CUV 3.67% $24.14 clinuvel pharmaceuticals limited

3 update of data and comment 3

  1. 22,691 Posts.
    Study: Post 1.

    Web site: http://www.epitan.com.au/

    Finance. 25 Aug. 2003: After the placement EPT has over $10 cash and 111.5 mill. shares.

    Wayne Millen, the MD of EPT that is developing Melanotan, said it should be available by 2005.
    "You will go on your holiday with your tan already in place so that you reduce the **risk** of skin cancer."

    Melanotan works by boosting melanin, the skin pigment that makes us brown and protects us against skin cancer".

    After the placement on 25 August, EPT said: In addition, the company can now expand its clinical trial strategy to include therapeutic indications such as polymorphous light eruption ("PMLE") which is a significant UV induced skin allergy in northern latitudes.

    It is estimated that between 10-20% of the population of North America, Britain and Scandinavia suffer from PMLE in spring and early summer. We are becoming increasingly confident from our studies that Melanotan can be used to address these sun induced skin disorders."
    _______________________________________

    There are a number of ways this drug can be applied:

    Collaboration Agreement to develop topical formulation of the drug-Date 20/5/03:
    http://www.epitan.com.au/news_announcements.aspx?view=18

    EpiTan expands group collaboration on topical formulation of Melanotan®-Date 3/6/2003:
    http://www.epitan.com.au/news_announcements.aspx?view=19

    EpiTan Develops Sustained Release Formulation for Melanotan-Date 10/2/03:
    http://www.epitan.com.au/news_announcements.aspx?page=2&view=13

    EpiTan announces Human implant trial to begin-Date 16/6/03:
    http://www.epitan.com.au/news_announcements.aspx?view=20

    First Tanning Drug Trial Volunteer Reports “Excellent Results” - Date 5/5/03:
    http://www.epitan.com.au/news_announcements.aspx?page=2&view=17

    Phase II drug study to be completed on Sept 11, results in early Oct. (amended):
    http://stocknessmonster.com/news-item?S=EPT&E=ASX&N=203946

    There are a number of items to be worked on before commercialisation takes place:
    1. Approvals: F&Q:
    http://www.epitan.com.au/melanotan_faq.aspx#1

    Extract:
    "With the Phase II trial underway, Melanotan is at an advanced stage on the path to commercialisation. EpiTan will apply for approval for Melanotan firstly in Australia through the local regulatory authority. Shortly after, applications to Europe and US will be submitted and approval is expected to follow 6-12 months after Australia. It is currently anticipated that Melanotan will be available by prescription in Australia in 2005/2006.

    2. Acceptance of one or more delivery systems. This is being worked on. See this thread and the web site:
    http://www.epitan.com.au/

    Extract:
    "Potential markets worldwide for Melanotan for dermatology purposes are estimated at US$1.5 billion. An even greater market (more than US$5 billion) exists for Melanotan as a new safe (sunless) tanning drug".
    http://www.epitan.com.au/news_announcements.aspx?view=20

    3. Satisfactory arrangement with a Pharma to undertake Phase III (assuming that Phase II will be successful) and look after the commercialisation, possibly with a milestone payment and royalties.

    The nature of any contractual or participatory arrangements will be awaited pending the outcome of Phase II and the application of (a) successful delivery system (s).

    Gerry
    Please do your own research and you decide if and when to buy, hold or sell any stocks.

 
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