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Announcements

Clinuvel's company releases, including archives.

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Analyst Reports

External analyst coverage of Clinuvel, including full reports as PDF.

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Annual Reports

Clinuvel's Annual Reports to Shareholders.

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Newsletter

Clinuvel's regular newsletter, Clinuvel Communiqué, including archives.

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Press Coverage

International media coverage, including links to key articles.

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Clinuvel commences US Phase III trial of SCENESSE® in rare light and UV disorder

21 May 2012
US registration study in erythropoietic protoporphyria (EPP) underway Melbourne, Australia and Baar, Switzerland, May 22 2012 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has commenced its confirmatory Phase III US study of the novel drug SCENESSE® (afamelanotide) in patients diagnosed with the rare light intolerance disorder erythropoietic protoporphyria (EPP). The six-month, randomised, multicentre, double-blind, placebo-controlled study (CUV039) will recruit up to 100 adult EPP patients in seven specialist centres (Alabama, California, Michigan, New York, North Carolina, Texas and Utah). The US Food and Drug Administration (FDA) allowed the trial to proceed earlier this month. …
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Appendix 4C - quarterly

29 Apr 2012
Rule 4.7B Quarterly report for entities admitted on the basis of commitments Introduced 31/3/2000. Amended 30/9/2001, 24/10/2005. Name of entity CLINUVEL PHARMACEUTICALS LIMITED   ABN Quarter ended (“current quarter”) 88 089 644 119 31 MAR 2012 Consolidated statement of cash flows   Cash flows related to operating activities   Current quarter$A’000 Year to date (6 months) $A’000 1.1 Receipts from customers 40 865 1.2 Payments for        (a)   staff costs (b) advertising and marketing (c) research and development (d) leased assets (e) other working capital   (1,075) (53) (1,062) (61) (327)   (4,017) (167) (4,019) (165) (1,229) 1.3 Dividends received…
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Nomura Quick Note: "Afamelanotide receives approval in Switzerland"

26 Apr 2012
CUV announced that their afamelanotide product has been accepted by two health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light.
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Swiss insurers agree to reimburse Clinuvel’s SCENESSE® for rare disease

25 Apr 2012
Swiss regulator allows supply for EPP patients before formal approval Melbourne, Australia and Baar, Switzerland, April 26 2012 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that SCENESSE® (afamelanotide 16mg implant) has been accepted by two leading health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light. SCENESSE® can be supplied with immediate effect to physicians who treat approximately 50 EPP patients in Switzerland. The costs of supply will be covered in full by the insurance companies. This is…
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Nomura Update "Considerable upside should NSV trials be successful"

27 Mar 2012
NSV is a de-pigmenting disease that affects c10mn persons in the US and EU. CUV’s afamelanotide is being evaluated as a combination therapy with narrowband UVB light therapy in two clinical studies in patients with NSV. In early Phase II trial results presented at a recent conference, the NB-UVB plus afamelanotide group showed earlier onset of repigmentation compared to controls.
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Clinuvel Newsletter - April 2012

03 Apr 2012
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Clinuvel Newsletter - February 2012

29 Feb 2012
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Clinuvel Newsletter April 2012

02 Apr 2012
April 2012 US Bulletin CEO overview: US program update | US Phase III erythropoietic protoporphyria (EPP) protocol | FDA releases EPP patient interview footage | Vitiligo program presentation awarded
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Clinuvel Corporate Update Presentation

21 Mar 2012
Entering commercialisation. March 2012 Corporate Update.
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Nomura Quick Note: "Vitiligo and EPP opportunities progress"

16 Mar 2012
CUV has released: 1) clinically impressive interim Phase II Vitiligo trial results; and 2) US FDA agreement to be allowed to conduct a Phase III study in erythropoietic protoporphyria (EPP).
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Investors' Blog Posts

Delivering a therapy for those who need it most: EPP...

Earlier today we announced that two health insurers in Switzerland had agreed to reimburse SCENESSE® (afamelanotide) for the rare disease...

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MAA: a moment in Clinuvel’s EPP story...

Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first...

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Online evolution...

Earlier this week we unveiled a major update to our online presence with the release of our new-look website and the launch of Mothers...

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Investor Spotlight

Annual Report for the year ended 30 June 2011

Contents: INTRODUCTION ERYTHROPOIETIC PROTOPORPHYRIA (EPP) NONSEGMENTAL VITILIGO (NSV) CLINUVEL BUSINESS MODEL CORPORATE MILESTONES CHAIR's LETTER MANAGING DIRECTOR’S REPORT FINANCIALS ADDITIONAL INFORMATION REQUIRED BY THE ASX MARKET PERFORMANCE GLOSSARY ...

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Related Webcasts

Understanding Vitiligo: Misconception & Myth...

Vitiligo is a skin disorder which causes the loss of pigment - melanin - in the skin. Though it affects around 45 million people worldwide,...

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'Check up' reports on rare disease EPP and SCENESSE...

On 31 January 2012 Swiss TV channel Telezueri aired a report on erythropoietic protoporphyria (EPP), a rare genetic disorder which causes ab...

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"Focus really pays off in the end"...

Following Clinuvel's landmark filing of a marketing authorisation application for the drug SCENESSE® (afamelanotide) with the European Medic...

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