The FDA has granted ‘breakthrough status’ this year on 15 potential drugs, mostly for cancer and rare diseases The US Food and Drug Administration already has numerous ways it can speed up the market authorisation of new medicines, ranging from 'accelerated approvals' to 'priority reviews' to its fast-track program. Even so, sometimes the existing mechanisms for speeding drugs to market, which typically require data from the traditional three phases of drug development, still take considerable amounts of time. The so-called 'breakthrough therapy' designation introduction may be a signal that the FDA will approve exceptional drugs more quickly with this new regulatory pathway. Ultimately, a breakthrough drug may be approved by the FDA without completing all three phases of clinical trials…

CUV has successfully raised AUD6.3mn via a private placement to international institutional and professional investors. The Placement was conducted at price of AUD2.136 per share, representing a 4.3% premium to the 20-day volume weighted average price on April 29 and 15.1% to the closing price on April 30.

CLINUVEL filed its MAA for afamelanotide 16mg implant on 6 February 2012 for the preventative treatment of the orphan light intolerance disorder erythropoietic protoporphyria (EPP).

1H13 - awaiting EMA registration decision Anchor themes We continue to believe that there is a very high possibility of CUV getting afamelanotide to the market. This points to cashflow from sales, and sooner than for most other biotechnology companies Download the PDF to access the full report.

CUV announced successful, statistically significant results from its US Phase IIa pilot study (CUV102) of its afamelanotide 16mg implant in the pigmentation disorder Vitiligo.

Preliminary observations from CUV’s open-label Phase IIa US pilot trial of its drug, afamelanotide, in four patients with Vitiligo (a de-pigmenting skin disease) have been published in the journal Archives of Dermatology. In total, 56 patients are participating in the trial, with results from the six-month treatment period expected to be released before the end of CY12.

Vitiligo market is underserved in our view - CUV’s potential product addresses this.

CUV raised AUD6.0mn via a placement at a price of AUD1.75 per share. Management state that the funds raised in the placement will be used for: 1) a US Phase III clinical trial in erythropoietic protoporphyria (EPP); 2) a global clinical trial program in patients with Vitiligo; and 3) working capital during the evaluation of the Marketing Authorisation Application (MAA) for afamelanotide for the prophylactic treatment of adult patients with EPP by the European Medicine Agency (EMA).

CLINUVEL Pharmaceuticals (CUV) has started its confirmatory Phase III US study of the novel drug afamelanotide, for the treatment of erythropoietic protoporphyria (EPP), a rare light intolerance disorder. The Phase III trial protocol has been designed in close consultation with the US Food and Drug Administration (FDA).