Yes, this stock has hit the roof with a sixty percent rise on the Australian stock market (ASX) today. If you don’t know what it’s all about. Its something called SCENESSE®
This has been in the works from 2016 onwards, and the company has put in some research for this and waiting for this to happen, and it ultimately has worked out for them. They have got a FFDA approval in the united states and so the big jump in stock price today.
Stock price: CUV (ASX) $45.00 +16.91 (+60.20%)
Clinuvel gains FDA approval in US
Clinuvel was formerly Australian startup called Epitan, which changed its name to Clinuvel in 2006.
Clinuvel Pharmaceuticals Limited (CUV) is a biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders.
Getting a FDA approval in the united states is like a license to distribute to the rest of the world, factoring the billion-dollar pharma industry in the US. Here is the clinuvel update released today at afr http://member.afraccess.com/media?id=CMN://3A478020&filename=20170919/CUV_01897356.pdf
So what is SCENESSE®
The scenesse drug will assist with TREATMENT FOR ADULT PATIENTS WITH THE RARE METABOLIC DISORDER ERYTHROPOIETIC PROTOPORPHYRIA
SCENESSE, delivered via a subcutaneous dissolving implant the size of a grain of rice, shields against UV radiation and sunlight by increasing the levels of melanin in the skin.
CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe.
Afamelanotide (melanotan I, CUV1647; brand name Scenesse) is a synthetic peptide and analogue of α-melanocyte stimulating hormone used to prevent skin damage from the sun in people with erythropoietic protoporphyria in Europe since January 2015. It is administered as an implant that is placed under the skin; the implant lasts for two months.
The drug Afamelnotide is linked to Melanotan1 and 2. Melanotan II is banned from commercial sale in AUSTRALIA and the Therapeutic Goods Administration last year made it illegal for Australians to buy it from overseas for personal use without a prescription.
A trial was also conducted in the US to test the ability of afamelanotide (Scenesse) to improve the response of vitiligo patients to narrow band UVB (nbUVB).
Scenesse is approved in Europe for the treatment of porphyria, a disease in which patients are very sensitive to sunlight, and it works by making the skin darker through a process similar to tanning, but without exposure to the sun. some countries still have a ban on this treatment and drug
Adults who received the implanted drug reported that they could spend significantly more time in the sun than those who received a placebo implant, although the increase was not always dramatic because people with the condition have developed a powerful aversion to sunlight that is difficult to overcome.
From Wikipedia (interesting facts )
Very early in the process one of the scientists, who was conducting experiments on himself with an early tool compound, melanotan II, injected himself with twice the dose he intended and got an eight-hour erection, along with nausea and vomiting.
To pursue the tanning agent, melanotan-I (now known as afamelanotide) was licensed by Competitive Technologies, a technology transfer company operating on behalf of University of Arizona, to an Australian startup called Epitan
Scenesse is available in Germany, Austria, the Netherlands, Italy and Switzerland
An estimated 45 million patients worldwide suffer from light-sensitive skin disorders that make them potential candidates for SCENESSE.