Plethora Solutions Holdings Plc Regulatory News (PLE)

 15 April 2011

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Hyalofemme® Product Update

NHS approves Hyalofemme® for reimbursement

Plethora Solutions Holdings plc (AIM: PLE), the UK-based speciality pharmaceutical company, announces that its subsidiary, The Urology Company Limited has received notification that Hyalofemme®, a treatment for vaginal dryness, has been granted approval by the UK NHS Business Services Authority for reimbursement under an NHS prescription. This allows, for the first time, a doctor in the UK to write an NHS prescription for Hyalofemme® to treat patients suffering from atrophic vaginitis.

Atrophic vaginitis, also referred to as vaginal dryness or vaginal atrophy, is a common, distressing and painful condition affecting as many as 6 million women in the UK. It is suffered by up to half 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.

This condition is most often treated using hormonal creams containing estrogen. However, many physicians and/or their patients either wish to avoid the use of hormonal preparations or find that, particularly with cancer patients, their use is not permitted or is contra-indicated. Lubricants can also be used but tend to deliver only short term relief. Hyalofemme®, however, has been shown to be effective when used 3 times per week in reducing the symptoms of atrophic vaginitis and is well accepted by patients.

As announced by the Company in December 2010, in an international study, Hyalofemme® was found to be as effective as a leading hormonal preparation. This information was submitted to the NHS Business Services Authority in determining the approval.

Hyalofemme® is marketed and distributed exclusively in the UK by Plethora's subsidiary, The Urology Company Limited.

Bill Robinson, Chairman, Plethora said:

"Today's news follows the agreement with a leading retail pharmacy to carry an own label version of this product in December. We believe that Hyalofemme® will be an important treatment for atrophic vaginitis and the NHS's decision should enable the large numbers of patients to access this effective remedy. This decision should increase the commercial value of our pipeline by exploiting products secured last year."

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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