FDA approves Auxilium erectile treatment

Posted: December 08, 2013

Commercials for erectile dysfunction drugs seem to be part of every televised sporting event, so why not curvature of the penis?

Chesterbrook-based Auxilium Pharmaceuticals Inc. certainly hopes to be part of such discussions whenever or wherever they occur. The specialty drugmaker got a boost Friday when the U.S. Food and Drug Administration approved the company's Xiaflex medication for Peyronie's disease, the first such approval for that condition.

Named for Fran├žois Gigot de la Peyronie (1678-1747), the first-surgeon to King Louis XV of France, the condition involves the development of plaque in parts of the penis that causes bending when it is erect. This can make sexual intercourse problematic.

Xiaflex was approved by the FDA in 2010 to treat Dupuytren's contracture, a condition that results in permanently bent fingers. Auxilium's sales for Dupuytren's patients were less than it expected, at least partly because some orthopedic hand specialists were not inclined to prescribe it, since they would get paid more for surgery.

"It was certainly a change of paradigm for hand surgeons," Auxilium chief executive officer Adrian Adams said.

Xiaflex would be delivered in tiny amounts by injection, but Auxilium hopes urologists and patients see the tiny needle as the lesser evil compared with a scalpel.

"Urologists and patients do not want to have surgery, and that is a major difference," Adams said. "This is why this is so exciting for our company."

Founded in 1999, Auxilium has about 660 employees, with 160 of them in Chesterbrook and 130 at a manufacturing facility in Horsham.

The company has been in a bit of flux, so new revenue from Xiaflex will help. Auxilium went from a net loss of $32.9 million in 2011 to a profit of $85.9 million in 2012. But it posted a first-quarter loss in 2013. Then in April, it bought privately held Actient Holdings for $585 million. That bumped Auxilium's product list from two to 12. But earlier this week, it lost a key patent case involving its testosterone-replacement drug Testim.

In buying Actient, Auxilium acquired 40 sales reps with experience in men's sexual-health products, and it added about 20 in anticipation of selling Xiaflex.

Drug companies have been known to overestimate the population of people needing a drug, but Auxilium says the drug might be of use to 65,000 to 120,000 men per year. The company frets that men, even when they see one of America's 8,000 urologists, don't even mention this particular problem. To spur discussion and sales of a treatment that will cost about $20,000 per year per patient, Auxilium launched a marketing campaign called "Ask About the Curve."


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