26 Mar 2014 07:00
26 March 2014
Plethora Solutions Holdings PLC
("Plethora" or the "Company")
Manufacturing Appointment
Plethora Solutions Holdings plc (AIM: PLE) is pleased to announce the appointment of Pharmaserve North West Limited (PSNW) to undertake the manufacturing development leading to the successful introduction of the new 6 dose canister of PSD502 for premature ejaculation. This is a key final step in making product available for the Company's marketing partners that will enable a launch of the product in multiple territories.
Whilst the terms of the agreement with PSNW are governed by confidentiality provisions, the Company estimates that it will spend around £1 million on manufacturing, including the supply of raw materials (prilocaine, lidocaine and other components) and external consultants to the end of 2014.
Subsequent to the assessment of several manufacturing options, PSNW has now been secured as the supply chain and manufacturing development partner for PSD502. PSNW will undertake the work generating data suitable for EU license variation, in conjunction with EUDRAC Ltd, and for inclusion in the initial submission of the New Drug Application (NDA) with the United States Food and Drug Administration (FDA).
PSNW is a leading contract development and manufacturing organisation (CDMO) specialising in the development and manufacture of metered dose inhalers (MDI's), dry powder inhalers (DPI's) and other pharmaceutical aerosols. The dedicated development group, under the guidance of Dr Andrew Brown, have over 20 years experience in developing these dosage forms for both the European and US markets.
Jim Mellon Chairman of Plethora said:
"We welcome Pharmaserve as our manufacturing partner for developing the six dose canister and more importantly providing commercial supplies of PSD502 for the EU market and other territories. This is an extremely important milestone for the Company in its ability to provide commercial supplies to its potential marketing partners in our efforts to commercialise PSD502. In this respect, our efforts continue at pace in securing marketing partners for PSD502."
Dr Padraic O'Brien Managing Director of Pharmaserve Northwest said:
"We are delighted to be partnering Plethora on this program. Relationships such as these support our strategic position as a Leading CDMO in MDI's, DPI's and pharmaceutical aerosols, as well as validating the investment in facilities and the senior management team undertaken over the last few years. We look forward to the successful commercialisation of PSD502."
-Ends-
Enquiries:
Plethora Solutions Jamie Gibson, CEO Mike Wyllie, CSO Mike Collis, CFO | Tel : +44(0) 20 3077 5400 |
Daniel Stewart (Nomad & Joint Broker) David Hart / Ciaran Walsh (Nomad) Martin Lampshire (Broker) | Tel : +44(0) 20 7776 6550
|
Hybridan LLP (Joint Broker) Claire Louise Noyce William Lynne |
Tel: +44(0) 20 7947 4350 Tel: +44(0) 20 7947 4361
|
Britton Financial PR Tim Blackstone | Tel: + 44 (0) 20 7242 9786 +44 (0) 7957 140416 |
About Plethora:
Plethora 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
Plethora is focussed on seeking to launchPSD502 for the treatment of premature ejaculation.
About PSD502 & Premature Ejaculation:
PSD502 is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. The Company anticipates launch in 2014.
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 20 - 30% in men of all ages. There is currently no globally approved and effective pharmaceutical treatment for this condition.
In the absence of any widely approved pharmaceutical therapy with good patient acceptance, 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.