Plethora Solutions Holdings Plc Regulatory News (PLE)

Plethora Solutions Holdings PLC ("Plethora")

Global expansion of commercialisation of PSD502 - a treatment for premature ejaculation

Plethora announces that it has agreed with Shionogi Inc. ("Shionogi") to expand globally the scope for Plethora to pursue the regulatory approval and commercialisation of PSD502, a drug being developed to treat premature ejaculation. Plethora will now take responsibility for all aspects relating to the global development, registration and commercialisation of PSD502.

Shionogi and Plethora have had a relationship relating to PSD502 since 2007, initially through Sciele Pharma Inc. In 2011, Shionogi granted to Plethora the rights for the regulatory and commercial development of PSD502 in Europe and certain other territories.

Since 2011, Plethora has sought regulatory approval of PSD502 in Europe, filing a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA"). Plethora anticipates an approval decision before the end of 2013 by the EMA.

Under the new agreement Plethora will now assume responsibility for the regulatory and commercial development of the product throughout the world, including in territories previously excluded, specifically North America, South America, Japan, Korea, Taiwan and China. Plethora will, at its own cost, file a New Drug Application ("NDA") with the Food and Drug Administration ("FDA"). Plethora intends to submit such an application not later than the end of the first half of 2014. Based on historical timescales, assuming approval, PSD502 could be launched in the United States in the second half of 2015. Plethora will modify the European dossier as a basis for the NDA. The parties have agreed that they will share the income arising from these additional territories in a fixed proportion, with Plethora earning the majority proportion. Further details are confidential and are not disclosed.

Plethora estimates that there are in excess of 97 million men in the US between the ages of 20 and 69 years old. Epidemiological studies conducted in the US and Europe indicate that between 20-30% of men of all ages suffer from premature ejaculation. Based on an assumption of 1-in-4 men with the condition, the potential patient group could be in excess of 24 million men in the US. Consequently, Plethora believes that, even based on achieving modest market share, the US market could be several hundreds of millions of dollars per annum.

Plethora will seek such additional partners as are necessary to ensure the launch of the product in high-potential territories around the world.

Ronald Openshaw, CEO, Plethora Solutions Holdings PLC said:

"Today's agreement marks an important step in the global commercialisation of PSD502. Premature ejaculation is probably the most prevalent male sexual dysfunction, with an estimated 1-in-4 men suffering from this condition. We anticipate the European Approval this year and intend immediately to initiate the regulatory and commercial development in the United States."

Dr John Keller, CEO, Shionogi Inc said:

"Plethora has made considerable progress in their prosecution of the European Marketing Authorisation Application for PSD502 and their business development activities. Given their focus and dedication to achieving the maximum possible potential for PSD502, we are pleased that they will undertake the primary responsibility to successfully register and, with partners as appropriate, commercialise this important potential treatment in territories around the world. "

-Ends-

Enquiries:

About PSD502 & Premature Ejaculation:

PSD502 is a topical spray being developed for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. The product has completed all clinical testing in Europe and has been submitted for approval in Europe with the EMA. If approved, the Company anticipates launch in early 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 prescription pharmaceutical treatment for this condition.

In the absence of any widely approved prescription pharmaceutical therapy with good patient acceptance, the Company believes that the premature ejaculation market offers significant potential for development and growth. An effective prescription drug therapy for premature ejaculation may have a comparable commercial potential to the erectile dysfunction drugs.

About Plethora:

Plethora is focussed on the development and marketing of products for the treatment of urological disorders, particularly PSD502 for the treatment of premature ejaculation. 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 

Forward Looking Statement

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward- looking statements whether as a result of new information, future events or otherwise.