Plethora Solutions Holdings Plc Regulatory News (PLE)

11 November 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Company Update

Plethora Solutions Holdings PLC (AIM: PLE) announces that during its US Institutional Investor roadshow in New York and Boston this week it will be:

· Confirming the significant potential market opportunity for FORTACIN™ both in the United States and European Union (EU). Based on estimated market sizes, pricing input from its US marketing consultant and other internal estimates, the Directors of Plethora believe forecast peak prescription sales (end user sales) could reach in excess of US$1 billion per annum for FORTACIN™

· Providing background on the potential pricing of FORTACIN™ in the five largest pharmaceutical markets in the EU and the US. This will show that the Company anticipates a fairly wide variance in pricing in these markets and that the pricing of FORTACIN™ in the EU is expected to be lower than in the US. The price per dose is expected to be between US$6 to US$10 in the EU and approximately US$17 per dose in the US.

· Clarifying and confirming the anticipated timelines relating to the NDA filing and potential approval of FORTACIN™ in the US. The Company expects to complete the filing of the FORTACIN™ NDA incorporating the new can size (6 doses, 3 sprays per dose) by Q4 2015 /Q1 2016. Once the filing has been made the Company anticipates a 10 month Prescription Drug User Fee Act review with commercial launch in the US expected in 2017.

Shareholders / potential investors can view the complete US roadshow presentation on the Investor Relations section of the Company's website:

http://www.plethorasolutions.co.uk/investors-rules.php

About FORTACIN™ & Premature Ejaculation:

FORTACIN™ is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. In two large, double blind, pivotal Phase III studies FORTACIN showed a highly significant and clinically meaningful effect increasing mean intravaginal ejaculatory latency time at baseline from 0.5 minutes to 3.2 minutes at week 12. 87% of the patients in the studies were considered as responders with the product being well tolerated with no significant safety issues. FORTACIN™ also showed positive effects across a wide range of other parameters including partner satisfaction. FORTACIN™ was approved by the European Commission in November 2013.

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% to 30% in men of all ages. There is currently no globally approved and effective pharmaceutical treatment for this condition.

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

About Plethora

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

Plethora is focused on commercialising FORTACIN™ for the treatment of premature ejaculation with strategic marketing partners and obtaining NDA approval for FORTACIN™ with the FDA.