("Plethora" or the "Company")
PSD502 Regulatory Submission UpdatePlethora announces the positive outcomes of Pre-Submission Meetings held with the Rapporteur and Co-Rapporteur (Spain and the UK respectively) for its PSD502 treatment for premature ejaculation.
As part of the approval process Plethora submitted an 88 page Briefing Package to the Rapporteur and Co-Rapporteur. The Briefing Package, which is in essence a summary of the complete dossier, was reviewed by the agencies prior to the meetings and the Company answered questions on its contents during those meetings.
Plethora can report that the Briefing Package was reviewed and all sections, including non clinical, clinical and manufacturing, were found to be entirely consistent with all regulatory requirements for submission of a registration dossier.
Following the Pre-Submission Meetings, Plethora can confirm that the
Company is on track to file the dossier with the EMA in H1 2012. Dr Mike Wyllie, Chief Scientific Officer, said:
"The Pre-Submission Meeting is the first opportunity regulators have had to review information which will be submitted on PSD502 in the full dossier. We are delighted by the response from the two agencies involved in the review and consider this is as a reflection of the quality of our programme.
"We believe PSD502 will be an effective treatment for this area of great unmet medical need which affects at least one in four sexually active men, and that PSD502 will meet the needs of patients and their partners and quickly establish itself as the market leader."
Ronald Openshaw, Chief Executive Officer, said:
"In September last year we executed the Commercialisation Agreement with Shionogi with our shareholders providing the capital to pursue the regulatory filing. We are on target for filing in the first half of this year and look forward to providing further updates in the coming months."
-Ends- Enquiries: Plethora SolutionsRonald Openshaw, CEO
Daniel Stewart (Nomad & Joint Broker)
David Hart / James Felix (Nomad) Martin Lampshire (Broker)
Hybridan LLP (Joint Broker)
Claire Louise Noyce/ Deepak Reddy Newgate Threadneedle
(Financial PR) Guy McDougall/ Graham Herring
Plethora is focussed on the development and marketing of
products for the treatment of urological disorders. The
Company is focussed on: (i) driving the
development of its speciality sales and marketing business,
The Urology Company; and (ii) seeking to increase the value
of its development assets the most advanced of which is
PSD502 for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited,
established in 2009, markets and distributes a range of
pharmaceutical products, pharmaceutical specials, medical
devices and nutritional supplements for the treatment of
urology, sexual health, gynaecology and reproductive health
conditions. Its products fall into two categories (i)
Professional - where a physician, nurse or other healthcare
professional makes a prescribing decision and include
Striant® SR, Urolieve®,
Hyalofemme® and Dianatal®; and (ii)
Consumer - where the consumer/patient makes a buying decision
and include Hyalofemme®,
Multi-Gyn®, Multi-Mam® and
hI-Cran®.
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.ukand www.theurologyco.com
Premature Ejaculation is possibly the most common form of
sexual dysfunction in men. Epidemiological studies conducted
in the US and in Europe indicate a prevalence of
25 to 30% in men of all ages. For example, the American
Medical Association
reported that approximately 20 million men in the US
experience Premature
Ejaculation.
There is currently no globally approved and effective
pharmaceutical treatment for this condition.
In the absence of any approved pharmaceutical therapy, the
Premature Ejaculation market offers significant potential for
development and growth. An effective drug therapy for
Premature Ejaculation may have a comparable commercial
potential to the erectile dysfunction drugs.