Plethora Solutions Holdings Plc Regulatory News (PLE)

15 March 2012

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

PSD502 Regulatory Submission Update

Plethora announces the positive outcomes of Pre-Submission Meetings held with the Rapporteur and Co-Rapporteur (Spain and the UK respectively) for its PSD502 treatment for premature ejaculation.

As part of the approval process Plethora submitted an 88 page Briefing Package to the Rapporteur and Co-Rapporteur. The Briefing Package, which is in essence a summary of the complete dossier, was reviewed by the agencies prior to the meetings and the Company answered questions on its contents during those meetings.

Plethora can report that the Briefing Package was reviewed and all sections, including non clinical, clinical and manufacturing, were found to be entirely consistent with all regulatory requirements for submission of a registration dossier.

Following the Pre-Submission Meetings, Plethora can confirm that the Company is on track to file the dossier with the EMA in H1 2012.

Dr Mike Wyllie, Chief Scientific Officer, said:

"The Pre-Submission Meeting is the first opportunity regulators have had to review information which will be submitted on PSD502 in the full dossier. We are delighted by the response from the two agencies involved in the review and consider this is as a reflection of the quality of our programme.

"We believe PSD502 will be an effective treatment for this area of great unmet medical need which affects at least one in four sexually active men, and that PSD502 will meet the needs of patients and their partners and quickly establish itself as the market leader."

Ronald Openshaw, Chief Executive Officer, said:

"In September last year we executed the Commercialisation Agreement with Shionogi with our shareholders providing the capital to pursue the regulatory filing. We are on target for filing in the first half of this year and look forward to providing further updates in the coming months."

-Ends-

Enquiries:

About Plethora:

Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company isfocussed 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 pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, sexual health, gynaecology and reproductive health 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

About Premature Ejaculation:

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 25 to 30% in men of all ages. For example, the American Medical Association reported that approximately 20 million men in the US experience Premature Ejaculation. 

There is currently no globally approved and effective pharmaceutical treatment for this condition.

In the absence of any approved pharmaceutical therapy, 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.