US-based Apricus Biosciences has (Apricus) has signed an exclusive licensing agreement with Italian firm Recordati for the marketing and sales of its topical on-demand product Vitaros for the treatment of erectile dysfunction (ED).

Vitaros will be marketed in Spain, EU member countries in Central and Eastern Europe, Russia, and the Commonwealth of Independent States (CIS), Turkey and certain African countries.

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The product is already approved for the treatment of erectile dysfunction by a number of European health authorities and by Health Canada.

It is a topically applied cream formulation of alprostadil, a vasodilator, which directly increases blood flow to the penis, causing an erection.

"The company said that alprostadil is an alternative to the PDE-5 inhibitors for difficult to treat patients."

The company said that alprostadil is an alternative to the PDE-5 inhibitors for difficult to treat patients, and Vitaros provides a patient-friendly form versus other alprostadil dosage forms.

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Under the terms of the deal, Apricus is eligible to receive around $3.8m from Recordati in upfront and pre-commercialisation milestone payments

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Apricus is also eligible to receive about $47m in sales milestone payments, plus double-digit tiered royalties based on Recordati’s net sales of the product in the Territory.

In return, Recordati will have the exclusive right to commercialise Vitaros in certain European and African countries.

Recordati has agreed to get all necessary regulatory approvals at its sole cost.

Apricus chief executive officer Richard Pascoe said: "This agreement, which marks the completion of our Vitaros licensing efforts in Europe, reflects our continued commitment to commercialising Vitaros through leading pharmaceutical companies such as Recordati in an effort to bring this best in class erectile dysfunction treatment to patients in 2014."

There are currently an estimated 150 million men worldwide who suffer from ED, and the market size of ED is around $1bn in revenues in Europe alone.