Plethora Solutions Holdings Plc Regulatory News (PLE)

19 November 2013

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

European Commission Approval

Plethora Solutions Holdings plc (AIM: PLE) announces that the European Commission has granted marketing authorisation for the Company's treatment for primary premature ejaculation in adult men under the name 'Prilocaine Lidocaine Plethora'. This product is also referred to by the Company under its development code PSD502.

PSD502 was developed by the Company for the treatment of primary premature ejaculation and demonstrated a highly statistically and clinically significant improvement in the primary measures of intravaginal ejaculation latency time (IELT), control and satisfaction in two pivotal, double-blind, placebo controlled phase III studies. In these studies, the product was shown in over 23,000 exposures to be well accepted by patients.

Premature ejaculation is probably the most prevalent sexual dysfunction in men. The condition has been characterised by the International Society of Sexual Medicine (ISSM) as being "a male sexual dysfunction" characterised by: ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy.

The Company estimates that there are in excess of 150 million men aged between 20-69 years old in the European Union. With an estimated incidence of PE of 20-30% of men, this implies that the potential population of men in the EU with the disorder is approximately 30-45 million.

Jim Mellon Chairman of Plethora said:

"Plethora was founded in 2004 to develop PSD502; in 2011 the Company regained control of the European approval process and PSD502 has now been approved by the European Commission. In August this year Plethora regained global control of PSD502 and work is well underway to file with the FDA in early New Year. We are delighted by today's news that represents an important step in the successful commercialisation of the product. Premature ejaculation can cause serious distress for those men who suffer from the condition and we hope that PSD502 will help them and their partners"

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Enquiries:

About Plethora:

Plethora is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk 

Plethora is focussed on seeking to launch PSD502 for the treatment of premature ejaculation.

About PSD502 & Premature Ejaculation:

PSD502 is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. The Company anticipates launch in late 2014.

Premature ejaculation is possibly the most common form of sexual dysfunction in men. Epidemiological studies conducted in the US and in Europe indicate a prevalence of 20 - 30% in men of all ages. There is currently no globally approved and effective pharmaceutical treatment for this condition.

In the absence of any widely approved pharmaceutical therapy with good patient acceptance, the premature ejaculation market offers significant potential for development and growth. An effective drug therapy for premature ejaculation may have a comparable commercial potential to the erectile dysfunction drugs.