Plethora Solutions Holdings Plc Regulatory News (PLE)

 3 December 2010

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Product Update

Clinical data & new supply and distribution agreement

Plethora Solutions Holdings plc (AIM: PLE), the UK-based speciality pharmaceutical company, announces new clinical data confirming the effectiveness of Hyalofemme™ and a supply and distribution agreement with a national UK pharmacy retail chain.

Hyalofemme™ is a treatment for vaginal dryness arising from atrophic vaginitis. The product is marketed and distributed in the UK by Plethora's subsidiary, The Urology Company Limited. Vaginal dryness is a common condition and is suffered by over a third of women during the menopause. It can also occur post childbirth and may arise as a result of the treatment of breast and ovarian cancers.

New Clinical Data

The benefit of Hyalofemme™ in the treatment of vaginal dryness has been confirmed in a recent multicentre clinical study. The randomised study enrolled 144 women of menopausal age (mean age 54 years) with vaginal symptoms and compared Hyalofemme™ treatment to treatment with an oestrogen-containing vaginal cream. Symptoms were recorded prior to treatment and on completion of the 30 day treatment period. Subjects applied either Hyalofemme™ or oestrogen cream once every 3 days.

Both treatments resulted in a similar improvement in vaginal dryness at the end of the treatment period. Improvement rates of 84.4% for Hyalofemme™ and 89.4% for the oestrogen cream were observed with no statistically-significant difference between the two arms. Further, comparable rates of improvement were recorded in other vaginal symptoms including, itching, dyspareunia and burning sensation. No significant difference in treatment-related changes in the vaginal environment (pH and microbiology) was indicated.

The investigators concluded that treatment with Hyalofemme™ was non-inferior to treatment with oestrogen cream with regard to improvement in vaginal symptoms particularly vaginal dryness. They also concluded that Hyalofemme™ promotes the repair of friction-induced lesions arising from dryness of the vaginal mucosa. The study also reported that there were no serious adverse events arising from the use of Hyalofemme™ .

The results confirm the clinical efficacy of Hyalofemme™ and demonstrates that it is a viable alternative to hormone treatment for the relief of menopause-associated vaginal symptoms with an enhanced safety profile. Also, unlike some of the hormone based alternatives, it is not contraindicated for underlying medical conditions or the possibility of interaction with other medications.

Retail supply & distribution agreement

Plethora also announces that it has signed a supply and distribution agreement for Hyalofemme™with a leading UK pharmacy retail chain. The retailer will launch the product as an own label product and Plethora anticipates that the product will be available to customers nationwide from the beginning of 2011.

Dr Steven Powell, Chief Executive Officer, Plethora said:

"This new clinical study demonstrates that Hyalofemme™ can produce rapid and effective reversal of vaginal dryness and it therefore provides an effective viable alternative to hormone based treatments.

"The retail distribution agreement will ensure that the product is readily available nationwide."

-Ends-

Enquiries:

Notes to Editors:

Hyalofemme™ is a proprietary gel formulation of hyaluronate, a naturally occurring polysaccharide with moisturising and lubricating properties, which has been designed for the relief of vaginal dryness. Hyalofemme™ is a registered trademark of Fidia Farmaceutici SpA. Plethora holds the UK exclusive distribution rights for Hyalofemme™.

Vaginal dryness is caused by vaginal atrophy, or atrophic vaginitis. This is common condition is experienced by almost a third of women and can arise from the hormonal changes that occur after childbirth, before and after the onset of menopause or as a result of the treatment of breast and ovarian cancers.

Normal vaginal tissue is soft and elastic with the vaginal epithelium maintaining an appropriate level of hydration and lubrication. In certain situations which lead to decreased oestrogen (particularly during the menopause) an imbalance arises leading to decreased lubrication which can result in dryness, vaginal burning and itching and painful intercourse ("dyspareunia"). These symptoms are experienced by almost a third of women early in menopause and become more common later in the post menopause period. Restoration of normal hydration and lubrication can be of considerable potential benefit to sufferers. This can be achieved by oral hormone replacement therapy, local application of hormonal preparations (oestrogen containing creams) or by hydrating gels now. 

Further information on products available through The Urology Company can be found at www.theurologyco.com

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