Auxilium Phramaceuticals (NASDAQ:AUXL)‘s drug to treat Peyronie’s disease, a condition in which the penis is abnormally curved, has achieved positive phase 3 results, according to a company statement.
If approved, the Malvern, Pennsylvania company’s drug Xiaflex would be the first biologic to combat the disease. The company said two one-year clinical trials to test safety and efficacy produced statistically significant improvements.
One study resulted in 37 percent reduction in penile curvature, while a second study resulted in a 30 percent reduction of curvature.
Peyronie’s disease is a connective tissue disorder that results in the growth of fibrous plaque in the soft tissue of the penis that can cause pain and erectile dysfunction, among other symptoms. It can be associated with diabetes. It affects 5 percent of men, according to a 2007 study cited by the company, but the social stigma associated with the disease can discourage patients from getting diagnosed and treated.
The nature of the condition, which affects about 5 percent of adult men, can lead to sexual dysfunction, emotional distress, loss of self-esteem and depression. Because of the embarrassment associated with the disease and current limitations of treatments, the company estimates that many cases are undiagnosed and untreated. The treatment levels provided by the company would seem to bear that out. Between 65,000 and 120,000 patients with Peyronie’s are diagnosed every year in the U.S., and approximately 5,000 to 6,500 are currently treated with injectable therapies or surgery annually, according to Auxilium.
Adrian Adams, Auxilium’s CEO, said the drug had the clinical profile to become a potential breakthrough procedure for the disease.
Earlier this year, Auxilium inked a $68 million licensing deal with Swiss pharmaceutical company Actelion covering Canada, Brazil, Australia and Mexico.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Xiaflex is currently approved for the treatment of Dupuytren’s contracture, a thickening of the tissue beneath the skin on the palm of the hand and the fingers that makes it difficult or impossible to extend and straighten the fingers.
