Senetek licenses erectile dysfunction treatment Invicorp to Plethora

By E. Janene Geiss

Philadelphia, Feb. 21 - Senetek plc and Plethora Solutions jointly announced Tuesday the signing of an exclusive license for Plethora to manufacture and market erectile dysfunction treatment Invicorp in North America.

Under terms of the agreement, Plethora said it assumes full responsibility for the drug regulatory process for Invicorp and for establishing this important new therapy in the key North America market, which represents about 40% of global sales of erectile dysfunction treatments, according to a company news release.

Plethora also said it is granted options on additional non-North American markets outside of Europe.

Senetek said it will participate in the success of Invicorp through royalties based on Plethora's and its sub-licensees' net sales of Invicorp plus predetermined milestone payments upon achievement of regulatory approvals and cumulative net sales targets.

Invicorp is Senetek's patented injectable combination of phentolamine mesylate and vasoactive intestinal polypeptide for the treatment of erectile dysfunction.

The product already has received marketing authorization in Denmark, which has been chosen as the Reference Member State for the Mutual Recognition Procedure in Europe, as well as the United Kingdom.

The prevalence of erectile dysfunction as reported in international surveys ranges from 10% to 24%, officials said. Prevalence of the disorder increases with age and is almost threefold greater in men aged 70 or more than in men aged 40 to 49 years.

Current pharmacotherapy for erectile dysfunction comprises oral, injectable and transurethral treatments. The common oral agents are contraindicated in patients taking nitrate medications for angina or certain drugs for the treatment of benign prostate hyperplasia. Also, their efficacy is reduced in patients with diabetes and in those with nerve damage following prostate or pelvic surgery. Existing injectable and transurethral treatments are contraindicated in patients with certain medical conditions.

Invicorp, on the other hand, has a different mode of action to existing injectable and transurethral drugs and is not contraindicated in any patient population in those countries where it currently has marketing authorization, officials said. The product is self-administered using a microinjection system.

"Invicorp has great potential in the management of the large number of patients ... who have a poor or inadequate response to oral drugs and those patients who cannot safely take them. The latter category includes not only nitrate users but also some patients taking common medications for the treatment of benign prostatic hyperplasia. In this respect, like our existing Timm product line, Invicorp could become an attractive treatment option for many patients," Mike Wyllie, founder and chief scientific officer of Plethora, said in the release.

Senetek is a Napa, Calif., health care technologies company targeting the creation of products for the anti-aging market worldwide.

Plethora is a London specialty pharmaceutical company focused on the development and marketing of products for the diagnosis, treatment and management of urological disorders.

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