Pharmaceutical
Division

A Sixth Indication

CLINUVEL’s research and development evolves and adapts to the data generated from the use of afamelanotide and global understanding of the potential of our technology to assist patients and broader audiences, as well as the willingness of decision makers to accept the introduction of a novel technology.

Similar to many innovative technologies, the relevant environment must be prepared to accept new concepts and disruptive chemical entities and therapies. For CLINUVEL this means ensuring acknowledgement and acceptance by thought leading clinicians and academics, but also by patients and regulatory authorities prior to the start of a novel clinical program.

The selection of a CLINUVEL-sponsored indication usually takes two to three years from identification to confirmation and acknowledgement by clinical and academic leaders in the field. The CLINUVEL team generally works with selected experts in clinical medicine and research when launching a new program. Occasionally, programs are sponsored by hospitals or individual physicians to initiate treatment, but these pilot studies are not financially supported by CLINUVEL, and data are generally not used for regulatory filings.

In the case of the sixth indication, CLINUVEL has worked with leading academics to develop and sponsor a program whereby CLINUVEL identified that there is an/a:

I.identified high clinical need for treatment

II. lack of alternative or effective treatments available or in development

III.acknowledgment of the proposed treatment by the majority of selected research and clinical experts internationally

IV.consensus on the safety of afamelanotide use in the selected patient population

V.high cost to society from the diseased state of patients

VI.absence of current or foreseeable competition from other comparable treatments or melanocortins

VII.clear understanding whether substantial clinical value can be expected from the use of afamelanotide/melanocortins

VIII.portfolio of intellectual property, and

IX.high likelihood of regulatory authorisation for the proposed drug in the indication.

These nine selection criteria are usually the driving factors for CLINUVEL’s decisions to make afamelanotide or its portfolio of melanocortins available for further clinical use.

Unless there is an in-house consensus as well as agreement with respected leaders in clinical medicine and fundamental research, the decision to enter a field is not made. Only when ALL criteria are met, does CLINUVEL progress with the program.

Further work and efforts are underway to finalise a clinical program for a sixth clinical indication.

Having identified a potential “sixth” indication in 2014, the acute, debilitating, limiting and life-threatening nature of the indication required CLINUVEL to put in place a number of processes to assess the workability and viability of the clinical trial program.

Following the nine criteria described above, institutional agreements are currently being put in place. Intellectual property has been secured, and the clinical workability is being finalised with global experts in the medical fields.

Once all agreements with Ethics Committees, Institutional Review Boards and authorities are reached, CLINUVEL will be able to disclose its sixth indication. This will mark the finalisation of seven years of internal and external discussions, contemplation and assessment before the new exciting clinical phase can start.

In anticipation of US FDA’s authorisation of its first product (obtained in October 2019), the CLINUVEL team worked towards the expansion (technology translation) of its portfolio of melanocortins towards broader indications and populations. As part of CLINUVEL’s overall strategy, acute and life-threatening diseases could only be addressed once European and American marketing authorisations were to be received.

The current pipeline of indications, follow-on products and Targeted Technology Translation (TTT) reflects the execution of a long-standing strategy. The foundation of CLINUVEL’s plan lies in the consistent attention to afamelanotide’s clinical safety, and systems put in place to monitor patients over the long-term. Without this Company-wide emphasis on safety, no further expansion would have been possible.

Clinuvel
strategic update II
April 2021

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