Clinuvel’s management address patients’, shareholders’ questions
The EMA review is estimated to be completed between July and October 2014, yet further reviews by the Agency are possible.
The dossier we have filed is complex. Firstly, no other melanocortin has ever been submitted to European regulatory bodies.
The decision is taken by the entire Committee for Human Medicinal Products (CHMP) which represents all members of the European Community. The Clinuvel team is optimistic that it will receive a positive response from the EMA which will enable us to provide access to the drug for European EPP patients.
Naturally, there is a ‘plan B’. On the basis of the safety data generated over the past 20 years, there should not be any safety concerns. This is the first part of EMA’s equation of a risk-benefit analysis. The efficacy of SCENESSE® is subject to patients’ and physicians’ experiences; in this case the statistics are of supporting evidence. Clinical relevance of treatment can only be expressed and confirmed by patient groups and all global experts knowledgeable in the disease.
The drug is being priced in Italy and Switzerland and, depending on a number of parameters, the final price will be determined and revealed in due course. An important factor is the manufacturing and scalability of the product. However, in EPP Clinuvel will distribute to a relatively small number of patients.
Clinuvel’s teams have been in regular contact with the FDA during the program, as should be expected from a pharmaceutical company. It is increasingly apparent that EMA and FDA exchange information and thoughts. In this light an EMA approval will trigger Clinuvel’s New Drug Application in the US.
If a Fast Track Status is granted by the FDA for SCENESSE® treatment in EPP, the review process can be relatively swift.
The drug has been available through special access schemes for EPP patients in Italy and Switzerland since 2010. Our clinical experiences are excellent, and the distribution of the drug is very much driven by the academic demand, which in turn is driven by patients’ choice to opt in for the treatment.
The ultimate objective of this management was to develop a treatment for children with EPP. The ordeal that parents and children go through in porphyria is unspeakable and really, at times, unimaginable. Clinuvel’s scientists and management had initially underestimated the burden of EPP on juvenile patients and their families, until we actually met with them and discussed their experiences.
Vitiligo is in Phase II trials in Asia. An EPP approval will have a spill-over effect on the ability to progress SCENESSE® for vitiligo patients. A regulatory outcome will influence Clinuvel’s choices in vitiligo.
Europe: Clinuvel AG, T: +41 41 767 45 45
SCENESSE® is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of α-MSH, afamelanotide is a linear peptide which activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties (offering skin protection against light and UV radiation). SCENESSE® is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. For more information on SCENESSE® go to http://www.clinuvel.com/scenesse.
Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore.
- actual results may and often will differ materially from these forward-looking statements;
- no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved;
- no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place
- "Remember....Research is the key to your cure!"