Plethora Solutions Holdings Plc Regulatory News (PLE)

14 March 2011

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Acquisition of European rights to Striant® SR

Plethora, the urology and sexual health focussed speciality pharmaceuticals company, announces that it has secured exclusive pan European rights to Striant® SR from Columbia Laboratories, Inc. ("Columbia").

On 17 November 2010, Plethora announced the UK launch of Striant® SR aimed at the male sexual health market having been granted UK rights to the product in December 2009. The product is marketed by Plethora's marketing and distribution subsidiary, The Urology Company, under license from Columbia. Under today's agreement The Urology Company will have broader European rights to the product and become the Marketing Authorisation holder in the UK giving Plethora full control over the product in Europe and will apply for marketing approval across Europe in its own name. The agreement provides for the assignment of the Striant® SR trademarks and a licence to the patents primarily in the countries of the EU.

Under the terms of the agreement, The Urology Company will pay Columbia a royalty on Striant® SR revenue where it sells the product directly and a share of profits in those territories where the product is distributed by third parties.

Striant® SR & Testosterone replacement

The UK market for testosterone replacement was approximately £13 million in 2010 and has been growing at 14% p.a. Despite this significant expenditure, the use of testosterone replacement therapy is in its infancy in the UK. For example, the USA market for testosterone usage is in excess of $900 million per annum usage is therefore at approximately 8 times greater on a per capita basis.

The Company believes that Striant® SR has clear advantages over other testosterone drug preparations. These advantages include a greater consistency of blood levels of testosterone within the "normal" range, lower inter-patient variability, easier application, reduced mess and odour and reduced risks of partner transfer associated with gels.

European Launch

Market authorisation for Striant® SR within the EU will be sought through the Mutual Recognition Process whereby other member states grant authorisation based on an initial approval in a reference state, in this case the UK. The Company anticipates that the approval process will be largely complete by the end of 2011 and product launches in other member states will take place either late 2011 or early 2012.

It is Plethora's intention that The Urology Company will focus on marketing Striant® in the UK through its own sales force. In Continental Europe, the Company intends to enter into local distribution agreements and initial discussions have commenced with potential partners. It is hoped that these partnerships will also provide the basis for The Urology Company to distribute further products into a widened geographical area.

Bill Robinson, Chairman, commented:

"We are pleased to secure the rights to Striant® SR for the European market. Since the launch of Striant® SR late last year physician feedback has been positive and sales are beginning to climb. We believe the European market has the potential for significant growth in testosterone replacement and that Striant® SR has clear advantages over existing therapies. Securing the European launch is important for the broader long term development of the Company as a whole."

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NOTES FOR EDITORS

Striant® SR & Testosterone replacement

Striant® SR is a testosterone replacement treatment for use in men with reduced testosterone levels. Striant® SR is a soft gel tablet which adheres to the gum (buccal delivery) and delivers the drug across the tissue membrane, buccal mucosa. The results from use are highly effective giving rise to normal testosterone levels in 24 hours whilst delivering consistent results across diverse patient groups, both intra-patient and between individual patients.

Testosterone levels naturally decline with age -"late onset hypogonadism" - and can be associated with loss of libido, erectile dysfunction, mood changes, a reduction in muscle mass, changes to the skin and hair and sleep disturbances. Low testosterone has also been linked with increased body mass index, waist circumference and poor blood sugar control in type 2 diabetes, with a consequent increased risk of cardiovascular problems.

Around 40% of men aged 40 or over experience some form of erectile dysfunction and of these, over 30% will have low testosterone levels. While there are a number of oral drugs to treat erectile dysfunction, not all individuals experience a satisfactory improvement in sexual function and may benefit from testosterone supplementation.

About Plethora:

Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder (PSD506), stress urinary incontinence (PSD503 - Virgafem), interstitial cystitis (PSD597 - Urolieve) erectile dysfunction (PSD510) and premature ejaculation (PSD502). Plethora's subsidiary, The Urology Company Limited, was established in 2009 to market and distribute a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions.

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 Columbia Laboratories, Inc.

Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company's strategy is to fund new development projects through proof of concept, then partner for later-stage clinical development and commercialization. CRINONE® 8% (progesterone gel) is marketed by Watson Pharmaceuticals in the United States and by Merck Serono in foreign countries.

Columbia's press releases and other company information are available online at www.columbialabs.com.