11 Mar 2014 08:12
11 March 2014
Plethora Solutions Holdings PLC
("Plethora" or the "Company")
Company update
Plethora (AIM: PLE) is pleased to inform shareholders that our recent meeting during Q1 2014 with the United States Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application for PSD 502. Appropriate actions are well underway with the Company's various consultants. Importantly, the FDA has confirmed that premature ejaculation is an area of high medical need with a requirement for effective therapy and recognises the importance of the initiatives that Plethora has made towards this goal.
The Company sees a significant potential market opportunity for PSD 502 both in the United States and EU. Based on the Company's internal modeling and pricing input from its US marketing consultant, the Company forecasts in excess of US$1 billion per annum peak prescription sales. It therefore sees significant value in PSD 502 for the Company's shareholders and correspondingly, management is to looking to unlock that value as quickly as possible through bringing to closure negotiations with potential marketing partners. In this respect, the Company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories. Negotiations are at a more advanced stage with a number of potential marketing partners and the Company is hopeful that an announcement will be made in this regard over the coming months. However, shareholders should please note that given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof.
The Company is also making excellent progress with its preferred manufacturing partner and is hopeful that an announcement will be made within the next month.
Enquiries:
Plethora Solutions Jamie Gibson, CEO Mike Wyllie, CSO Mike Collis, CFO
| Tel : +44(0) 20 3077 5400 |
Daniel Stewart (Nomad & Joint Broker) David Hart / Ciaran Walsh (Nomad) Martin Lampshire (Broker)
| Tel : +44(0) 20 7776 6550
|
Hybridan LLP (Joint Broker) Claire Louise Noyce William Lynne |
Tel: +44(0) 20 7947 4350 Tel: +44(0) 20 7947 4361
|
Britton Financial PR Tim Blackstone | Tel: + 44 (0) 20 7242 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 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 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.