Plethora Solutions Holdings Plc Regulatory News (PLE)

25 July 2011

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Striant® SR commercial update

The Company announces that it has received notification from the Medicines Healthcare Regulatory Agency (MHRA) that the change of ownership of the Marketing Authorisation from Columbia Laboratories Inc to The Urology Company Limited has become effective. Approval for the change of ownership was achieved ahead of the Company's expectations and is the key component of its market expansion throughout the EU.

This represents the Company's first step in the process of achieving broad regulatory approval and commercialisation of Striant® SR across Europe. At present, Striant® SR is approved only in the UK and Italy. The Company intends to achieve broader approval using applications under the Mutual Recognition Procedure (MRP). The MRP provides for a pharmaceutical product to be approved on a fast track by reference to the dossier filed in another member state, in this case the UK.

It is the Company's intention to file applications in an additional four to nine countries, subject to final commercial assessment. It is anticipated that approval by local regulatory agencies will be towards the end of the first half of 2012 with product launch immediately thereafter.

This expansion of Striant® SR into other key markets is important to drive the value of this product. In many countries, testosterone replacement and indeed supplementation is more widely accepted as standard clinical practice than in the UK. The Company has identified a number of potential marketing partners for the product in Europe as approvals are received.

The Company anticipates making further announcements as applications are submitted to the major EU markets later this year and updating timelines for launches.

Ronald Openshaw, CEO, said

"The approval of the change of ownership is an important step which is key to our plan for the successful commercialisation of Striant throughput Europe. Once again this demonstrates our capability in interacting with regulatory authorities which augurs well for future product introductions into key markets."

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About Plethora:

Plethora is focused 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 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

About Striant SR

Striant SR® is a unique formulation of testosterone delivered in a small patch-like tablet which adheres to the buccal mucosa, in a small, natural depression in the mouth where the gum meets the upper lip above the incisor teeth. As it is exposed to saliva, the product softens into a gel-like form, which remains comfortably in place over each 12-hour dosing period. Striant SR® releases testosterone into the blood stream and restores and maintains circulating testosterone at normal levels.