16th Feb 2009 11:31
Immediate Release: Monday 16th February 2009
Plethora Solutions Holdings plc
("Plethora" or "the Company")
Sciele Loan Agreement and Conditional Amendment to US License Agreement for PSD502 for Premature Ejaculation
Plethora Solutions Holdings PLC ("Plethora", "The Company", AIM : PLE), the specialist developer of products for the treatment and management of urological disorders, announced today that it has entered into a subordinated loan facility agreement with Sciele Pharma, Inc. ("Sciele"; a Shionogi & Co., Ltd. company), Plethora's licensing partner for PSD502 in the US for the treatment of premature ejaculation. Under the terms of the loan, Sciele has agreed to advance up to £1.65 million to Plethora. The loan will be drawn down in tranches and used specifically for the ongoing PSD502 Phase III development programme. Sciele has already advanced £0.5m of the facility amount to Plethora. The loan tranches will bear interest at 1% above sterling LIBOR.
In addition, the Company has entered into a conditional amendment to the US License Agreement for PSD502 entered into by Plethora and Sciele in May 2007. Under the terms of this amendment, Sciele will make payments totalling $13.7m to Plethora and its debt providers, with the Company receiving a one off royalty payment of $7m, Paul Capital Healthcare receiving $6m and ETV Capital S.A. receiving $0.7m. The amendment is conditional upon a meeting with the FDA scheduled for March 2009 having a satisfactory outcome; meaning that no further development work other than that planned currently will be required to file for approval of PSD502 in the USA. If executed, Sciele will be responsible for all future development and regulatory costs related to the project in the USA and Plethora will not receive any further payments and royalties from Sciele with respect to US rights. If the conditions for the amendment are not satisfied by 1 April then the amended license will not come into effect and the existing license with Sciele will continue.
The loan advanced by Sciele will be repaid on the date that the amended license becomes effective. In the event that the amended license does not become effective the outstanding loan will become repayable on 30 December 2011 provided that Plethora would have a sufficient unrestricted cash balance at that point for the following 12 months. The Sciele loan is unsecured and subordinated to the indebtedness owed to each of Paul Capital and ETV.
Steven Powell, CEO of Plethora, commented:
"This loan and conditional amendment to the Sciele agreement, together with the £1 million placing of convertible loan notes approved by shareholders today, strengthens Plethora's balance sheet both in terms of providing working capital to continue operations and the Phase III development of PSD502. The extension of the Company's cash runway will enable the company to continue to advance its discussions with licensing partners for PSD502 in territories outside of the USA or sale of the asset".
About PSD502:
PSD502 is a patient-friendly proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation.
-Ends-
For further information contact:
|
Plethora Solutions Steven Powell |
Tel : 020 3077 5406 |
|
FinnCap Geoff Nash |
Tel: 020 7600 1658 |
|
Hansard Group Adam Reynolds/John Bick |
Tel: 020 7245 1100 |
About Plethora:
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynaecological pain, erectile dysfunction and premature ejaculation. Plethora has a US subsidiary, Timm Medical Technologies Inc, which markets products for the treatment of erectile dysfunction (ED) to urology clinics through a national US specialty sales team. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:LSE). Further information is available at www.plethorasolutions.co.uk.
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Plethora Solutions Holdings Plc