Thursday, May 9, 2013
SCENESSE® data to be presented at American Academy of Dermatology, San Gallicano Rare Disease conferences-US Info
SCENESSE® data to be presented at American Academy of Dermatology, San
Gallicano Rare Disease conferences
Vitiligo and erythropoietic protoporphyria (EPP) programs to feature at leading academic meetings
Melbourne, Australia and Baar, Switzerland, March 1, 2013
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) today announced that data from its
clinical studies of the novel drug SCENESSE® (afamelanotide 16mg implant) in vitiligo and erythropoietic
protoporphyria (EPP) will be presented at two international academic conferences this week.
Results and clinical observations from the Phase IIa study of SCENESSE® in vitiligo (CUV102) will be presented at
the Vitiligo Working Group meeting, accompanying the American Academy of Dermatology AAD meeting in Miami.
An abstract featuring the CUV102 study will also be presented to the AAD Residents and Fellows Symposium at the
main AAD meeting.
Experiences of the use of SCENESSE® as a photoprotective in the rare disease EPP in Italy will be discussed at the
San Gallicano Conference on Rare diseases. This presentation will focus on the experiences with the drug in both
clinical trials and commercial use in Italy.
– End –
American Academy of Dermatology, Miami
Isedeh P, Agbai O, Lim HW & Hamzavi I (2013). “A Proof of Concept Study to Compare the Efficacy of Subcutaneous
Afamelanotide Implants and Narrow‐Band Ultraviolet B (NB‐UVB) Phototherapy versus NB‐UVB Alone in the
Treatment of Nonsegmental Vitiligo.” Vitiligo Working Group Meeting, Miami, February 28.
Agbai O, Lim HW & Hamzavi I (2013). “A Proof of Concept Study to Compare the Efficacy and Safety of
Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow‐Band Ultraviolet B (NB‐UVB) Light versus
Narrow‐Band Ultraviolet B (NB‐UVB) Light Alone in the Treatment of Nonsegmental Vitiligo.” American Academy
of Dermatology Meeting Residents & Fellows Symposium, Miami, March 3.
Rare Disease Conference, Rome
Biolcati, G “Terapia EPP.” Le Malattie Rare All’Instituto San Gallicano, Rome, March 1.
About SCENESSE® (afamelanotide)
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
SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd.
About Clinuvel Pharmaceuticals Limited
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.
In February 2012 SCENESSE® was filed for review by the European Medicines Agency for EPP. A confirmatory six month
Phase III US EPP trial commenced in May 2012. Presently, there is no known effective treatment for EPP and SCENESSE® has
been granted orphan drug status. Based in Melbourne, Australia, Clinuvel has operations in Europe and the US.
For more information go to http://www.clinuvel.com.
Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900
Europe: Clinuvel AG, T: +41 41 767 45 45
T: +41 41 767 45 45
Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV‐related
skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant
risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document
that relate to prospective events or developments (forward‐looking statements), investors should note the following:
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
Level 14 / 190 Queen Street T +61 3 9660 4900 www.clinuvel.com
Melbourne, Victoria 3000 F +61 3 9660 4999
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