A few months after winning US Food and Drug Administration (FDA) approval Clinuvel Pharmaceuticals (ASX:CUV) is about to start selling its treatment for a rare skin condition known as anti-erthropoietic protoporphyria (EPP).
EPP causes quick and extreme skin reactions to light exposure. The FDA approval in October came 32 years after the drug was first developed and 18 years after Clinuvel entered the ASX.
The company finally got the green light after three failed attempts to win America’s healthcare regulator over between 1987 and 2005.
Clinuvel expects the first patient will be treated next month, with distribution to start in a handful of hospitals before being ramped up over the next couple of years.
The approval comes six months earlier than the company had previously anticipated.
“You need to work through the entire distribution chain in the US and we reckoned it would take about a year to set up, and keep in mind that we are setting up our distributions,” CEO Phillipe Wolgen told Stockhead.
“But we are not into mediating a third company on our behalf, we distribute directly to hospitals. So we’re not going through the pharmacy chain in the US. So these helped us in accelerating this program.”
Clinuvel also announced important steps ensuring eligible patients would be able to receive treatment.
The treatment will be available under America’s Prior Authorisation system. Under the system, insurance companies agree to pay for treatment before it is carried out because it is medically necessary. Until now, no insurance company has ever covered an EPP treatment.
And secondly, a co-payment scheme for patients has been established.
Other diseases are not going away
While much of the global healthcare industry’s focus is on the coronavirus, Dr Wolgen is quick to point out that while diseases such as EPP may disappear from the public spotlight, they don’t for sufferers.
“We tend to forget when we look at the headlines there are still millions impacted by cancer and strokes. That is not going away – it only disappears from the headlines,” he said.
“In the chronic diseases, they have a right to be treated. They’ve been waiting for decades for a treatment.
“We just need to put more precautionary measures in place for patients to go in and out and get safely home, so that’s what we’re working on. Hence our distribution plan is to open the centres strategically.”
Next target: a disease that affected Michael Jackson
Among the company’s other ambitions for the future is vitiligo, a skin condition that affected Michael Jackson and 45 million others.
The disease causes patches of skin and hair to lose their pigment (colour) and turn white. Clinuvel hopes to eventually use its drug SCENESSE to treat the disease and it has been testing it since 2011.
Dr Wolgen says this is “the next one that is coming”, but explained,”we wanted to get it on the market for one condition then accelerate”.
READ MORE: Dr Boreham’s Crucible: the story of Clinuvel, an Australian triumph