28th Sep 2011 07:00
28 September 2011
Plethora Solutions Holdings plc
("Plethora" or "the Company")
Amendment to PSD502 Agreements
Plethora announces that it has today entered into an amendment to its 2009 licensing agreement with Shionogi Pharma, Inc. ("Shionogi") under which Plethora will assume control of the registration and commercialisation of PSD502 in Europe and a number of other territories in the Rest of the World (the "Amendment"). PSD502 is a treatment for premature ejaculation developed by Plethora through successful phase III clinical trials.
Plethora and Shionogi entered into two licensing agreements in 2009 firstly for the United States and secondly for the Rest of the World. Over the course of the last two years, Plethora has developed a commercial infrastructure in the United Kingdom and is planning to expand this into Europe via distribution arrangements. Shionogi and Plethora have agreed that due to this developing strength and strategic focus, it is appropriate for Plethora to undertake registration and commercialization of PSD502 in Europe and certain other territories. Both companies will collaborate to share information to their mutual benefit as they proceed in their respective territories.
The Amendment provides that Plethora will undertake the regulatory filing and business development activities for PSD502 in a number of territories including Europe and the Rest of the World but excluding the United States, North America, South America Japan, Korea, China and Taiwan. Under the Amendment, Plethora will fund the costs of commercialisation but will receive a majority share of the income arising from PSD502 in the relevant territories. In respect of North America (excluding the United States), South America, Korea, China and Taiwan these geographies remain covered by the existing 2009 agreement, with Plethora earning a share of upfront and milestone income earned by Shionogi and a royalty on product sales. In relation to the United States and Japan Plethora will not earn any further income from PSD502.
It is Plethora's intention to file PSD502 for registration in Europe at the earliest practical opportunity and to seek approval in line with normal timescales. Work has already commenced to meet this objective. In addition, Plethora will seek to partner PSD502 with larger pharmaceutical companies with the marketing strength and product support to achieve the product's full potential. In order to fund this activity, the Company has in a separate press release today announced a financing to provide the funds the Company will require to achieve European registration.
Ronald Openshaw, Chief Executive, Plethora said:
"Premature ejaculation is a serious problem for many men and we believe that the market for a clinically proven and effective product remains unsatisfied. PSD502 has successfully completed multiple pivotal clinical trials and represents an important potential treatment to fill the unmet clinical needs of patients.
We believe that the value of this product is substantial. We are grateful for Shionogi's support and the agreement reached today protects and enhances our position enables us to deliver this value for both companies."
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Enquiries:
Plethora Solutions Ronald Openshaw | Tel : +44(0) 20 3077 5400 |
Daniel Stewart (Nomad & Joint Broker) Paul Shackleton / David Hart (Nomad) Martin Lampshire (Broker) | Tel : +44(0) 20 7776 6550
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Hybridan LLP (Joint Broker) Claire Louise Noyce | Tel: +44(0) 20 7947 4350
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Hansard Communications Nicholas Nelson/Guy McDougall | Tel: +44(0) 20 7245 1100
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About Plethora:
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company isfocussed 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 assetsthe most advanced of which is PSD502 being developed for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into to 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.uk and www.theurologyco.com
Related Shares:
Plethora Solutions Holdings Plc