Aura Renew Acq Regulatory News (ARA)

16 Nov 2006 07:01

Ardana PLC16 November 2006 ARDANA ANNOUNCES UK LAUNCH OF EMSELEX(R) FOR OVERACTIVE BLADDER Edinburgh, UK, 16 November 2006L: Ardana plc (LSE:ARA), announces today that ithas commenced the marketing in the United Kingdom of Emselex(R), a once a daytreatment for symptoms of overactive bladder (OAB) in collaboration withNovartis Pharmaceuticals UK Limited ("Novartis"). Ardana will be responsible for the launch and ongoing sales and marketing ofEmselex(R) whilst Novartis will be responsible for distribution, medical andpharmacovigilance activities. This follows the announcement on 20th September2006 of an exclusive 10 year UK marketing and promotion agreement between Ardanaand 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 tolaunch and promote this product. The OAB market in the UK is currently estimated to be £82.1 million and isgrowing at 14% per annum (IMS Health). Dr. Maureen Lindsay, Chief Executive of Ardana, said: "We are delighted to have launched Emselex(R) today as it is an important newtreatment option for patients who suffer from this distressing condition." Emselex(R) (darifenacin hydrobromide) is an oral once-daily muscarinic M3selective receptor antagonist (M3 SRA) for the treatment of OAB. Symptoms of OABinclude urinary urgency (a sudden and compelling desire to pass urine, which isdifficult to defer) with, or without, urge urinary incontinence (involuntaryleakage accompanied or immediately preceded by urgency), usually with urinaryfrequency (voiding the bladder too often), and nocturia (waking at night one ormore times to void the bladder). Emselex(R) works by selectively inhibiting the M3 receptor, the primary mediatorof detrusor contraction, whilst relatively sparing the M1 and M2 receptors thatare located in various body organs, including the brain and heart. Emselex(R)has been shown to significantly reduce the number of weekly incontinenceepisodes. Pooled data from Phase III studies showed that the incidence ofcardiovascular adverse events for Emselex(R) was low. Furthermore, a study inelderly healthy volunteers indicated that Emselex(R) did not significantlyimpair memory function. In clinical trials involving more than 10,000 subjects and patients, Emselex(R)has been shown to significantly improve all other key symptoms of OAB across arange of pivotal endpoints. These include the number of times patients had tovisit the bathroom each day, frequency of urgency, severity of urgency and thenumber of incontinence episodes leading to a change in clothing or pads. Consistent with the pharmacological profile of Emselex(R) the most commonlyreported adverse events were dry mouth and constipation, but discontinuationfrom treatment due to these adverse reactions was infrequent. Antimuscarinic drugs are often used to treat patients who present with symptomsof OAB, although other therapies such as bladder retraining may also beeffective. 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 maintained a broad and balanced portfolio tomanage risk and actively pursues product and technology in-licensing andoutlicensing to maintain a robust pipeline. Ardana's lead products are summarised below: • Emselex(R), a once a day treatment for the symptoms of overactive bladder which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis Pharmaceuticals UK Limited; • Striant(TM)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; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; and • Oral GHS (EP01572) a oral growth hormone secretagogue in late stage development in the first indication for the diagnosis of growth hormone deficiency and in early stage development in a second indication. 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