Clinuvel Pharmaceuticals Limited : Letter from the...

Clinuvel Pharmaceuticals Limited : Letter from the CEO
01/07/2013| 07:03am US/Eastern
Dear Shareholders,

Clinuvel is entering 2013 with much optimism and we eagerly await the final EMA review of SCENESSE® as a photoprotective for erythropoietic protoporphyria patients. I take this opportunity to provide an overview of progress and wish you all a successful year ahead.

Retrospect
The year 2012 ended on a high note with excellent and unexpected vitiligo Phase II results (CUV102), and we are currently deliberating the best course for the vitiligo program. Many factors come into play in taking these decisions: the cost of the clinical program, choice of markets, regulatory issues, pricing and demographics to mention a few. Potentially, our lead drug seems to be a major advancement in the treatment of this disease and our choice for this indication seems justified at first sight. In due course, the Clinuvel Board will unfold its plans for the vitiligo program.

The most significant operational event has been marked by the passing of Dr Hank Agersborg in September. Hank has given Clinuvel a unique approach to drug development, his experience has been of much value.

Outlook
Dr Dennis Wright has picked up the baton and now leads the scientific program of the company. Surrounded with international scientific staff, Dr Wright is poised to achieve the company's objectives of further research and development as well in commercialisation of SCENESSE®. As iterated previously, the success of Clinuvel largely hinges on the ability to retain key staff within the company. Therefore, I am pleased that we have been able to maintain the same organisational structure throughout the development of the drug. With much pleasure, we have added senior staff and we will keep looking out for talent.

As the US Phase III study in EPP (CUV039) draws to a close, our team has started data collection and preparation of the close-out of various trial centres. Data management in 2013 will provide us with the analyses to evaluate the safety and efficacy of SCENESSE® in US patients. There is much excitement within Clinuvel to learn these results, and pending the outcome a dialogue will be held with the FDA to assess the chance of regulatory approval for this patient population.

In summary, the development of a new chemical entity (NCE) in Europe and the US is a unique event, as it is relatively rare in one's lifetime to be able to develop a new class of drug and novel formulation for patient populations who do not receive adequate medical treatment. The innovation and complexity of Clinuvel's development program has excited our Board and staff for the past eight years now, and in 2013 we all will learn the regulators' willingness to award patients a treatment which seems to affect their lives in a substantial manner.

As the EMA is conducting final audits of our major suppliers, manufacturers and ancillary services, and is obtaining clinical information from the experts and patients affected, the process of gathering evidence will need to lead to a balanced regulatory outcome. In the EMA's assessment, risk versus benefit of allowing the drug for the EPP patients will be made. Various other factors will also play a role in the final verdict, and I am positive that Clinuvel's course of development has optimised the chances of obtaining marketing authorisation for SCENESSE®. Based on the drug's safety, patients' clinical needs and physicians' feedback, Clinuvel should be standing a more than fair chance of approval.

I wish you all a year of well-being and good health.

Philippe Wolgen

Chief Executive Office,
Clinuvel Pharmaceuticals Ltd