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Clinuvel's company releases, including archives.

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

21 May 2012
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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. …

Appendix 4C - quarterly

29 Apr 2012
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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…

Swiss insurers agree to reimburse Clinuvel’s SCENESSE® for rare disease

25 Apr 2012
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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…

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

Clinuvel Corporate Update Presentation

21 Mar 2012
Entering commercialisation. March 2012 Corporate Update.

Appendix 3B

16 Mar 2012
Appendix 3B - New issue announcement, application for quotation of additional securities and agreement

Clinuvel, FDA agree in principle to Phase III study with SCENESSE® (afamelanotide)

15 Mar 2012
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SCENESSE® (afamelanotide 16mg) to be trialled for rare disease in US Phase III Melbourne, Australia and Baar, Switzerland, March 15 2012 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had reached an in principle agreement with the US Food and Drug Administration (FDA) to conduct a Phase III study of the novel drug SCENESSE® (afamelanotide 16mg implant) in the rare disease erythropoietic protoporphyria (EPP). Clinuvel is currently working to finalise the Phase III study (CUV039) protocol with the FDA following an End-of-Phase-II meeting held on Monday March 12. Study Design After the completion of pivotal EPP…

Observations from Clinuvel’s vitiligo and EPP programs being presented at the American Academy of Dermatology

15 Mar 2012
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SCENESSE® (afamelanotide 16mg implant) data and clinical reports to be discussed with global dermatology audience Melbourne, Australia and Baar, Switzerland, March 15 2012 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that data and observations from the Company’s lead clinical trial programs for its novel drug SCENESSE® (afamelanotide 16mg implant) will be presented at a series of meetings centred on the American Academy of Dermatology (AAD) meeting in San Diego held from March 15-20. Vitiligo: early US data, further encouraging observationsRepigmentation data and further clinical observations from Clinuvel’s open label Phase II US pilot trial of SCENESSE®…

Clinuvel Newsletter February 2012

29 Feb 2012
February 2012 Clinuvel Newsletter CEO's outlook | Clinuvel files MAA for SCENESSE® | INSPIRE vitiligo program update | Media coverage | CEO interview online | Share price & financials

Appendix 4D - Half Yearly Report

24 Feb 2012
Report for the half year ended 31 December 2011.
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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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