The US Food and Drug Administration (FDA) cleared Auxilium Pharmaceutical’s Xiaflex product to treat Peyronie’s disease, a condition that causes painful curvature of the penis.
Peyronie’s is thought to affect up to 5 per cent of the male population and occurs as a result of chronic inflammation of soft tissues in the penis, leading to the formation of scars or plaques. The plaques can cause pain and curvature of the penis on erection and may make intercourse difficult.
Xiaflex (collagenase clostridium histolyticum) is the first non-surgical treatment to be approved for Peyronie’s disease and is indicated for men who have a palpable plaque that results in a curvature deformity of at least 30 degrees upon erection, according to the FDA.
Auxilium’s stock was up more than 10 per cent on Friday on the back of the FDA announcement, which laid to rest concerns about the viability of the new indication that have in the back of investors’ minds since Pfizer ducked out of a collaboration with Auxilium a few months back.
The company has since signed a deal with Swedish Orphan Biovitrum (SOBI) for the commercialisation of Xiaflex (known as Xiapex in Europe) in 71 ex-US countries.
The product is already approved in the US to treat Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers, and is thought to work by breaking down collagen deposits that form in connective tissue.
There seems to be some crossover between the two indications – around 30 per cent of men with Peyronie’s also develop connective tissue problems in other parts of the body, including the hand, and it is though there may be some genetic component to the disease.
Auxilium’s sales of Xiaflex were around $16m in the third quarter, a rise of 20 per cent with the market share compared to other treatment procedures at around 29 per cent, according to the company’s chief executive Adrian Adams.
The company has not speculated publicly on the impact on sales of approval in Peyronie’s although Adams said recently: “we remain very excited about the potential, given the very high levels of unmet need and the fact that there is nothing else available.”
Meanwhile, Auxilium is also looking at other applications for Xiaflex, and has a phase IIa study ongoing looking at its potential to improve the appearance of cellulite as well as a phase IIb trial in frozen shoulder syndrome.