Senetek PLC Announces Update On Invicorp(R)
North America Licensee Funds Completion of FDA Approval Process
NAPA, Calif., July 9 /PRNewswire-FirstCall/ -- Senetek PLC (OTC Bulletin Board: SNTKY), 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). |
