ARDANA ANNOUNCES UK LAUNCH OF EMSELEX®

FOR OVERACTIVE BLADDER

Edinburgh, UK, 16 November 2006:  Ardana plc (LSE:ARA), announces today that it has commenced the marketing in the United Kingdom of Emselex®, a once a day treatment for symptoms of overactive bladder (OAB) in collaboration with Novartis Pharmaceuticals UK Limited (“Novartis”).

Ardana will be responsible for the launch and ongoing sales and marketing of Emselex® whilst Novartis will be responsible for distribution, medical and pharmacovigilance activities.  This follows the announcement on 20th September 2006 of an exclusive 10 year UK marketing and promotion agreement between Ardana and Novartis Pharmaceuticals UK Limited and a Placing and Open Offer raising £11.0 million (gross), part of the net proceeds of which were to be used to launch and promote this product. 

The OAB market in the UK is currently estimated to be £82.1 million and is growing at 14% per annum (IMS Health).

Dr. Maureen Lindsay, Chief Executive of Ardana, said:

“We are delighted to have launched Emselex® today as it is an important new treatment option for patients who suffer from this distressing condition.“

Emselex® (darifenacin hydrobromide) is an oral once-daily muscarinic M3 selective receptor antagonist (M3 SRA) for the treatment of OAB. Symptoms of OAB include urinary urgency (a sudden and compelling desire to pass urine, which is difficult to defer) with, or without, urge urinary incontinence (involuntary leakage accompanied or immediately preceded by urgency), usually with urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).

Emselex® works by selectively inhibiting the M3 receptor, the primary mediator of detrusor contraction, whilst relatively sparing the M1 and M2 receptors that are located in various body organs, including the brain and heart. Emselex® has been shown to significantly reduce the number of weekly incontinence episodes.  Pooled data from Phase III studies showed that the incidence of cardiovascular adverse events for Emselex® was low. Furthermore, a study in elderly healthy volunteers indicated that Emselex® did not significantly impair memory function.

In clinical trials involving more than 10,000 subjects and patients, Emselex® has been shown to significantly improve all other key symptoms of OAB across a range of pivotal endpoints. These include the number of times patients had to visit the bathroom each day, frequency of urgency, severity of urgency and the number of incontinence episodes leading to a change in clothing or pads.

Consistent with the pharmacological profile of Emselex® the most commonly reported adverse events were dry mouth and constipation, but discontinuation from treatment due to these adverse reactions was infrequent.

Antimuscarinic drugs are often used to treat patients who present with symptoms of OAB, although other therapies such as bladder retraining may also be effective.

For more information contact:

back to top