel subsidiary Recent clinical research has demonstrated a renaissance in the demand for novel melanocortin molecules Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA: UR9; ADR: CLVLY) today announced that its Singaporean subsidiary VALLAURIX PTE LTD has successfully completed initial in-vitro development of VLRX001, an innovative melanocortin analogue. VLRX001 is an…
Monday, 27 April 2015 15:59

Appendix 4C - Q3 FY15

Tuesday, 31 March 2015 16:59

Clinuvel relocates Melbourne office

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its head office in Melbourne has relocated. The new address, which will also be the Company’s Registered Address, is: Level 5160 Queen StMelbourneVictoria, Australia 3000 All telephone and fax numbers remain the same. - End - About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with…
Friday, 20 March 2015 17:16

Appendix 3B - March 20

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has featured in an editorial in the peer-reviewed Journal of Investigative Dermatology. The editorial – “An α-MSH analogue in erythropoietic protoporphyria” – reviews both Clinuvel’s program and the broader history of the bench to bedside development of α-MSH as a therapeutic drug. In their concluding remarks, the authors note that “[t]he approval of afamelanotide by the European Medicines Agency in late 2014 can be regarded as a breakthrough for α-MSH in clinical medicine.” SCENESSE® was approved under exceptional circumstances by the European Medicines…

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