OVERACTIVE BLADDER AND URINARY INCONTINENCE

Overactive Bladder (OAB) is a disorder characterised by urinary frequency, nocturia, and urgency, associated or not with incontinence episodes. Approximately 16% of the population aged 40 or older has overactive bladder symptoms. Only 20% of the patients are diagnosed, and only 9% of these are drug-treated. The OAB market potential is expected to reach $4.2 billion by 2009.

Urinary incontinence is also a disorder afflicting a high proportion of the population, arising from loss of bladder control. It can happen to anyone, but is very common in older people. At least 1 in 10 people aged 65 or older suffer from this problem. The two most common forms are urge-related incontinence and stress-related incontinence.

Urge urinary incontinence (UUI) is defined as an involuntary loss of urine associated with an urgent and pressing need to urinate. The mainstay treatment for OAB and urge incontinence relies on antimuscarinic drugs that act directly on the bladder muscle. Their major side effect, dry mouth, severely limits market acceptance. The recent approvals of new antimuscarinic agents and/or extended-release formulations of existing drugs confirm the market potential of this indication. These new drugs and formulations, while they slightly improve the side-effect profile, are however still based on the same mechanism of action and do not represent a novel therapeutic option for the urologist or the general practitioner.

A new treatment for these indications, such as besipirdine, with a different mechanism of action from that of antimuscarinics, could reach blockbuster sales over 1 billion euros and represents an outstanding opportunity for any urology-oriented biopharmaceutical companies. The market for OAB alone is estimated to be in excess of €500M per annum.

Stress urinary incontinence (SUI) is the most widespread form, in particular in women. It is characterized by an involuntary loss of urine, not preceded by the need to urinate, which occurs during a stress such as coughing, laughing, sneezing, jumping, running, lifting heavy loads of any other physical activity that increases intra-abdominal pressure. In stress urinary incontinence, new pharmacological treatments are also awaited. The therapeutic approaches for stress urinary incontinence are based on perineal-sphincter rehabilitation, alone or combined with biofeedback or with electrostimulation. In the case of very debilitating stress urinary incontinence a surgical treatment can be proposed.

Until recently, there was no frontline pharmacological treatment for stress incontinence. If rehabilitation fails, oestrogen replacement therapy and/or the use of alpha-adrenergic compounds can be prescribed in menopausal women. Tricyclic antidepressants such as imipramine have also been used.

The only treatment approved specifically for stress incontinence in the European Union is duloxetine (Yentreve®), a balanced inhibitor of serotonin and norepinephrine uptake. Preclinical and clinical studies have shown that this compound enhances urethral closure and conserves bladder-sphincter coordination. On the other hand, this compound has adverse effects which greatly limit its use.

UROLOGICAL CARCIMONAS

The two most common urological cancers, i.e. prostate, and bladder cancers represent growing markets with large unmet medical needs, surgery remaining the first and main therapeutic approach.

Prostate cancer is one of the most common cancer types in men, constituting approximately 30% of all cancers in men. Sales of prescription drugs to treat prostate cancer reached US$ 3 billion in 2005 in the major pharmaceutical markets and is expected to reach more than US$ 7 billion in less than 10 years. The number of bladder cancers diagnosed in the US has increased by 33 % over the past 15 years. It is the fourth most common cancer in men after prostate, lung and colorectal cancers. Treatment for bladder cancer depends on the stage of the disease, the type of cancer, and the patient’s age and overall health. Options include surgery, chemotherapy (valrubicin, mitomycin, and doxorubicin), radiation, and immunotherapy (BCG).