They may never go an official cosmetic route and just stick to the 'off-label' markets. They did however produce a topical spray version of melanotan-1 that was to undergo testing in London as announced here in February 1, 2005. One would surmise that they did some unofficial human testing of the topical spray version that demonstrated effectiveness prior to ever investing in the pursuit of the topical trials. Why the results of these tests were never announced or published is puzzling. There are plenty of speculative reasons for why that might have happened. Two of the more prominent would be: 1. Tests proved limited topical effectiveness (ie: there were cosmetic issues in how the drug distributed across the skin). 2. Tests proved too effective and they realized that if news of an effective topical drug for producing cosmetic pigmentation got out then it would be very easy for companies to be inspired to make knock-offs and sell them much in the same way that the peptides are sold now only in much more significant quantities.  
 
 
Once melanotan-1 (under their brand name "Scenesse") is proven safe for general usage there is going to be very little preventing other companies from getting an injectable generic version of the peptide OK'd by governmental health regulatory agencies for usage outside of the indications that Clinuvel is working on due to the fact that the patents on the molecule have expired (and perhaps even a topical administration patent has expired). The question as to whether or not the general public would accept daily injections of melanotan-1 to develop cosmetic pigmentation remains a bit open. I think the example that Botox has set tells us that the answer to this question is a resounding yes. Thousands and thousands of people are prepared to undergo painful injections (Botox injections are not generally too painless) to enhance their appearance so if they could have what would be essentially painless subcutaneous injections to develop attractive photoprotective color they likely would if the cost was not too prohibitive.  
 
 
-Scott

I don't think shareholders should be counting on the development of sanctioned cosmetic usages of Clinuvel's brand of melanotan-1, ("Scenesse") anytime soon. Such a cosmetic market may spontaneously form from doctors deciding to take it upon themselves to use the drug implants in such an off-label way but you won't see Clinuvel promoting that (they could not do so legally in most jurisdictions). In order for such a market to develop med-spa type operations are going to have to be the ones to jump on promoting it via word-of-mouth. Still the question of availability remains. I think the biggest issue for folks looking at future value of their holdings is what will the level of availability be for the implants covering both on-label on off-label markets? I have yet to encounter any sort of analyst report or Clinuvel press release covering what the levels of availability are going to be for the implants.
 
-Scott

Quote from newnameolduser on 06/12/10 at 22:34:59:

 
I think any additional company could only have a generic version of a drug approved for on-label indications for the drug. With orphan drug laws in place I believe that in terms of on-label usage Clinuvel will have a hold on the market for 7 years (in the U.S.) after approval in terms of the drug being used as a treatment for one of the indications they are attempting to establish approval for. If this is indeed the case then no additional company will be in a position to produce a generic version of melanotan-1 for human usage until expiration of the usage of the drug for the initial on-label indication has passed.  
You would do well to consult with an attorney competent for drug laws relative to this question to have a more definitive answer.
 
-Scott

Actually, with health care reform I believe that biologic pharmaceuticals have 12 year market exclusivity instead of 7. Can anyone confirm this for sure? Thats how I interpret it though, and scenesse is considered a biologic pharmaceutical.

Applied for a US Patent to assist drugs potential skin cancer preventative in redheads with defunct MC1Receptors.This must be an indication they have a bigger picture in mind?

I've been a share holder since the very beginning. I've gone up and down. I don't have a lot of answers about whether Clinuvel will ever be a financial success. I have tried to find every piece of information regarding information on the topical spray. There is very little information available. The leadership of Epitan (Clinuvel's former name) and current Clinuvel management is night and day. The Epitan guys were going after larger markets and talking a good game the only problem is they couldn't get the dang thing to market.  
 
Clinuvel's current management on the other hand at least in my opinion is going to secure Marketing Authorization for this compound. The only problem is that I don't think they are going to make any money unless there is significant and I mean significant off label demand. Frankly even the PLE results were clinically dissapointing. So you've got EPP but off the top of my head I remember an analysts report saying EPP would only be worth like .09 cents a share. IMO that is the only disease they will be able to treat. PLE just isn't going to happen. The statistical data from the last clinical trials were incredibly disappointing. PLE was supposed to account for .50-.76 cents per share. That was a fairly common condition and the perfect condition to kind of fudge perscription use through.
 
Now with regards to the topical spray or lotion. The question I'd ask is do you see anyone involved with Epitan still with large stock positions in Clinuvel? I don't think so. Also no information on if that application works as to who owns patents etc...  
 
One thing to consider is that I believe early studies used much larger doses of afamelanotide [melanotan-1] were not toxic. However, (Please fact check me here) I believe that the company found smaller doses were very effective. If they do make it to market I'd expect to see the following products the initial implant, then I'd expect to see a longer term implant developed and finally If they end up able to generate strong revenues I'd look for a spray or lotion but one that is probably administered by a doctor.  
 
I think best case scenario is if they can get this drug in the hands of "cosmetic" nurse practicioners it would be a great product to be administered along botox, dysport, laser hair removal etc... If they can get it there than I think Scenesse becomes a hit.