Futura Medical PLC on Monday said it agreed a licensing deal with Haleon PLC for the rights to exclusively commercialise Futura’s erectile dysfunction treatment Med3000 in the US.
In London, Futura shares surged 11.4% to 57.50 pence each on Monday morning. Haleon shares rose 0.7% to 316.50p each.
Futura is a Guildford, Surrey-based pharmaceutical company. It will receive an initial upfront payment of $4 million from Haleon, a Weybridge, Surrey-based consumer healthcare products firm and the owner of Advil.
Futura will also receive royalty payments on all sales by Haleon of the gel-based Med3000 treatment and potential commercial and performance-driven sales milestone payments ranging from $5 million to $45 million over the course of several years.
As part of the deal, Haleon will be responsible for the future launch and ongoing regulation, development, marketing and commercialisation of Med3000. Futura said that further details are set to be disclosed in ‘due course’.
Upon launch, Med3000 will represent the first over-the-counter topical gel indicated for the treatment of erectile dysfunction, which Futura said ‘disrupts the lives of at least one in five men globally’ and around 22 million men in the US.
Futura added that Med3000 has previously been approved as the first pan-European clinically proven OTC treatment for erectile dysfunction and is now available in the UK and Belgium. It was made available online in Europe in March under the name Erexon.
Last month, the US Food & Drug Administration granted OTC sale marketing authorising for Med3000 as a ‘de novo’ medical device. The de novo regulatory pathway is used when a product is considered ‘novel’ by the FDA, with no similar product already on the market.
Futura said at the time that more launches were planned this year in key markets including Switzerland, South Korea, Latin America, and the Middle East.
‘This agreement, with one of the world’s leading global consumer healthcare companies, represents a major milestone for Futura,’ said Futura Chief Executive Officer James Barder.
‘The US 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 USA who will soon be able to buy Med3000 in US pharmacies, without the need for a doctor’s prescription.’
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