NAPA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- Senetek PLC , a life sciences product development 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, has announced that following positive discussions with the United States Food and Drug Administration, Plethora Solutions intends to initiate the final component of the clinical development program for Invicorp(R) in the U.S. in the second quarter of this year. The phase III program, in up to 30 sites in the U.S., is anticipated to take approximately 12 months to complete.
Plethora licensed the exclusive North American rights to Invicorp(R) from Senetek in the first half of 2006. Invicorp(R) is a patented injectable combination of phentolamine mesylate and vasoactive intestinal polypeptide. Clinical data indicate that the efficacy and local tolerability profile of Invicorp(R) compare favorably with currently used injectable therapies. The product has already received marketing authorization in Denmark, which has been chosen as the Reference Member State for the Mutual Recognition Procedure in Europe, as well as in England. During 2005, Senetek entered into an exclusive license of European rights to Invicorp with Ardana Bioscience Ltd. of Edinburgh. Additionally, Invicorp(R) has been approved in New Zealand.
In Plethora Solutions’ announcement, Professor Tom Lue, Vice Chair of Urology, UCSF and President of the Sexual Medicine Society of North America, commented, “The arrival of Invicorp into the US market should make an invaluable addition to our therapeutic armamentarium for many men, in particular those individuals for whom phosphodiesterase inhibitors give an unsatisfactory response or are contra-indicated and for those who like the quality and the speed of onset of an injectable.”
Current pharmacotherapy for erectile dysfunction includes oral, transurethral and injectable intracavernosal treatments. The non-oral erectile dysfunction market was estimated as $85 million worldwide in 2003, with $45 million of sales in Europe and $32 million in the US (Source: IMS MAT Sept 03).
Dr. Mike Wyllie, Plethora CSO, commented: “Once again this re-enforces the value of the Plethora approach of developing products with large existing safety databases, ensuring a relatively rapid entry into the marketplace. Although there are marketed products in this segment of the market, we feel that Invicorp has a key point of differentiation. Invicorp injection is essentially pain free whereas the marketed products have been shown to produce compliance-limiting pain at the injection site in over 30% of men.”
Frank Massino (CEO, Senetek) stated “We are extremely encouraged at the speed with which Plethora is moving Invicorp(R) towards the U.S. market. Leading market researchers have continually expressed that physicians eagerly await the availability of Invicorp(R) in the U.S.”
Under the terms of Senetek’s February 2006 license agreement with Plethora Solutions, Senetek will receive royalties on net sales of Invicorp(R) and milestone payments upon achievements of certain events.
About Senetek PLC
Senetek PLC is a life sciences product development company with a portfolio of intellectual properties targeting the science of aging, including skincare and dermatological therapeutics, erectile dysfunction and nutrition. Kinetin, Senetek PLC’s lead commercial product, is currently licensed and marketed by 10 pharmaceutical and cosmeceutical companies, including Valeant Pharmaceuticals International and The Body Shop. In addition, the Company has entered into an exclusive global license with Valeant for Senetek’s proprietary anti-aging skincare compound, Zeatin, has entered into exclusive licenses for Europe and North America, respectively, for its patented combination drug treatment for erectile dysfunction, 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 2005. 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.
This document is available on the KCSA Worldwide Website at http://www.kcsa.com.
Investor Contacts KCSA Worldwide Todd Fromer/Garth Russell 212-896-1215/212-896-1250 tfromer@kcsa.com/grussell@kcsa.com
Senetek PLC
CONTACT: Todd Fromer, +1-212-896-1215, tfromer@kcsa.com, or Garth Russell,+1-212-896-1250, grussell@kcsa.com, both of KCSA Worldwide for Senetek PLC
Web site: http://www.senetekplc.com//
