Aura Renew Acq Regulatory News (ARA)

11 Jun 2007 07:00

Ardana PLC11 June 2007 ARDANA ANNOUNCES POSITIVE ASSESSMENT OF EMSELEX(R) BY SCOTTISH MEDICINES CONSORTIUM Edinburgh, UK, 11 June 2007: Ardana plc (LSE:ARA), today announces a positiveopinion from the Scottish Medicines Consortium (SMC) about Emselex (darifenacinhydrobromide). Emselex is a once a day oral treatment for the symptoms ofoveractive bladder (OAB). A positive opinion by the SMC is essential for theintroduction of new therapies within NHS Scotland. The OAB market in the UK is currently estimated to be approximately £90 millionper annum, of which Scotland contributes £10.5 million (IMS Health). Dr. Maureen Lindsay, Chief Executive of Ardana, said: "We are delighted that theSMC assessment of Emselex has been favourable. This will help us to continue togain acceptance for Emselex as an important new treatment option for patientswith OAB" . Emselex was launched in October of last year and is marketed in collaborationwith Novartis Pharmaceuticals UK Limited ("Novartis"). Emselex(R) works by selectively inhibiting the muscarinic M3 receptor, theprimary mediator of detrusor muscle contraction. Symptoms of OAB include urinaryurgency (a sudden and compelling desire to pass urine, which is difficult todefer) with, or without, urge urinary incontinence (involuntary leakageaccompanied or immediately preceded by urgency), usually with urinary frequency(voiding the bladder too often), and nocturia (waking at night one or more timesto void the bladder). Antimuscarinic drugs are often used to treat patients who present with symptomsof OAB, although other therapies such as bladder retraining may also beeffective for some patients. In common with other recently introduced antimuscarinic treatments for OAB, thepositioning of Emselex takes into account cost considerations. The SMC advice,following a full submission reads: "darifenacin (Emselex(R)) is accepted for restricted use within NHS Scotlandfor the symptomatic treatment of urge incontinence and/or increased urinaryfrequency and urgency as may occur in patients with overactive bladder syndrome. Darifenacin is effective in reducing symptoms associated with overactivebladder, including frequency, urgency and incontinence and the treatment effectis similar to another antimuscarinic. Darifenacin is associated with adverseeffects typical of antimuscarinic agents used in this condition. It isrestricted to second line use as there are cheaper antimuscarinics availablethat would normally be used as first-line agents" Full details of the advice are available at the SMC website:www.scottishmedicines.org.uk For more information contact: Ardana Financial DynamicsMaureen Lindsay (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert Tel: +44 (0)20 7831 3113 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development andmarketing of innovative products to improve human reproductive health, a $25.5billion market. Since its foundation, Ardana has built a broad and balanced portfolio to managerisk and actively pursues product and technology in-licensing and outlicensingto maintain a robust pipeline. Ardana's lead products are summarised below: • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome, for which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-07 a growth hormone secretagogue in late stage development for the diagnosis of growth hormone deficiency • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; • Testosterone Cream, a trans dermal testosterone delivery system in development (Phase II trials) for the treatment of male hypogonadism; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. In addition, Ardana has a strong portfolio of follow-on products in development. Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange