Plethora Solutions Holdings Plc Regulatory News (PLE)

23 Nov 2009 07:00



23rd November 2009

PLETHORA SOLUTIONS AND COLUMBIA LABORATORIES EXECUTE EXCLUSIVE MARKETING AGREEMENT FOR STRIANT SR®

London, UK and Livingston, NJ - November 23, 2009 - Plethora Solutions Holdings PLC ("Plethora", AIM: PLE) and Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today that they have executed an exclusive license and distribution agreement whereby Plethora will market Columbia's Striant SR® 30 mg mucoadhesive buccal tablets for testosterone replacement therapy in men with hypogonadism in the UK. The product received UK marketing approval from the Medicines and Healthcare Regulatory Authority in 2004. 

Declining testosterone levels ("late onset" hypogonadism) are a natural consequence of aging. Epidemiological studies suggest that over one third of men aged 45 years or more visiting primary care practices have low testosterone levels and of the eight million men aged between 45 and 65 living in the UK, it is estimated that over 2.5 million have lower than normal testosterone levels and might benefit from testosterone replacement therapy. In some men, low testosterone causes fatigue, lethargy, loss of libido and erectile dysfunction and in the longer term, a higher risk of osteoporosis and bone fracture. Low testosterone is more common in men with Type 2 diabetes and is associated with visceral obesity and insulin resistance. The importance of evaluating testosterone levels in symptomatic men and the use of testosterone replacement therapy is recognised by leading authorities including the International Society of Andrology and the European Association of Urology. 

Striant SR® is a unique formulation of native testosterone delivered in a small patch-like tablet which adheres to the buccal mucosa, the 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. The product will be marketed by Plethora's newly formed subsidiary, The Urology Company Limited.

Steven Powell, Chief Executive Officer of Plethora, commented, "The benefits of testosterone replacement therapy are recognised by urologists and andrologists as an effective means of restoring full sexual function and increasingly as a means of better controlling obesity and other symptoms common in men with diabetes and other metabolic conditions. A number of testosterone products are available in the UK, such as gels and patches, but we believe that Striant™ SR offers patients a convenient alternative." 

Columbia Laboratories' Chief Executive Officer Robert S. Mills stated, "We are pleased that Striant SR® will be available to medical practitioners in the UK and that their male patients will benefit from its convenience and ability to rapidly restore normal levels of testosterone."

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Enquiries:

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), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE) 

Further information is available at www.plethorasolutions.co.uk

About Columbia:

Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and marketing products for the reproductive healthcare and endocrinology markets using its novel bioadhesive drug delivery technology. Further information is available at www.columbialabs.com.