Plethora Solutions Holdings Plc Regulatory News (PLE)

30 Nov 2009 07:00



30th November 2009

PLETHORA SOLUTIONS HOLDINGS PLC

License and Distribution Agreement

Plethora Solutions Holdings PLC ("Plethora", AIM: PLE), a UK based specialty pharmaceutical company, announces that it has concluded an exclusive UK license and distribution agreement with Happy Child Birth Holding AG ("HCB") to market Dianatal® Obstetric Gel, a unique product developed specifically to reduce the trauma of childbirth via vaginal delivery. Dianatal® Obstetric Gel received European approval for medical use in 2007 and is currently marketed in Switzerland, Germany and a number of other countries. The product is patent protected and is the first obstetric gel licensed for use in humans anywhere in the world. Dianatal® Obstetric Gel will be marketed by Plethora's new subsidiary, The Urology Company Limited, directly to women for use by the medical professional in attendance during vaginal delivery.

Dianatal® Obstetric Gel was developed by Dr. Andreas F. Schaub and leading Swiss Research institutions after analysing the recorded outcomes of deliveries in Switzerland over a ten year period. They noted a strong correlation between the likelihood of trauma during vaginal delivery and vaginal friction forces. Together with Professor Robert Riener of the Swiss Federal Institute of Technology Zurich and Professor Ulrich Bleul of the Vetsuisse Faculty Zurich, HCB then developed a novel sophisticated laboratory model to simulate the effect of vaginal friction on delivery as a means of evaluating gel formulations designed to reduce the physical forces acting on the foetus during birth. This lead to the development of an optimum gel formulation, Dianatal® Obstetric Gel, which was subsequently assessed in a number of controlled clinical studies. In women giving birth for the first time the use of Dianatal® Obstetric Gel reduced the duration of the second stage of labour by up to 30% (equating to a mean reduction of 26 minutes) and significantly decreased the incidence of perineal laceration. The safety of Dianatal® Obstetric Gel has been rigorously established and there is no evidence of irritation or other unwanted effects on either mother or newborn child.

Steven Powell, CEO of Plethora, commented: "We are delighted to be able to offer women in the UK the opportunity to benefit from this product which has been proven to significantly reduce the duration and trauma of labour during first-time deliveries". 

Dr Andreas Schaub (Consultant Obstetrician, Founder and CEO of HCB), said: "Our clinical experience and patient feedback confirms that the Dianatal® Obstetric Gel will make a positive contribution to the experience and outcome of childbirth and reduce clinical costs associated with childbirth."

-Ends-

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 HCB Happy Child Birth Holding AG:

HCB was founded in 2003 by Dr. Andreas Schaub and senior pharmaceutical executives to commercialise products to ease the trauma of childbirth in mothers and newborns and to optimise birth outcomes in mothers and newborns. The Company is headquartered in Switzerland.

Further information can be found at www.happychildbirth.com and www.dianatal.com