Plethora Solutions Holdings Plc Regulatory News (PLE)

20 September 2013

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Positive CHMP Opinion

for PSD502 a treatment for premature ejaculation

Plethora Solutions Holdings plc (AIM: PLE) announces that it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission (EC) approval for PSD502 (known in the Marketing Authorisation Application as "Lidocaine Prilocaine Plethora") for the treatment of primary premature ejaculation in adult men.

A CHMP positive opinion is one of the final steps before Marketing Authorisation is granted by the European Commission. The CHMP's positive recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Plethora anticipates a final decision from the EC shortly, as this usually occurs approximately 60 days after a CHMP recommendation. Plethora anticipates that when approved by the EC PSD502 will be launched in Europe as soon as practicable thereafter.

PSD502 is a treatment for premature ejaculation, comprising a combination of lidocaine and prilocaine in a spray formulation. Clinical studies have demonstrated that PSD502 is effective in treating premature ejaculation with an acceptable safety profile.

Ronald Openshaw, CEO Plethora said:

"Today's announcement by the CHMP is the key opinion the Company has been seeking to obtain European approval. We are delighted by today's news after such a significant period to reach this milestone.

Premature ejaculation is a highly distressing condition for patients and their partners and there remains a significant unmet medical need given the lack of effective products to treat it.

Our efforts are now focussed on achieving a European launch post EC approval and on the US filing with the FDA. The Company's goal is to see PSD502 available internationally to improve the lives of so many couples."

-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 product has completed all clinical testing.

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.