Plethora Solutions Holdings Plc Regulatory News (PLE)

22 November 2013

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Commercial Update

Plethora Solutions Holdings plc (AIM: PLE) provides a commercial update following the announcement on 19 November 2013 of the approval of PSD502, (under the name 'Prilocaine Lidocaine Plethora') by the European Commission.

As part of its disciplined approach to increasing shareholder value, it remains the Company's strategy that PSD502 will be brought to market via partners with the sales, marketing, and distribution infrastructure to maximise the commercial potential from the product.

During 2013, the Company expanded its business development activities by retaining external consultants with expertise in identifying and securing licensing partners and in negotiating these transactions. Since the appointment of these consultants, business development activity has increased significantly. The Company is engaged in dialogue with multiple parties, including major pharmaceutical companies, for a launch of the product, with the initial focus being on the markets within the European Union, the United States (subject to regulatory approval) and other selected territories.

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, however, confident that given the number of parties with which it is talking and the nature of those talks, one or more partners will be secured to lead to a successful commercialisation of PSD 502.

Concurrent with and based on feedback from the licensing activities, the Company is finalising its manufacturing strategy and has identified the lead manufacturer. Plethora will not manufacture the product directly but will either have the product manufactured by a subcontractor or license manufacturing to the marketing partners. In addition, the Company has used this opportunity, at the suggestion of several potential marketing partners, to initiate the development of a canister containing fewer doses. This has been undertaken to develop the marketed product on a cost basis that will maximise the commercial return. The timing of the availability of product will drive eventual launch dates ranging from mid to late 2014.

In addition to the European commercialisation, the Company has significantly advanced its preparation for the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA). The Company believes that the commercial potential in the US is at least as great as that in Europe. Over the coming months, the Company anticipates, as it did with the European filing, to announce progress along various steps with the US approval process.

The Company will provide further commercial updates as matters develop.

Jim Mellon Chairman of Plethora said:

"The European approval is terrific news for the Company and in it delivering shareholder value. The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the Company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales. The Company intends to see the launch of PSD502 at the earliest possible opportunity."

-Ends-

Enquiries:

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 launchPSD502 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.