Plethora Solutions Holdings Plc Regulatory News (PLE)

07 October 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

PSD502™ to be marketed as "Fortacin" throughout the EU

LONDON, ENGLAND (07 October, 2014) - Plethora Solutions Holdings PLC (AIM: PLE) is pleased to announce approval by the European Medicines Agency ("EMA") of the product name "Fortacin" for the purpose of marketing PSD502™, the Company's topical spray treatment for premature ejaculation, throughout the European Union ("EU").

Fortacin will be marketed in the EU by Recordati (Reuters RECI.MI, Bloomberg REC IM), under the terms of a licensing agreement (the "Agreement") announced on 16 September 2014. The Agreement grants Recordati the rights to commercialise PSD502™ in the EU, along with Russia, the Commonwealth of Independent States (C.I.S), Turkey and certain countries of North Africa (the "Recordati Territory").

Recordati is an international pharmaceutical group operating a large and efficient field force of medical representatives promoting innovative pharmaceuticals in the urogenital and other therapeutic areas. Under the Agreement Recordati will pay Plethora upfront and potential milestone payments of up to €46 million plus tiered percentage royalties on net sales, ranging from mid-teens to mid-twenties for 10 years from first commercial sales of Fortacin in the Recordati Territory. Plethora expects to receive the first upfront payment of €5 million by 20 October. Recordati will also assume all costs associated with sales and marketing programmes in support of the commercialisation of Fortacin in its territories.

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.

The Company is also continuing to make good progress with its proposed New Drug Application ("NDA") for PSD502™, for submission to the United States Food and Drug Administration ("FDA") and is working towards submitting an NDA by the end of 2015. The Directors believe a licensing agreement for the large US market is unlikely to be conditional on the submission of an NDA and the Company is hopeful of securing such an agreement ahead of submission.

Jamie Gibson, CEO of Plethora, stated, "We are pleased to have received approval for the marketing of PSD502™ under the brand name Fortacin in the EU. This approval, together with the recently announced licensing agreement with Recordati to sell and market Fortacin paves the way for the product's commercial launch. Under the agreement with Recordati, Plethora expects to receive an attractive flow of milestone payments and royalties as sales build. In addition, we are working hard to create additional long-term shareholder value from PSD502™ through further licensing deals, including in the large and highly developed US market, where we are progressing towards submission to the FDA."

About PSD502™ & Premature Ejaculation:

PSD502™ 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 PSD502™ 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. PSD502™ also showed positive effects across a wide range of other parameters including partner satisfaction. PSD502™ 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 commercializing PSD502™ for the treatment of premature ejaculation with strategic marketing partners and obtaining NDA approval for PSD502™ with the FDA.

About Recordati

Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of around 4,000, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in the main European countries, in Russia, in other Central and Eastern European countries, in Turkey, in North Africa and in the United States of America. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialised business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties within the urogenital therapeutic area and of treatments for rare diseases. Consolidated revenue for 2013 was € 941.6 million, operating income was € 195.4 million and net income was € 133.7 million. Further information is available at http://www.recordati.com.

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