Haleon nabs rights to Futura’s OTC erectile dysfunction gel

Just over a month after getting FDA approval for the first over-the-counter (OTC) topical therapy for erectile dysfunction (ED), Futura Medical has lined up some heavyweight marketing muscle in the US.

GSK’s consumer health spinout Haleon has acquired exclusive US rights to commercialise the gel-based product, called MED3000, in return for an initial upfront payment of $4 million, milestone payments of between $5 and $45 million tied to sales performance over the next several years, and royalties.

Haleon – which was set up as an independent company a year ago – will be responsible for the launch of MED3000, as well as all “regulatory, development, marketing, and commercial” activities for the product.

MED3000 has already been approved as a medical device in the EU and UK and rolled out in the UK and Belgium in March under the Eroxon brand name, under an agreement with Cooper Consumer Health. Additional launches are planned in Switzerland, South Korea, Latin America, and the Middle East, according to the company.

Getting Haleon on board is a massive boost to Futura’s hopes for the product, which it reckons has the potential to make sales of up to $1 billion a year if it can carve out a niche in the market.

At the moment, ED is mainly treated with oral PDE5 inhibitors, like Pfizer’s Viagra (sildenafil) and Eli Lilly’s Cialis (tadalafil), or their generic equivalents, but these can only be obtained with a doctor’s prescription in the US.

Futura also claims MED3000 acts faster than other ED treatments, getting to work in just 10 minutes, while the pills can take 30 to 60 minutes to kick in. Meanwhile, PDE5 inhibitors can have side effects and are contraindicated with some medicines, so the company is hoping that its non-systemic, OTC option will become a popular alternative.

The gel product is applied to the head of the penis, stimulating nerve endings with a cooling and warming sensation that helps with getting and maintaining an erection and, according to Futura, is suitable for men with mild to severe ED.

“This agreement, with one of the world’s leading global consumer healthcare companies, represents a major milestone for Futura,” said the UK-based company’s chief executive, James Barder.

“The USA is the largest ED market in the world and we believe Haleon, with its strong capabilities in brand-building and marketing through an unrivalled breadth of channels, as well as its connections and market reach, makes it the ideal partner to introduce MED3000 to the millions of ED suffers in the US,” he added.

Shares in Futura spiked more than 10% this morning in the wake of the announcement, but have since lost some of those gains, currently up around 5%.