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CLINUVEL's company releases, including archives.

US Office for Orphan Products Development (OOPD) issues designation for the use of afamelanotide in the management of sun-induced solar urticaria. Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its photoprotective drug afamelanotide has been granted an orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the management of solar urticaria (SU). This is the second ODD granted to afamelanotide by the FDA since its awarded afamelanotide its ODD status for the treatment of erythropoietic porphyrias, a genetic haematological disorder. The FDA’s orphan drug designation is reserved for new drugs or therapies…
Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained preliminary results in its multicenter randomised double-blind placebo controlled PLE study (CUV015) evaluating the safety and efficacy of afamelanotide 20 mg implants. PLE is a recurrent seasonal UV-related skin disorder seen mostly in fair-skinned patients (10-20% incidence) in the northern hemisphere. Preliminary evaluation of 36 patients with recurrent PLE revealed a trend toward reduction of characteristic dermal symptoms. Analysis of the physician’s Global Severity Index during the 120 days and 150…
Significant pain reduction is demonstrated in light-intolerant patients with erythropoietic protoporphyria (EPP) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained promising 4-months results in testing afamelanotide in a multicentre randomised double-blind placebo controlled Phase III study in EPP (CUV017). In 2008, afamelanotide was awarded orphan drug designation (ODD) in the treatment of EPP by the FDA and EMEA. EPP patients are known to be absolutely intolerant to visible and UV light. This genetic disorder leads to an accumulation of protoporphyrin IX in the skin and an increased risk of incapacitating phototoxic reactions manifesting…
Thursday, 14 January 2010 11:00

Lapse of Unlisted Share Options

Lapse of Unlisted Share Options
Thursday, 14 January 2010 11:00

Appendix 3B

Appendix 3B
Friday, 29 January 2010 11:00

Appendix 4C

Appendix 4C
Friday, 05 February 2010 11:00

Appendix 4D - Half Yearly Report

Appendix 4D - Half Yearly Report
Erythropoietic protoporphyria (EPP) is the lead indication for afamelanotide’s final registration dossier Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has received positive scientific advice from the European Medicines Agency (EMA) - as part of its continuing dialogue with regulatory agencies - relevant to its application for Marketing Authorisation (MAA) for EPP this year. Following this advice Clinuvel will focus resources on the final development of afamelanotide for EPP, actinic keratosis (AK, precursor to skin cancer) and polymorphic light eruption (PLE). EMA’s Committee for Human Medicinal Products (CHMP) considered Clinuvel’s existing preclinical package, accompanied by ongoing studies, adequate to…
A global academic and clinical forum to capture the growing interest in UV radiation and skin damage Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had hosted its second Annual Scientific & Clinical Excellence Meeting (ASCEM II) in Switzerland. In light of the progress made in afamelanotide’s clinical development, more scientific interest is being shown from the medical community worldwide. Clinuvel’s objective for this meeting was to integrate basic molecular science, clinical care and medicinal photoprotection. The ASCEM was held on 21-22 February and was led by seven of the world’s foremost experts on molecular…
Phase II trial of novel drug in erythropoietic protoporphyria (EPP) to commence immediately Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the US Food and Drug Administration (FDA) has agreed for Clinuvel to proceed under its current Investigational New Drug (IND) to conduct a Phase II clinical trial (CUV030) to evaluate afamelanotide as a first-in-class photoprotective drug in patients diagnosed with erythropoietic protoporphyria (EPP). This outcome is a breakthrough in Clinuvel’s global clinical program and will be the first therapeutic clinical trial of afamelanotide in the US. Afamelanotide was granted orphan drug designations (ODD) for EPP…

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