[ExI] Finally--inject-a-tan upcoming phase-3 testing

[Damien Broderick]

"Suntan coming soon in a syringe near you"

[sorry, no url available]

A DRUG that could give a suntan via an injection 
is a step closer to hitting the market after 
European authorities granted it a special status to speed up its development.

The drug, CUV1647, triggers the production of 
melanin, giving colour to the skin for 60 days 
after a capsule, the size of a rice grain, is injected.

At this stage, the drug is being developed as a 
remedy for erythropoietic porphyria, a genetic 
disease characterised by severe light 
sensitivity, but the possible cosmetic 
applications of the drug are significant.

Among those seeking a suntan, there may be an 
initial reluctance to the injection in the lower back each 60 days.

But at a briefing yesterday, a parallel was drawn 
with botox, developed to treat muscle spasms but 
popularly injected to reduce signs of ageing.

The drug could help prevent skin cancer. There 
are 40,000 cases of the disease diagnosed each 
year and it is common among organ transplant 
patients because of the immune-suppressant medication they take.

Incidence of the genetic disorder are rare ­ 
there are believed to be about 30,000 sufferers 
worldwide ­ making the market unattractive to drug developers.

But this rarity has helped the drug achieve an 
"orphan medicinal product" designation by the 
European Medicines Agency, giving the drug's 
developers benefits including fee reductions, 
access to European approval procedures and protocol assistance.

The drug, made by German-Australian company 
Clinuvel Pharmaceuticals, is due to undergo a 
phase-three trial next year for the genetic 
disorder, the final regulatory hurdle before it 
can be sold in Europe. So far the drug has passed 
the other phases without significant safety concerns.

Clinuvel chairman Roger Aston said there were 
opportunities for "more diverse applications" and 
the company had so far retained all rights to the 
technology. As the product approached 
commercialisation, Clinuvel would work with 
partners with experience and financial muscle 
when it sought to bring it to the market.

Dr Aston said the later in the regulatory 
approval process the company chose to license its 
products, the greater the royalty it would enjoy 
because of the reduced risk of failure.

He said biotechnology companies that licensed 
their products at phase three of clinical 
testing, which Clinuvel is considering, could 
anticipate royalties of between 25% and 60%.

The regulator's decision, which culminated a 
nine-month application process for Clinuvel, was 
a significant step, chief executive Philippe Wolgen said.

"Achieving orphan drug status has always been a 
core company ambition," he said.

Clinuvel closed up 2.5¢, or 7.6%, to 35.5¢ on the 
Australian Stock Exchange yesterday.

The company is also listed on the German DAX and 
trades in the US using American depositary receipts.