Plethora Solutions Holdings Plc Regulatory News (PLE)

2 Jul 2007 07:01

Plethora Solutions Holdings PLC02 July 2007 Product Update - Invicorp(R) (PSD510) for erectile dysfunction £€4m new funding to complete development and approval •Final product registration studies to start before year end •Product launch anticipated in 2009 Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the developer ofspecialist products and therapeutics for the treatment and management ofurological disorders, today announces that it has secured £4 million in asecured loan from ETV Capital S.A. ("ETV"). This additional funding will allowPlethora to complete the clinical development and filing for US market approvalof Invicorp(R), a potential treatment for erectile dysfunction (ED). Plethoralicensed the exclusive North American rights to Invicorp(R) from Senetek PLC inFebruary 2006. In February 2007, Plethora announced its intention to initiate the Phase III trial for Invicorp(R) and recent meetings with the FDA have confirmed the path to submission of the NDA for Invicorp(R) as a front-line therapy for erectile dysfunction (ED): •The final product registration studies will be initiated before year end and will be completed within 15 months. •Product launch in the US is anticipated by the end of 2009. In line with its commitment to manage its product portfolio to focus on revenue growth that will lead to profitability, the launch and commercial development ofInvicorp(R) will be undertaken by Plethora's own urology-focused sales and marketing operation in the USA, Timm Medical. The anticipated launch of Invicorp(R), together with the retention of US co-promotion rights for PSD502 for premature ejaculation (PE) in its recently announced licensing agreement with Sciele Pharma Inc., are key components in Plethora's strategy to further leverage Timm Medical's dedicated sales and marketing infrastructure to market speciality therapeutics to urologists. Plethora expects the Timm Medical sales force to be marketing first line therapies for both ED and PE, in addition to its current, profitable range of medical devices, by the end of 2009. Invicorp(R) is administered by intracavernosal injection and has alreadydemonstrated key points of differentiation over the market leader, injectablealprostadil. The market for non-oral drugs is an important, growing segment ofthe total ED market where existing oral treatments are associated with a numberof side effects and are contra-indicated for a large number of individualsincluding those with diabetes and those receiving nitrate therapies for angina. The £4m convertible loan facility has a 39 month term with repayment scheduledto start in early 2008. The full amount of the loan has been drawn down onclose. The convertible converts at the then prevailing market price capped at188p. The aggregate of all conversions, under any circumstances, shall notexceed 10% of the prevailing market capitalisation. Dr. Steven Powell, Plethora CEO, commented: "Following the recently concludedlicensing agreement for PSD502 in the US, we are pleased to have secured thisadditional funding which enables us to complete the development and filing forregistration of Invicorp, which we in-licensed in 2006. Through Timm Medical we have an established route to our target market for new,speciality therapeutics as well as continuing to grow revenues from the sale ofmedical devices. This allows us to retain a greater share of the value createdin our development pipeline. These are important steps towards our goal of building a sustainable,urology-focused specialty pharmaceutical company." A spokesman for ETV commented that this convertible loan facility aims to givePlethora the financial flexibility to execute on their current business planwith confidence and to complete the clinical development and filing for USmarket approval of Invicorp(R). -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel: 020 7861 3838DeFacto CommunicationsRichard Anderson About Plethora: Plethora is focused on the development and marketing of products for thetreatment of urological disorders. The Company has products in clinicaldevelopment for the treatment of overactive bladder, stress urinaryincontinence, interstitial cystitis, gynaecological pain, erectile dysfunctionand premature ejaculation. In January 2006, Plethora acquired Minneapolis (Mn)based Timm Medical Technologies Inc which markets products for the treatment oferectile dysfunction (ED) to urology clinics through a US-based specialty salesteam. The Company is headquartered in the UK and is listed on the London StockExchange (AIM:PLE) Further information is available at www.plethorasolutions.co.uk Invicorp(R) is a patented injectable combination of phentolamine mesilate andvasoactive intestinal polypeptide. Published clinical data indicate that theefficacy and local tolerability profile of Invicorp(R) compare favourably withcurrent non-oral drug treatment options for the treatment of ED. The product hasmarketing authorisation in Denmark and was launched there in September 2006.Invicorp(R) has also been approved in the UK and New Zealand. The ED market is dominated by the oral phosphodiesterase (PDE5) inhibitor drugs.Although these are reported to be effective in around 70% of ED patients, oralED drugs cannot be taken by men who require nitrate medications for angina andtheir effectiveness is substantially reduced in diabetic patients and in thoserecovering from prostate cancer or pelvic surgery. Plethora estimates that thereare over 5.9 million men in the US alone for whom oral ED drugs are not a viabletreatment option. Non-oral ED drug sales exceeded $31 million in the US in 2005(IMS data). Upon approval, Invicorp(R) could be the first novel non-oral EDtreatment to enter the North American market in over a decade. About ETV Capital S.A. ETV Capital S.A. is a specialty finance company that makes supportiveinvestments in growing technology companies across Europe. www.etvcapital.com This information is provided by RNS The company news service from the London Stock Exchange