Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first official filing for SCENESSE® (afamelanotide) with the European Medicines Agency. It has taken our teams around six years to arrive at this point. Benchmarked against peer companies, it is a relatively swift development path for a first-in-class drug; we first publicly announced our erythropoietic protoporphyria (EPP) program in September 2006. It is an opportune moment to reflect briefly on how we reached this milestone and then discuss the steps that must be taken from here. (more…)
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Drug development is time consuming, expensive and fraught with risk. Setting aside commercial considerations, the scientific rational for the use of a drug and its introduction into the clinic requires a deep level of scientific and medical understanding in an environment which is continuously changing. The less common the drug class or clinical indication, the less likely one is to find individual experts who have the capacity to properly evaluate whether a drug is safe and effective for use in a clinical setting. Here one needs to learn while progressing, learning on the job due to lack of precedent.
