Plethora Solutions Holdings Plc Regulatory News (PLE)

16 September 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Plethora Signs Licensing Agreement with Recordati to commercialise PSD502™, a novel treatment for premature ejaculation

Plethora expected to receive upfront and milestone payments of up to €46 million plus royalties

LONDON, ENGLAND (16 September, 2014) - Plethora Solutions Holdings PLC (AIM: PLE) today announces that it has entered into a license agreement (the "License Agreement") with Recordati ( Reuters RECI.MI, Bloomberg REC IM), an international pharmaceutical group, granting Recordati the rights to commercialise PSD502™, Plethora's novel treatment for premature ejaculation, in Europe, Russia, the Commonwealth of Independent States (C.I.S), Turkey and certain countries of North Africa (the "Recordati Territory"). Plethora will retain full commercialisation rights for PSD502™ for the Rest of the World, including but not limited to the US and Canada, Latin America, the Asia Pacific region, the Middle East and Sub-Saharan Africa.

Under the terms of the License Agreement Plethora will receive:

· a payment of €5 million on the date on which the agreement becomes effective (see below) (the "Upfront Payment");

· a payment of €6 million upon grant of variant approval from the European Medicines Agency for a new six dose can (the "Agreed Variations Payment");

· a payment of up to €10 million in total upon first commercial sales of PSD502™ in France, Germany, Italy, Spain and Portugal (being payment of €2 million for each of these 5 countries);

· up to €25 million in aggregate in sales-based milestones ("Milestone Payments", see below for further details); and

· tiered percentage royalties on net sales, ranging from the mid-teens to the mid-twenties for 10 years from first commercial sale, and thereafter at a single digit percentage royalty rate.

Shareholders and investors should read the whole text of this announcement.

The License Agreement shall be effective from the date upon which agreements terminating the existing licensing and patent agreements with Shionogi, Paul Royalty Fund Holdings II and Dr Richard Henry (together the "Cessation Agreements and Patent Transfer Agreement", further details of which are set out in the Company's announcement dated 29 August 2014) have become wholly unconditional, provided that this takes place by 30 September 2014. The final completion condition of the Cessation Agreements and Patent Transfer Agreement is receipt of funds. This completion condition is expected to be met shortly after announcement of completion of the Placing & Subscription and the Regent Pacific Subscription (as defined in Plethora's announcements made on 29 August 2014), which is expected to occur on 19 September 2014 and a further announcement will be made by the Company in this respect.

For further details relating to the terms of the License Agreement, shareholders and investors should refer to the section entitled "License Agreement", which appears below within this announcement.

Plethora is continuing negotiations for licensing out PSD502™ with other strategic commercial marketing partners in a number of other territories, including but not limited to, 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, however, shareholders should note that given the nature of licensing negotiations, it is difficult to determine with accuracy the timing of completing such agreements and to give guidance on the terms thereof.

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.

Plethora is also pleased to announce that Recordati and the Company have today entered into a Development, Manufacturing and Supply agreement with Pharmaserve (North West) Limited ("PSNW") for the development, manufacture and supply of PSD502™ for Recordati and Plethora. This agreement supersedes all terms and conditions applicable to the performance of the development services by PSNW in respect of the development proposal entered into between Plethora and PSNW, as announced on 26 March 2014. The agreement is for an initial period of 5 years but will continue thereafter unless terminated. Updates will be made in respect of the anticipated commencement of manufacturing in due course.

Placing & Subscription and Regent Pacific Subscription Update

Further to the Company's announcements made on 29 August 2014, the completion of the Placing & Subscription and the Regent Pacific Subscription are conditional, inter alia, upon Plethora entering into a European licensing agreement with a European partner materially on the terms set out in the Company's circular to shareholders dated 29 August 2014 (such condition now having been satisfied by the License Agreement set out above) and the approval of resolutions at a general meeting of the Company's shareholders. The general meeting is to be held on 18 September 2014 and, subject to the passing of the resolutions at the general meeting, admission to trading on AIM of new shares to be issued pursuant to the Placing & Subscription and the Regent Pacific Subscription is expected to occur on 19 September 2014. Shortly following this, the proceeds of the Placing & Subscription and the Regent Pacific Subscription will be used to make the payments due in respect of the Cessation Agreement and Patent Transfer Agreement.

Jamie Gibson, CEO of Plethora, stated, "We are extremely pleased to have signed this attractive licensing deal with Recordati. We are confident that Recordati's significant experience and marketing reach in men's health and urology will allow it to successfully launch and commercialise PSD502™paving the way for us to potentially receive an attractive flow of milestones and royalties. We are also seeking to generate additional value from PSD502™ via further licensing deals and by working to gain FDA approval for this novel treatment for premature ejaculation in the US."

Giovanni Recordati, Chairman and CEO of Recordati, said "We are very pleased with the addition of PSD502™ to our urology pipeline. This innovative product will reinforce and extend our current franchise in the men's health and urology areas where patients' unsatisfied needs require solutions to improve health and quality of life".

License Agreement

In limited circumstances, if there are material issues in the final development stages of a six dose can, including the submission of a satisfactory feasibility report to Recordati by 31 December 2014, €4m of the Upfront Payment may be refundable to Recordati but only if the License Agreement is terminated by Recordati.

In respect of the Agreed Variations Payment, the grant of variant approval from the European Medicines Agency for a new six dose can is required on or before 30 June 2016, unless agreed otherwise.

The first Milestone Payment of €5 million is due when cumulative net sales of PSD502™ by Recordati or its affiliates exceed €100 million. Further sales based milestones are set for after this, with the full payment of €25 million being due to the Company when cumulative net sales of PSD502™ by Recordati or its affiliates exceed €450 million.

Under the License Agreement, Recordati will assume responsibility for commercialisation activities in the Recordati Territory and will fund all costs associated with the (i) sales and marketing programmes, and (ii) regulatory filings that it intends to pursue.

The License Agreement is for an indefinite period and contains customary provisions in respect of termination. In addition, the License Agreement contains various warranties and indemnities as are customary for such an agreement.

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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