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Clinuvel Pharmaceuticals: Imminent Milestones Confirmed

|Includes: Clinuvel Pharmaceuticals Ltd. ADR (CLVLY)
Thoroughly reading company annual reports can quite often be good substitutes for sleep aids. But Clinuvel’s 2009 Annual Report, which was released on October 16, contained an exceptional amount of interesting insights on the Company’s strategic direction for the coming year.
For starters, the Company has confirmed in its annual report that they are planning on starting a Phase III EPP confirmatory trial in the US for their photoprotective drug, afamelanotide. This would be dependent on pending FDA approval and on successful results from the current EPP Phase III trial in Europe that is due to end toward the end of 2009.
This is very significant news. The Company had obtained their FDA IND way back in January but US trials still had not yet commenced. It was originally anticipated that Clinuvel would start a Phase II trial in the US. But if the FDA green lights a Phase III trial for EPP, the company could file their MAA in the US much earlier than was originally thought. 
The timeline in Clinuvel’s annual report shows that at this time, they anticipate filing an MAA with the FDA as early as Q4 2010. This is of course pending FDA approval of the Phase III trial and successful completion and results from that trial. 
Clinuvel’s CEO, Dr Philippe Wolgen, in his letter to the shareholders, mentioned that the Company is reviewing all options – including the go-it-alone route – in terms of the anticipated commercial distribution of afamelanotide. This is significant because most shareholders had anticipated the company would almost assuredly take on a licensing partner (which they may indeed end up doing anyway).  But it’s good to hear from the CEO that shareholder value will be a significant factor in commercial deliberations.
In the annual report, the Company also mentioned that further research activities on afamelanotide may come to light as scientific information is generated from the ongoing research.   After years of testing, the Company is still learning about other potential benefits of this photoprotective drug.
Finally, the Company mentioned that “The decision to remain a single-drug company or to expand will dictate any further activities.” This brings about an exciting prospect: Could Clinuvel, which as been deemed a one-trick pony, add additional drugs to its pipeline down the road with its reserved capital? Upon the success of afamelanotide, could it possibly acquire a smaller biotech company down the road or collaborate with another biotech company that has a complementary photoprotective or dermatological project? 
While most annual reports are yawners, Clinuvel’s annual report is worth taking the time to review.

Clinuvel Stock Outlook:
Clinuvel’s stock is still trading at a deep discount and it has been in hibernation for several months, trading in a very tight range with relatively low volume. But in the coming months, there is going to be a steady stream of significant news coming. If the EPP Phase III results are solid, the Company will be gearing up with the branding and pricing of afamelanotide, and final strategic decisions on the distribution of the drug.
The past calendar year has been a slow year for Clinuvel in terms of news flow. But the next 12 months will have more significant announcements than the past few years combined. Key commercial decisions will be made in the coming months.
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Disclosure: Long Clinuvel