CUV 0.85% $29.70 clinuvel pharmaceuticals limited

+ progress and expectations +

  1. 22,691 Posts.
    So, what stage are we at?
    This is their Announcement(pdf):

    1. The current phase II trial to complete on Sept. 11 and a preliminary report to be issued early Oct.
    2. EPT to approach the FDA for the purpose of beginning trials in the US using implants.
    3. The Implant trial started in Australia some time ago.
    4. EPT is actively discussing Commercialisation with a suitable Partner.
    5. And is to accelerate the trial program. Presumably, they are referring to Phase III also.

    Comments: Current thinking is that EPT will select a Partner who will finance Phase III (or most of it) and then look after the commercialisation with a milestone payment to EPT and royalties to come.

    Products will be implants and lotions. The latter is being looked at. No side effects are expected as the molecule of the drug is too large to penetrate the very deep layers below the skin.

    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".

    So the Phase II trial completes on Sept. 11, only some 3 weeks away and then another 4 weeks to preliminary results.

    How expensive will Phase III be? I expect EPT's prospective Parner to pay for that but it certainly is nowhere near as expensive as say Cancer trials, where many patients stay at hospital.

    In the EPT case, volunteers will visit the clinique and they leave again. They will need to call in now and then for monotoring.
    What is the demand for tanning?
    I would say it is huge. The tanning salons in the US are busy (from a broker):

    "It is estimated that 28 million American visit tanning
    salons each year, of which there are an estimated 20,000 outlets. The average charge per 10-15 minute sunbed tanning session in the US is about US$7-8.

    Given that it takes 6-10 sessions to achieve a decent tan, the average salon tan costs the consumer between US$42 and US$80.

    And these just solariums; there is a fair risk of picking up a skin cancer there as well. And the petrol and time wasted.

    EPT is developing a lotion. Then in the comfort of one's home it can be applied and in nearly all cases a tan will appear within a week as far as I know. This means that officeworkers wanting to go to the beach can apply a tan previously and don't have to pick up so many damaging ultraviolet rays.

    And now they are working on implants each lasting 6 months.

    Then you can have a tan winter and summer!
    And you will have less chance of skin cancer as well.

    Will there be a demand for this? I bet it will be huge.

    But the last words go to this writer:


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