Clinuvel Pharmaceuticals Ltd (ASX: CUV) is making headlines this week, as investors watch its share price with anticipation following a series of positive announcements made about the company’s future treatment offerings. Clinuvel Pharmaceuticals is a global biopharmaceutical firm focused on the development and delivery of treatments to patients suffering from severe genetic and skin disorders. Based in Australia and headquartered in Melbourne, Clinuvel operates globally operating in the European Union, US, and Singapore in addition to Australia where photomedicine and photocare patient groups range in size from 5,000 to 45 million worldwide. Clinuvel treats these patient groups with its lead product, a compound called SCENESSE which it develops for the treatment of pigmentary disorders as well as the prevention of phototoxicity.
It has been an exciting start to the week for the company, Clinuvel opened on a 43% increase trading at a high of $40.07 per share this morning with a market cap of $1.38 billion following market clearance by the US Food and Drug Administration (FDA) for the use of SCENESSE in the US. The drug (afamelanotide 16mg), has been developed and distributed in-house by the company for the treatment of erythropoietic protoporphyria (EPP), a rare inherited metabolic disorder which causes patients to suffer from an acute intolerance to light. EPP complicates patient wellbeing by triggering painful swelling and burns from exposure to the sun, including further complications which could lead to liver failure. SCENESSE, however, has successfully treated over 800 patients across more than 20 clinical trials, showing a strong indication that the drug is well tolerated and reduces the incidence and severity of phototoxic reactions in patients suffering from EPP. SCENESSE has become the leading product in the treatment of EPP and facilitates pain-free sun exposure and general improvement in the quality of life for those suffering from the disease.
The drug had previously been approved by the European Medicines Agency for the treatment of EPP and generated strong revenue year after year for the company. Consequently, the decision by the FDA to approve the use of SCENESSE in the US market has been seen as a major expected boost to sales for Clinuvel in FY20. Clinuvel Chief Scientific Officer Dr Dennis Wright responded to the announcement this morning by expressing that
"Today is a memorable day and victory for EPP patients, their families, and the global medical community"
Clinuvel has previously been financially sound thanks to healthy revenue from SCENESSE scales in the EU, boasting a 40% increase in net profit before tax in FY19 compared to the previous year. The new announcement is expected to repeat these impressive results in the coming years.
This is following on from an announcement made on 7th October 2019 where an employment agreement with the existing Chief Executive and Managing Director Dr Philippe Wolgen was renewed. Dr Wolgen has held a long-term track record with the company for consistent delivery of business objectives and is expected to continue developing SCENESSEE as part of their strategy.
This article has been prepared by the Australian Stock Report Pty Ltd (AFSL: 301 682. ABN: 94 106 863 978)
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