ARDANA ANNOUNCES POSITIVE ASSESSMENT OF EMSELEX® BY SCOTTISH MEDICINES CONSORTIUM

Edinburgh, UK, 11 June 2007:  Ardana plc (LSE:ARA), today announces a positive opinion from the Scottish Medicines Consortium (SMC) about Emselex (darifenacin hydrobromide). Emselex is a once a day oral treatment for the symptoms of overactive bladder (OAB). A positive opinion  by the SMC is essential for the introduction of new therapies within NHS Scotland.

The OAB market in the UK is currently estimated to be approximately £90 million per annum, of which Scotland contributes £10.5 million (IMS Health).

Dr. Maureen Lindsay, Chief Executive of Ardana, said: “We are delighted that the SMC assessment of Emselex has been favourable. This will help us to continue to gain acceptance for Emselex as an important new treatment option for patients with OAB” .

Emselex was launched in October of last year and is marketed in collaboration with Novartis Pharmaceuticals UK Limited (“Novartis”).

Emselex® works by selectively inhibiting the muscarinic M3 receptor, the primary mediator of detrusor muscle contraction. 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).

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 some patients.

In common with other recently introduced antimuscarinic treatments for OAB, the positioning of Emselex takes into account cost considerations. The SMC advice, following a full submission reads:

“darifenacin (Emselex®) is accepted for restricted use within NHS Scotland for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Darifenacin is effective in reducing symptoms associated with overactive bladder, including frequency, urgency and incontinence and the treatment effect is similar to another antimuscarinic. Darifenacin is associated with adverse effects typical of antimuscarinic agents used in this condition. It is restricted to second line use as there are cheaper antimuscarinics available that would normally be used as first-line agents”

Full details of the advice are available at the SMC website:  www.scottishmedicines.org.uk

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