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Clinuvel Pharmaceuticals Ltd (ASX: CUV) has reached an agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the pricing of Clinuvel's drug Scenesse (afamelanotide 16mg) for the treatment of erythropoietic protoporphyria (EPP) patients, the company disclosed on Wednesday.
A randomized study conducted at two academic medical centers found that the combination of afamelanotide implant and narrow-band UVB phototherapy resulted in superior and faster repigmentation, compared with narrow-band UVB alone (JAMA Dermatol.
Current research is on Afamelanotide which is in phase II and III clinical trials and promising Melanocyte transplantation.
* Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.
GOTHENBURG, SWEDEN -- A resorbable subcutaneous implant of afamelanotide significantly reduced painful phototoxic attacks in patients with erythropoietic protoporphyria in a year-long multinational clinical trial.
The 12 month European and Australian study of SCENESSE (R) (generic name afamelanotide) is the first large scale study of a preventative drug for patients with EPP, dubbed an 'orphan' disease due to its rarity and severity.
Known as Afamelanotide, it prevents the disease in fair-skinned people and lasts for two months, and avoids recurrence.
Following my article "Why bronzing jabs give me the needle" of February 6, 2009, which stated that Melanotan (an injectable unregulated drug which is bought over the internet by people hoping to improve their tan) contains afamelanotide, I have been asked by the Australian company Clinuvel, which develops afamelanotide, to make clear that afamelanotide is a drug being clinically tested on patients suffering from various skin disorders including cancer and is unrelated to the illegal and untested chemical substances offered by online vendors under the unofficial name "Melanotan I and II".
Afamelanotide reduces the number and severity of phototoxic reactions, shortens recovery time, and markedly improves disease-related quality of life in adults who have erythropoietic protoporphyria, according to a report in the New England Journal of Medicine.
The European Medicines Agency has approved Australia-based Clinuvel Pharmaceuticals' Scenesse (afamelanotide 16mg) drug to treat adult patients with rare skin disorder, erythropoietic protoporphyria, it was reported yesterday.
SCENESSE (R) controls the release of its active ingredient, afamelanotide (16mg), in picogram concentration, one trillionth of a gram.
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