Benign prostatic hyperplasia (BPH or enlarged prostate) is a $5 billion market with more than 4 million patients treated each year in the U.S. alone. Despite available pharmaceutical treatments and surgical options, no single solution provides quick, long-term relief of symptoms without unwanted side effects.

Benign prostatic hyperplasia (BPH) is an enlarged prostate gland often resulting in a constricted or partially blocked urethra that can lead to pain, discomfort and other complications with urinating.

BPH occurs in almost all men as they age. If untreated, it can lead to urinary problems such as:

• Trouble starting and stopping urination
• Frequent and irregular needs to urinate, particularly in the night while sleeping
• A weak urine stream
• Painful urination or urinary retention, leading to bladder infections or stones or kidney damage

Fifteen million men in the US and Europe suffer from symptoms of BPH, with approximately 5 million diagnosed in the US alone. And while 4 million men are prescribed pharmaceuticals for BPH in the US each year, these treatments lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. With current pharmaceutical treatments, symptoms will usually return if medication is discontinued. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH. However, any type of prostate surgery can cause side effects, such as semen flowing backward into the bladder (retrograde ejaculation), loss of bladder control (incontinence) and impotence (erectile dysfunction). There is a demand for better balance between efficacy, safety and quality of life.

The lead drug candidate at Sophiris, PRX302, is designed to be a single treatment for the long-term relief of BPH symptoms, without causing sexual dysfunction or sacrificing quality of life.