Sciele Pharma, Inc. and Plethora Solutions Holding plc (Plethora) have signed an exclusive license agreement for the marketing of PSD502 for premature ejaculation (PE) in the United States together with an agreement for Sciele to purchase a $7 million equity stake in Plethora.

Plethora is developing innovative products for women's health and male sexual dysfunction. Plethora has products in clinical development for the treatment of premature ejaculation, overactive bladder, stress urinary incontinence, interstitial cystitis and gynaecological pain.

Under the terms of the license agreement, Plethora will receive payments upon achievement of regulatory and sales milestones, and royalty payments on product sales. Plethora will have co-promotion rights for urologists in the United States.

PE is the most common form of sexual dysfunction among men. PE is estimated to affect approximately 25% to 30% of men of all ages (Laumann et al 1999 JAMA 281 537-44). According to the results of this survey, approximately 25 million men between the ages of 18 and 59 in the US experience PE.

PSD502 comprises a unique, proprietary, and rapidly absorbed formulation of two well-established local anaesthetics, lidocaine and prilocaine, dispensed in a metered dose spray. Plethora has completed a phase II clinical trial using PSD502, and Plethora is expected to begin a phase III study in the second half of 2007.

Under the agreement to purchase a $7 million equity stake in Plethora, Sciele has purchased 1,772,505 new Ordinary Shares in Plethora at GBP 2.00 per share.

Patrick Fourteau, chief executive officer of Sciele, said, "We are pleased to take an equity stake and enter into this collaboration with Plethora as they are developing new products for Women's Health and sexual dysfunction. This partnership will enable us to further expand our product pipeline and leverage our sales force. We are enthusiastic about PSD502, which may provide a potential PE treatment, addressing an unmet medical need for millions of men."

Steven Powell, chief executive officer of Plethora, said, "We are delighted to have Sciele as a licensing partner and welcome them as a shareholder. We look forward to working with Sciele and to updating our shareholders on progress with licensing PSD502 for premature ejaculation elsewhere in territories outside the USA."