Just a little over a month after receiving FDA approval for the first over-the-counter (OTC) topical therapy for erectile dysfunction (ED) called MED3000, Futura Medical has secured a powerful marketing partner in the US.
Haleon, a consumer health spinout of GSK, has acquired exclusive rights to commercialize the gel-based product in the US. In exchange, Futura Medical will receive an initial upfront payment of $4 million, potential milestone payments ranging from $5 to $45 million based on sales performance in the coming years, and ongoing royalties.
As an independent company established a year ago, Haleon will take charge of launching MED3000 in the US and handle all aspects related to regulatory affairs, development, marketing, and commercialization of the product.
MED3000 has already obtained medical device approval in the EU and UK and was introduced in the UK and Belgium in March under the brand name Eroxon through a partnership with Cooper Consumer Health. Further launches are planned in Switzerland, South Korea, Latin America, and the Middle East.
This partnership with Haleon significantly boosts Futura’s expectations for MED3000, as the company believes the product has the potential to achieve annual sales of up to $1 billion if it can establish a strong presence in the market.
Currently, ED is mainly treated with oral PDE5 inhibitors like Viagra (sildenafil) by Pfizer and Cialis (tadalafil) by Eli Lilly, or their generic versions, which require a doctor’s prescription in the US.
Futura also claims that MED3000 acts faster than other ED treatments, taking effect in just 10 minutes, while pills may take 30 to 60 minutes. Additionally, PDE5 inhibitors can have side effects and are not suitable for use with certain medications, making Futura’s non-systemic, over-the-counter option an appealing alternative.
The gel is applied to the penis head, stimulating nerve endings with a cooling and warming sensation, which helps in achieving and sustaining an erection. According to Futura, MED3000 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. 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.
– James Barder, chief executive
Following the announcement of the partnership, Futura Medical’s shares saw a spike of over 10%, although some of those gains have since receded, leaving the current increase at around 5%.
