Plethora Solutions – PSD502 Regulatory Submission Update

11 June 2012

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

PSD502 Regulatory Submission Update

Plethora announces that it has submitted a dossier to the European Medicines Agency ("EMA") for the approval of PSD502 as a new medicine to treat premature ejaculation ("PE"). The Company is seeking approval of PSD502 through the centralised procedure, which if and when granted would provide the ability to sell the product across all 27 member states. Based on normal timelines the Company anticipates that approval should occur 12-18 months following submission.

PSD502 is a topical spray containing two local anaesthetics, prilocaine and lidocaine. The product completed two phase III pivotal trials in 2009 and has been tested on over 600 patients with a total of approximately 26,000 doses delivered. The Company believes that the clinical studies conducted to date demonstrate that PSD502 is safe and highly effective in treating PE.

The International Society of Sexual Medicine ("ISSM") defined PE as a male sexual dysfunction characterised by: ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy.

The incidence of PE has been studied and reported in peer reviewed academic journals on multiple occasions. While estimates vary, PE is reported to affect approximately 20-30% of sexually active men. Data shows that the incidence of PE is consistent across all age, socio-economic, geographic and ethnic groups. The Company estimates that the incidence of PE in the general population is potentially larger than the incidence of erectile dysfunction.

In the 27 member states of the European Union, the Company estimates that there are in excess of 150 million men aged between 20-69 years old. With the estimated incidence of PE this implies that the potential population of men in the EU with the disorder is approximately 30-45 million. A centralised approval of PSD502 by the EMA would permit the product to be marketed to this entire group.

As with erectile dysfunction 15 years ago before the introduction of Pfizer (BSE: PFIZERSL.BO - news) 's Viagra, premature ejaculation is not widely treated. The Company believes this is because of an absence of a generally available safe, effective and approved pharmaceutical treatment. The Company believes there is a significant unmet medical need in the treatment of PE. At present only one product, Priligy, is approved, in only a limited number of countries. In a post launch study it was shown that up to 90% of patients discontinued use of this product. This was due to a lack of clinical effect, restrictive side effects and/or cost.

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Plethora Solutions - PSD502 Regulatory Submission Update