Record revenue and profit for Australian company Clinuvel

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Emerging Australian pharmaceutical company Clinuvel has announced a record profit for the six months to the end of December driven by growth in European and US sales of its treatment for a rare condition that can lead to significant sun damage.

Clinuvel, which now has a market capitalisation of over $1 billion, announced a 50 per cent rise in revenue to $24.6 million and a record profit before tax of $8.7 million.

The company started its first clinical trials of SCENESSE (afamelanotide) in patients with erythropoietic protoporphyria (EPP) in 2007.

EPP is an inherited condition resulting in the accumulation of protoporphyrins in red blood cells that causes acute, painful photosensitivity and potential liver disease. It typically presents in early childhood with immediate pain from exposure to sunlight.

The SCENESSE implant was approved in the European Union in 2014, the US in 2019 and by the Australian TGA in 2020.

At the time it was registered in Australia, Clinuvel said it would "engage" with the Pharmaceutical Benefits Advisory Committee on its potential reimbursement through the PBS. It has never been considered by the committee.

The company said its strong result for the first half of the financial year 2022 reflects "firmer demand" for SCENESSE in Europe and "consistent growth" in the US.

"Patient treatment by European Expert Centres expanded and rising patient treatment in the US is being facilitated by a larger network of Specialty Centers than originally anticipated, as well as acceptance by over 100 US insurers to reimburse the drug under Prior Authorization arrangements," said the company.

“We are on track to build a group relying on financial strength and specific expertise in the family of melanocortin hormones. Afamelanotide is only the first offspring to give Clinuvel a solid foundation for expanding into a diversified and sustainable specialty pharmaceutical," said chief financial officer Darren Keamy.

The company is also developing an injectable form of afamelanotide.