Clinuvel: Structural changes in preparation for commercial phase
Structural changes in preparation for commercial phase Rotation of Chairman and establishment of Commercial Management Committee
Melbourne, Australia - Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced changes to its management team which will optimise the commercialisation of SCENESSE (afamelanotide).
With effect from 1st July 2010 Mr Stan McLiesh - formerly General Manager, Pharmaceuticals at CSL - will assume the role of non-executive Chairman of Clinuvel. While at CSL, Mr McLiesh led the negotiations for various in-licensing agreements which expanded the company's international markets.
As the new Chairman and head of the newly formed Commercial Management Committee Mr McLiesh is expected to lead the evaluation of the opportunities available to distribute and effectively commercialise SCENESSE.
Mrs Brenda Shanahan, who has successfully guided the progress of the company over the past two years as Chair, will preside over the Audit and Risk Committee and generally hold a watching brief over the financial direction of Clinuvel. Under Mrs Shanahan's stewardship the company substantially expanded its clinical development activities and obtained its first IND from the FDA.
Clinuvel's CEO, Dr Philippe Wolgen, commented: "At this critical stage of development, it is essential that the company focus on the commercial challenges ahead. Therefore there is a clear rationale to establish a Commercial Management Committee. This group will assist in determining the best commercial options for our innovative drug.
"I would like to thank Mrs Shanahan for successfully steering the company for the past two years through difficult paths and for her continuing contribution to Clinuvel.
"As we enter an exciting phase, I wish Mr McLiesh much success in his new role with the company."
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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, SCENESSE is a linear peptide which activates the skin to activate eumelanin, the dark pigment which is known to have photoprotective properties (providing 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.
SCENESSE is a registered trademark of Clinuvel Pharmaceuticals Ltd.
About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection. Currently, Clinuvel is in its final stages to complete testing of SCENESSE in Phase II and III trials in Australia, Europe and the United States. Clinuvel's ongoing focus is to demonstrate the safety and efficacy of SCENESSE. Pending positive clinical results, Clinuvel aims to file SCENESSE for its first market approval for the orphan indication porphyria (EPP).
Clinuvel is currently testing SCENESSE in five clinical indications:
Clinical Trial Status
Erythropoietic Protoporphyria (EPP)
Absolute sun/UV intolerance
Phase III trial full results due
Confirmatory Phase III trial approved August 2009
Actinic Keratosis (AK) and Squamous Cell Carcinoma (SCC) in Organ Transplant Recipients (OTRs)
Skin cancer in transplant patients
Phase II trial started October 2007
Polymorphic Light Eruption (PLE / PMLE)
Severe sun/UV poisoning
Phase III trial preliminary results reported December 2009
Solar Urticaria (SU)
Acute anaphylactic reaction to sun/UV
Phase II trial results reported July 2009*
Photodynamic Therapy (PDT) - systemic
Phototoxicity following cancer treatment
Phase II trial results reported December 2009*
*Program deferred February 2010.
Phase I and II human clinical trials using SCENESSE have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.
Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE. For more information go to http://www.clinuvel.com.
For more information contact: Australia Europe Lachlan Hay Daniela Schaefer Head of Global Network and Communications Head of Business Operations Europe Clinuvel Pharmaceuticals Limited Clinuvel AG T: +61 3 9660 4900 T: +41 44 253 75 00 E: [email protected]@clinuvel.com>
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 11 / 330 Collins Street T +61 3 9660 4900 www.clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia