Plethora Solutions Holdings Plc Regulatory News (PLE)

3 February 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Company update and Investor presentation

Plethora (AIM: PLE) is pleased to provide shareholders with an update on recent developments.

Following grant of the market authorisation from the European Medicines Agency (EMA) for its treatment for Premature Ejaculation ("PSD 502") in November 2013, the Company has sought legal advice from its external lawyers pertaining to data and market exclusivity rights in the EU which prevent third parties from relying on Plethora's regulatory dossier if they seek regulatory approval of their products. Consequently, the Company is pleased to inform shareholders that it has been advised that data and market exclusivity rights arise automatically and are owned by Plethora without the need for any further application, examination or certification, and the Company believes that data exclusivity should apply until November 2021 and market exclusivity until November 2023. On that basis, no abridged application by a third party for approval of its product, based on Plethora's regulatory dossier, can be made until data exclusivity expires in November 2021 and no marketing authorisation of a third party's product can be obtained using an abridged application until November 2023.

There is European patent coverage in 17 EU countries (including the UK, Germany, France, Spain and Italy) until March 2016. In addition, following grant of the EMA market authorisation for PSD 502 in November 2013, applications for Supplementary Protection Certificates ("SPCs") are being filed in the EU countries where there is patent protection. SPCs provide an extra monopoly period after the patent would ordinarily expire, to compensate for time lost obtaining regulatory approval for a product. If SPCs are granted, they will provide 5 more years of protection in each EU country where granted, i.e. until March 2021.

The Company's discussions with a number of potential multi-national licensing partners have reached a more advanced stage and the directors are encouraged with progress so far. However, 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 also in detailed discussions with its preferred manufacturing partner.

Following these discussions, and in light of feedback from a leading US consultancy in respect of the US pricing landscape for PSD 502, the Company is considering reducing the dosage per canister used for the product, moving to a six dose canister from the current 20 dose canister that was used in obtaining EMA approval. The US pricing analysis also concluded that PSD 502 should be priced similar to other erectile dysfunction ("ED") agents at around US$100 per 6 dose can (or US$16 per dose), though the Company expects more varied pricing across EU member countries. By way of benchmark, at equivalent pricing, we understand that the leading ED products have generated revenues in excess of £2 billion per annum. Plethora is working with its consultants and manufacturing partners to establish the appropriate timeline to enable a six dose canister to be launched, including the necessary EMA amendment approvals.

PSD 502 in the US

The Company is continuing its preparations for a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA"). In September 2013, the Company appointed US regulatory consultants to act on the Company's behalf. Earlier this month, the Company and its consultants had an initial guidance meeting with the FDA to discuss the proposed NDA. Based on this positive interaction, the Company now expects to make a submission to the FDA by the first quarter of 2015. This submission will be based on the EU dossier prepared historically by the Company but incorporating a new can size (six doses, three sprays per dose). Based on the recent market sensitivity analysis and interactions with potential licensing partners, Plethora believes that incorporation of this new can size in the dossier will dramatically increase the commercial value of the product to an extent equivalent to that achieved by the leading drugs for ED. The Company currently estimates that, if successful, PSD502 could achieve FDA approval in the first quarter of 2016 with product launch shortly thereafter.

On FDA approval of PSD 502 in the US, a period of regulatory exclusivity to protect Plethora's data is expected to run for at least 3 years from the date of FDA approval, though it could be 5 years if the FDA treats PSD 502 as a new chemical entity. Generic versions of PSD 502 wishing to cross refer to Plethora's US regulatory data, in an abridged new drug application, could not apply until 1 year before the regulatory exclusivity period expires and could not receive approval until the period expires. Another substantial barrier to entry for a generic is the time and cost of undertaking a Phase III study, which we estimate at being 3 years for completion of such study and at an estimated cost of US$12 million to US$18 million.

There is US patent coverage that runs to March 2015 but, if FDA approval of PSD 502 is obtained, a patent term extension ("PTE") may be available. PTEs provide an extra period of up to 5 years after the US patent would ordinarily expire, to compensate for time lost obtaining regulatory approval of the product.

In addition the ongoing development of the new manufacturing process could well generate new IP coverage.

Investor presentations

Plethora also announces that Jamie Gibson and Mike Wylie, both members of the management team, will be undertaking a series of investor presentations over the coming days.

Accordingly, Plethora has uploaded a presentation onto the Company's website which is now available to view at www.plethorasolutions.co.uk.

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.