Plethora Solutions Holdings Plc Regulatory News (PLE)

19 December 2011

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Product Update PSD502

Appointment of Rapporteur & Co-Rapporteur - regulatory filing on track

The Company announces that, following a submission to the European Medicines Agency (the "EMA"), the EMA has appointed the pharmaceutical regulatory agencies of Spain as Rapporteur and the United Kingdom as Co-Rapporteur to review the planned dossier for the approval of PSD502, Plethora's proprietary new drug for the treatment of premature ejaculation.

In September 2011, the Company announced that it had secured operational control of PSD502 in Europe and certain other territories in the rest of the world. Further, the Company set out that its objective was to prepare a regulatory submission for the filing and approval of PSD502 in Europe. Plethora intends to file for approval on a Centralised basis which, when approved, would permit the marketing of PSD502 in all EU member states and certain Asian countries.

The appointment of the Rapporteur and Co-Rapporteur is the first step in the filing of the regulatory submission. It is the Rapporteur and Co-Rapporteur which will review the regulatory dossier and subsequent submissions and then provide recommendations to the EMA and member states for the approval of new pharmaceuticals.

Plethora has now engaged in a dialogue with these regulatory agencies prior to an intended submission of a dossier in 2012.

Ronald Openshaw, Chief Executive, Plethora said:

 "In September 2011, we agreed to take control of PSD502 and we raised money from investors partially to fund our regulatory development. I am pleased to report that this project is on schedule to meet the objectives we set ourselves at that time. Alongside this, we have commenced the process of seeking a partner to assist Plethora in the commercialisation of this important new product in our territories."

Mike Wyllie, Chief Scientific Officer, Plethora said:

"The appointment of the Rapporteur and Co-Rapporteur is a key step in the registration of PSD502 and we are looking forward to continuing to work with the Spanish and UK agencies. Work on the preparation of the full dossier has commenced in earnest and we expect to submit the dossier on schedule next year. We believe there is no product on the market which meets patients' needs and consider that PSD502 represents an important treatment for men suffering from premature ejaculation."

-Ends-

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About Plethora:

Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company is focussed on: (i) driving the development of its speciality sales and marketing business, The Urology Company; and (ii) seeking to increase the value of its development assetsthe most advanced of which is PSD502 for the treatment of premature ejaculation.

Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into two categories (i) Professional - where a physician, nurse or other healthcare professional makes a prescribing decision and include Striant® SR, Urolieve®, Hyalofemme® and Dianatal®; and (ii) Consumer - where the consumer/patient makes a buying decision and include Hyalofemme®, Multi-Gyn®, Multi-Mam® and hI-Cran®.

The Company 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 and www.theurologyco.com