Plethora Solutions Holdings Plc Regulatory News (PLE)

18 Apr 2005 07:00

Plethora Solutions Holdings PLC18 April 2005 For Immediate Release 18 April 2005 Plethora Solutions Holdings PLC Plethora licenses Roche's overactive bladder and benign prostatic hyperplasia compound Roche and Plethora Solutions Plc (Plethora) today announced that Roche hasgranted Plethora an exclusive license to PSD 506, a M2/3 muscarinic receptorsubtype-selective antagonist for overactive bladder in women, and in men withbenign prostatic hyperplasia (BPH). PSD 506 represents the first of a newgeneration of the antimuscarinic drug class, that works by selective and potentantagonism of two receptors important for mediating over-excitability of humanbladders, M2 and M3 muscarinic cholinoceptors. PSD 506 has the potential toimprove the inhibition of hyperactivity in urological tissues, while sparingcommon antimuscarinic side-effects of dry mouth, GI disturbance and dizziness /confusion, which are observed with current therapies in the class. PSD 506 has successfully completed single and multiple dose phase I studies.Over the next 18 months, Plethora will be responsible for the phase II clinicaldifferentiation programs. Under the terms of the agreement, Roche has the rightto opt back into the compound during certain stages of development and, inaddition to royalty payments, may receive up to $69 million. Steven Powell, CEO of Plethora commented, "We are delighted to enter into thisdevelopment agreement with Roche for such an exciting product. This confirms theconfidence that major pharmaceutical companies such as Roche have in thedevelopment expertise of our team at Plethora and we look forward to reportingon the progress of the PSD506 clinical trials in due course." "We are pleased with the potential opportunity to offer patients a new,tolerable and efficacious treatment option through Plethora's continueddevelopment of PSD 506," said Peter Hug, Global Head of Roche Pharma Partnering. About OAB and BPH The estimated population of males and females with moderate and severe symptomsof BPH and OAB is in excess of 40 million. As with other common urologicalconditions, these disorders predominantly affect older patients and thispopulation is projected to grow with increasing life expectancy. The totalmaximum potential market is considered to be $30 billion. Although drugsincluding antimuscarinics are available, there is poor compliance, with highpatient discontinuation, due particularly to dry mouth in OAB patients and theyare contra-indicated in BPH patients. The biological and clinical profile of PSD506 is such that improved patient compliance is anticipated as is approval forthe treatment of BPH. About Plethora Plethora is a UK-based speciality pharmaceutical company focused on thedevelopment of products for the treatment of urological disease. The company hasproducts in clinical development for the treatment of overactive bladder, benignprostatic hyperplasia, stress urinary incontinence and premature ejaculation.The company is headquartered in the UK and recently listed on the London StockExchange (PLE:LN) About Roche as a Partner Roche is a valued partner to over 75 companies worldwide. In the past twoyears, Roche has led the pharmaceutical industry in the number of new clinicalcompound deals signed. In 2004, Roche brought nine potential products into thecompany and strengthened its positions in oncology, virology and primary care.Roche's alliance strategy is to create a partnering culture where innovationflourishes and the partnership grows. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As a supplier of innovative products and services for the earlydetection, prevention, diagnosis and treatment of disease, the Group contributeson a broad range of fronts to improving people's health and quality of life.Roche is a world leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2004 sales by thePharmaceuticals Division totalled 21.7 billion Swiss francs, while theDiagnostics Division posted sales of 7.8 billion Swiss francs. Roche employsroughly 65,000 people in 150 countries and has R&D agreements and strategicalliances with numerous partners, including majority ownership interests inGenentech and Chugai. Additional information about the Roche Group is availableon the Internet (www.roche.com). Roche- EuropeSabrina Oei, Pharma Partnering Tel: +41 61 688 9358 sabrina.oei@roche.comMaria Payne, DeFacto Communications Tel: +44 (0) 207 496 3300 Plethora +44(0)207 269 8630Steven Powell Buchanan Communications Tel +44 (0) 207 466 5000Tim Anderson/Isabel Podda This information is provided by RNS The company news service from the London Stock Exchange