As many of you may know, this week saw Clinuvel hold its Annual General Meeting in the Melbourne Town Hall. As managing director I welcome these opportunities where I am able to meet and talk to the people whom Clinuvel considers integral to the company and its existence; the Board of Directors sees Clinuvel’s investors as unique. In Clinuvel, an investor has to fundamentally believe in the premise of offering pharmaceutical photoprotection, a novel option, an innovative approach to skin disorders.
In a meeting that would be considered short by international standards I was both excited and proud to present some of the achievements and milestones our team has reached this year, and lay out our plans for the next 12 months.
This blog is not a perfect forum for delivering insight and news with the same level of detail and clarity as can be achieved in person, but I wish to readdress some key points from the AGM.
Through its 19-year development we realise afamelanotide as a 1st in class drug, it’s the world’s first medicinal photoprotectant. It has inherent ‘novelty’ on five significant fronts;
- afamelanotide is a new chemical entity (NCE), implying that the molecule is a first therapeutic;
- Clinuvel presents the concept and reality of medicinal photoprotection, an entirely new field of study of the effects of light on skin, albeit with a direct need and growing importance;
- a controlled release mechanism developed to maximise safety and efficacy presents a pure innovative technology;
- afamelanotide offers a prophylactic therapeutic treatment in rare (orphan) diseases, EPP and SU;
- seasonality of the disease symptoms (photodermatoses).
Above all else is the fact that Clinuvel is working to introduce a new pharmaceutical treatment option where there is both great clinical need and no viable or effective alternative at present.
A further highlight for me was the opportunity to present and dissect the sheer scale of effort and complexity present for the duration of our clinical and regulatory program. In the last phase of commercialisation, our communications teams, represented across three continents are important to distribute and control the messages around our internal development.
Clinuvel – alike many drug developers – has been involved in an extended period of ‘R & D’, but for the last four years we have been focused on the ‘D’, which as we enter our final stages, is of profound value and importance.
I was delighted to receive financially relevant and scientific questions shortly before the meeting, giving me time to prepare a detailed response. While the technical and scientific detail of the answers given often veered into territory that requires deep medical knowledge and understanding, it was an encouraging development and interesting discussion.
It also gave me the opportunity to dispel incorrect understandings that we find often with specialists in relation to α-MSH. An instance, is the origin of the hormone, the common assumption is that it is created by the pituitary gland. Research has confirmed that α-MSH is predominantly synthesised in epidermal cells, the keratinocytes of the top layer of the skin. This is an important distainction, and afamelanotide acting as a paracrine hormone offers additional data in terms of safety long-term.
I believe the scientific, medical and commercial entities are starting to show a keen interest in α-MSH, it is almost as if the world is slowly realising the potential of this molecule. An opinion supported by the popularity of afamelanotide and Clinuvel at the EADV in Berlin recently, where afamelanotide was the subject of many different sessions.
There was much interest in the value at Clinuvel’s AGM, main questions were on the timelines and regulatory route to market. I hope that the global audience is starting to realise that the uniqueness and novelty of Clinuvel’s afamelanotide is not to be compared to any other drug in development. The focus on this development of the past 19 years, – and 4 years under my management – , is slowly paying off as more and more physicians are requesting to work with our drug. Better proof than clinical demand does not exist, doing good for patients is the main driver during the development process. Only when safety and clinical evidence of efficacy hold up, do I dare speak about financial returns.
During the next 12 months, the company will do everything possible to file for EPP, while other indications will be in Phase III. Not many peer companies have such an extensive program on one drug. In the coming weeks I will aim to elaborate more fully on some of the concepts and ideas I presented as they hold value and interest for more than just those who were present.
In the meantime, on behalf of our team I thank all for the patience and belief in the company, keep in mind: no other group or company in the world has succeeded in bringing this molecule to commercial phase, the complexity is a barrier to entry, after all an additional asset to our product.