Clinuvel Company News

Clinuvel today released positive results from our first Phase IIa study of SCENESSE® (afamelanotide) in the common pigmentary disorder vitiligo. For full details of this study, read our announcement: SCENESSE® successful in Phase IIa vitiligo study. We've also released a Q&A document on the study, a copy of which can be found on the blog.

Clinuvel 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). Read the company's full announcement. Media coverage: Australian Life Scientist, BioSpectrum Analyst coverage from Nomura is available on our investor site.

Clinuvel has filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for the orphan disease erythropoietic protoporphyria (EPP). To read the company's full announcement, click here. Read a blog post from Clinuvel's CEO, Dr Philippe Wolgen, on the MAA filing: MAA: a moment in Clinuvel's EPP story Media coverage: Australian Life Scientist, Online Pharma Times Analyst coverage from Nomura is available on our investor site. To learn more about our EPP program, click here.

Clinuvel has released results from its Phase III study of SCENESSE® (afamelanotide) in the orphan designated disease erythropoietic protoporphyria (EPP).This study (CUV029) was conducted in eight centres across Europe. To read the results, click here. Media coverage: Reuters, Australian Life Scientist, The Age Analyst coverage from Nomura and Edison research is available on our investor site.

Clinuvel has been the focus of articles in the Financial Times and Reuters in recent weeks. To read more, click the links below DateTitleLink 22/12/2011 Clinuvel Scenesse yields positive data in EPP Link 21/12/2011 Clinuvel Filing for Scenesse In EU on Phase III Data in EPP Link 21/12/2011 Drug helps the sun to shine for those with an allergy to light Link 19/12/2011 Clinuvel drug seen safe, effective in pivotal trial Link 15/12/2011 Bringing the Online Investor Centre to Life Link 09/12/2011 When a tan is good for your health Link 02/12/2011 INTERVIEW-Tiny Clinuvel spurns tanning for medical need Link 08/11/2011 Clinuvel Pharmaceuticals secures patent for melanin activating drugs Link 03/11/2011 Clinuvel Analyses From U.S. Study Show ‘Dramatic Improvement’ Link 21/10/2011 Clinuvel Pharmaceuticals’ U.S. trial shows positive results of accelerated repigmentation in people Link 21/10/2011 Clinuvel Pharmaceuticals Announces First Positive Observations from Vitiligo Trial Link

In November Clinuvel released results from our first Phase II study of SCENESSE (afamelanotide) conducted in the USA. You can read the company's full release here along with comments from CEO, Dr Philippe Wolgen, on the blog. Press coverage: Australian Life Scientist | Biospectrum Asia | Pharmaceutical Business Review

Clinuvel hosted the company's 2011 Annual General Meeting (AGM) on Wednesday November 9 in Melbourne, Australia. View the CEO's AGM presentation (pdf) View the Results of Meeting ASX announcement (pdf) View the Notice of Meeting ASX announcement (pdf)

Since commencing a special access 648/96 scheme 11 months ago Clinuvel's SCENESSE® (afamelanotide) has been distributed to approximately 40 patients in Italy to treat EPP, a severe genetic disorder designated as ‘orphan’ disease. During this period the company recorded approximately A$1 million worth of sales. Clinuvel is reimbursed for the drug by the Italian health system. Read the company's full announcement (pdf). Press coverage: Business Spectator