NAPA, Calif., July 9 /PRNewswire-FirstCall/ -- Senetek PLC , a specialty dermatology and skincare company targeting the science of aging, today reported that Plethora Solutions Holdings PLC (AIM: PLE), Senetek’s exclusive licensee for its patented erectile dysfunction drug Invicorp(R) in North America, announced on July 2, 2007 that it has secured funding for completion of clinical development and the FDA approval process for Invicorp as detailed in the following press release:
Product Update - Invicorp(R) (PSD510) for erectile dysfunction -- 4m pounds Sterling new funding to complete development and approval -- Final product registration studies to start before year end -- Product launch anticipated in 2009
Plethora Solutions Holdings PLC (“Plethora”, AIM: PLE), the developer of specialist products and therapeutics for the treatment and management of urological disorders, today announces that it has secured 4 million pounds in a secured loan from ETV Capital S.A. (“ETV”). This additional funding will allow Plethora to complete the clinical development and filing for US market approval of Invicorp(R), a potential treatment for erectile dysfunction (ED). Plethora licensed the exclusive North American rights to Invicorp(R) from Senetek PLC in February 2006.
In February 2007, Plethora announced its intention to initiate the Phase III trial for Invicorp(R) and recent meetings with the FDA have confirmed the path to submission of the NDA for Invicorp(R) as a front-line therapy for erectile dysfunction (ED):
-- The final product registration studies will be initiated before year end and will be completed within 15 months. -- Product launch in the US is anticipated by the end of 2009.
In line with its commitment to manage its product portfolio to focus on revenue growth that will lead to profitability, the launch and commercial development of Invicorp(R) will be undertaken by Plethora’s own urology- focused sales and marketing operation in the USA, Timm Medical. The anticipated launch of Invicorp(R), together with the retention of US co- promotion rights for PSD502 for premature ejaculation (PE) in its recently announced licensing agreement with Sciele Pharma Inc., are key components in Plethora’s strategy to further leverage Timm Medical’s dedicated sales and marketing infrastructure to market speciality therapeutics to urologists. Plethora expects the Timm Medical sales force to be marketing first line therapies for both ED and PE, in addition to its current, profitable range of medical devices, by the end of 2009.
Invicorp(R) is administered by intracavernosal injection and has already demonstrated key points of differentiation over the market leader, injectable
alprostadil. The market for non-oral drugs is an important, growing segment of the total ED market where existing oral treatments are associated with a number of side effects and are contra-indicated for a large number of individuals including those with diabetes and those receiving nitrate therapies for angina.
The 4m pounds convertible loan facility has a 39 month term with repayment scheduled to start in early 2008. The full amount of the loan has been drawn down on close. The convertible converts at the then prevailing market price capped at 188p. The aggregate of all conversions, under any circumstances, shall not exceed 10% of the prevailing market capitalisation.
Dr. Steven Powell, Plethora CEO, commented: “Following the recently concluded licensing agreement for PSD502 in the US, we are pleased to have secured this additional funding which enables us to complete the development and filing for registration of Invicorp, which we in licensed in 2006.
Through Timm Medical we have an established route to our target market for new, speciality therapeutics as well as continuing to grow revenues from the sale of medical devices. This allows us to retain a greater share of the value created in our development pipeline.
These are important steps towards our goal of building a sustainable, urology-focused specialty pharmaceutical company.”
A spokesman for ETV commented that this convertible loan facility aims to give Plethora the financial flexibility to execute on their current business plan with confidence and to complete the clinical development and filing for US market approval of Invicorp(R).
For further information contact: Plethora Solutions Steven Powell Tel : 020 7269 8630 City/Financial Enquiries Maitland Brian Hudspith/Liz Morley Tel: 020 7379 5151 Scientific/Trade Press Enquiries DeFacto Communications Tel: 020 7861 3838 Richard Anderson
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. In January 2006, Plethora acquired Minneapolis (Mn) based Timm Medical Technologies Inc which markets products for the treatment of erectile dysfunction (ED) to urology clinics through a US-based specialty sales team. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE) Further information is available at http://www.plethorasolutions.co.uk
Invicorp(R) is a patented injectable combination of phentolamine mesilate and vasoactive intestinal polypeptide. Published clinical data indicate that the efficacy and local tolerability profile of Invicorp(R) compare favourably with current non-oral drug treatment options for the treatment of ED. The product has marketing authorisation in Denmark and was launched there in September 2006. Invicorp(R) has also been approved in the UK and New Zealand.
The ED market is dominated by the oral phosphodiesterase (PDE5) inhibitor drugs. Although these are reported to be effective in around 70% of ED patients, oral ED drugs cannot be taken by men who require nitrate medications for angina and their effectiveness is substantially reduced in diabetic patients and in those recovering from prostate cancer or pelvic surgery. Plethora estimates that there are over 5.9 million men in the US alone for whom oral ED drugs are not a viable treatment option. Non-oral ED drug sales exceeded $31 million in the US in 2005 (IMS data). Upon approval, Invicorp(R) could be the first novel non-oral ED treatment to enter the North American market in over a decade.
About ETV Capital S.A.
ETV Capital S.A. is a specialty finance company that makes supportive investments in growing technology companies across Europe.
About Senetek PLC
Senetek PLC is a specialty dermatology and skincare company with a portfolio of intellectual properties targeting the science of aging, including skincare and dermatological therapeutics, erectile dysfunction and nutrition. Senetek recently granted Valeant Pharmaceuticals a paid up license for Senetek’s first generation patented skin care active ingredient Kinetin and its analog Zeatin in return for $21 million cash and forgiveness of $6 million prepaid royalty credit, and is negotiating third party license agreements for two patent-pending second generation dermatological active ingredients, Pyratine-6 and 4HBAP, and is completing development of a number of additional compounds. In addition, Senetek has entered into exclusive licenses for Europe and North America, respectively, for Invicorp(R), has an exclusive manufacturing distributorship for its proprietary diagnostic monoclonal antibodies, and recently sold, with retained rights of profit participation, its patented drug delivery system, Reliaject(R).
For more information, visit the company’s website at http://www.senetekplc.com/
This news release contains statements that may be considered ‘forward-looking statements’ within the meaning of the Private Securities Litigation Reform Act, including those that might imply FDA approval and commercial potential for Invicorp. Forward-looking statements by their nature involve substantial uncertainty, and actual results may differ materially from those that might be suggested by such statements. Important factors identified by the Company that it believes could result in such material differences are described in the Company’s Annual Report on Form 10-K/A for the year 2006. However, the Company necessarily can give no assurance that it has identified or will identify all of the factors that may result in any particular forward-looking statement materially differing from actual results, and the Company assumes no obligation to correct or update any forward-looking statements which may prove to be inaccurate, whether as a result of new information, future events or otherwise.
Senetek PLC
CONTACT: William F. O’Kelly Chief Financial Officer of Senetek, PLC,+1-707-226-3900 ext. 102
