1 Jul 2013 12:07
1 July 2013
Plethora Solutions Holdings PLC
("Plethora" or the "Company")
AGM Statement & PSD502 Regulatory Update
Plethora Solutions Holdings plc (AIM: PLE), announces that at the Company's AGM held today Jim Mellon, Chairman, made the following statement.
To date in 2013 Plethora has reshaped its business and board and is focusing its entire effort on the delivery of value from PSD502 a treatment for Premature Ejaculation. Considerable progress has been made against this objective.
The Company can today report that it has received from the European Medicines Agency ("EMA") the Day 180 List of Outstanding Issues ("LOOI"). This formal response is in line with late stage procedures in the approval process. Based on established timelines the Company expects the decision in relation to marketing authorisation by the end of 2013, and, if granted, this would allow marketing to commence in 2014.
Concurrent with the approval process the Company has significantly increased its business development activities with the objective of securing one or more partners to market PSD502 not only in the EU but other territories under the Company's control. Discussions have commenced with a number of companies, however, the timeline for agreement and likely structure and quantum of any transaction is hard to determine at this stage. It is the Company's objective to secure a marketing partner before the end of 2013.
The Company announces that all resolutions set out in the notice of the AGM were passed at the meeting today.
-Ends-
Enquiries:
Plethora Solutions Ronald Openshaw, CEO | Tel : +44(0) 20 3077 5400 |
Daniel Stewart (Nomad & Joint Broker) David Hart / James Felix (Nomad) Martin Lampshire (Broker) | Tel : +44(0) 20 7776 6550
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Hybridan LLP (Joint Broker) Claire Louise Noyce/ Deepak Reddy | Tel: +44(0) 20 7947 4350
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Britton Financial PR Tim Blackstone | Tel: + 44 (0) 20 7241 9786 +44 (0) 7957 140416 |
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 launchPSD502 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 product has completed all clinical testing and has been submitted for approval in Europe with the EMA. The Company anticipates launch in late 2013 or early 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.