Plethora Solutions Holdings Plc Regulatory News (PLE)

10 November 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Receipt of €5 million Upfront Licensing Agreement Payment from Recordati

Plethora Solutions Holdings PLC (AIM: PLE) is pleased to announce that it has received the €5 million upfront payment from Recordati as per the terms of their licensing agreement (the "Agreement") for FORTACIN™ (PSD502™) announced on 16 September 2014. The Agreement grants Recordati the rights to commercialise FORTACIN™ in the European Union, along with Russia, the Commonwealth of Independent States (C.I.S), Turkey and certain countries of North Africa. FORTACIN™ is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. FORTACIN™ was approved by the European Commission in November 2013.

As announced by the Company on 16 September 2014, under the terms of the Agreement in limited circumstances, including the submission of a satisfactory feasibility report to Recordati by 31 December 2014, a portion of the upfront payment may have been refundable to Recordati and the Agreement could have been terminated. The Company is pleased to announce that following delivery by the Company to Recordati of a satisfactory feasibility report, that Recordati has confirmed that no refund is payable by the Company and that Recordati has no intention of terminating the Agreement.

Plethora is also pleased to report that its manufacturing partner Pharmaserve North West Limited (PSNW) expects to complete production of the first GMP batch of the six dose canisters of FORTACIN™ in a few days time. PSNW plans to start the second GMP batch next week and as a result we remain on track to complete the batch stability and validation studies required for EU variation approval for the six dose canister by the end of 2014. Following completion of these studies, an application will be submitted to the European Medicines Agency (EMA) for approval of a variation of the existing Marketing Authorisation for the new six dose canister of FORTACIN™.

The Company continues to expect EMA's Committee for Medicinal Products for Human Use (CHMP) approval for FORTACIN™ during Q3 2015. It is this marketing authorisation that will trigger the immediate commercial launch of the product in Europe by Recordati.

US Investor Roadshow

Plethora's management team will be undertaking a non-deal US roadshow with institutional institutions in New York and Boston this week. Shareholders / potential investors will be able to view the presentation shortly by visiting the Investor Relations section of the Company's website: http://www.plethorasolutions.co.uk/investors-rules.php

Jamie Gibson, CEO of Plethora, stated, "We are pleased to have received the €5 million upfront payment from Recordati as per the terms of the licensing agreement for FORTACIN™ signed in September. We are also encouraged by the progress being made by our manufacturing partner PSNW which means we remain on track to meet our goal of gaining approval of a variation of the existing Marketing Authorisation from EMA for the new six dose canister of FORTACIN™ in Q3 2015. This approval would trigger the launch of the product by Recordati in the EU and the potential start of an attractive flow of milestone payments and royalties to Plethora as the sales of FORTACIN™ build.

We are looking forward to our upcoming US institutional investor roadshow as we seek to build a greater understanding of the significant potential commercial opportunity for FORTACIN™ with this important investor audience."

Plethora has retained full commercialisation rights to PSD502™ for the rest of the World, and is continuing negotiations for licensing agreements with other potential strategic commercial partners in North America, Latin America, the Asia Pacific Region, the Middle-East and Sub-Saharan Africa. The Company is hopeful that an announcement(s) regarding these licensing negotiations will be made during the remainder of 2014.

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.