Futura Medical PLC (AIM:FUM, OTC:FAMDF, FRA:GYX) chief executive Alex Duggan talked with Proactive about the company's new US commercial partnership for Eroxon and encouraging new clinical data for its women's sexual health product candidate, WSD4000.
Duggan explained why Futura Medical selected Market Performance Group (MPG) as its new US commercial partner, highlighting the group's extensive experience in consumer healthcare and its role in managing commercial execution, advertising, distribution and customer operations. He said the agreement represents a shift from a traditional licensing model to a more actively managed commercial strategy, allowing Futura Medical to retain greater control over brand strategy, promotional investment and product supply while leveraging MPG's expertise in the US market.
Head of R&D Ken James discussed the latest findings from two WSD4000 studies designed to support development of a novel over-the-counter treatment for female sexual dysfunction. A home user study involving 228 women demonstrated high levels of reported improvement across several measures of sexual function, while a separate placebo-controlled study showed statistically significant differences between WSD4000 and the sham comparator, providing confidence for the planned pivotal clinical trial.
James outlined plans to begin the Phase 3 clinical programme, subject to funding, with regulatory submissions expected after completion and a potential launch targeted for early 2028 in both the US and Europe.
Reflecting on the progress, Duggan said: "These results really are incredibly positive, and it does give us a lot of confidence, both in moving towards the phase three pivotal trial, which is now significantly de-risked as a result of this evidence, but also it gives us an indication as to the likely market success."
The interview also covered the commercial opportunity for Eroxon, the strategic evolution of Futura Medical's business model, and the company's broader growth ambitions across its product portfolio.
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Proactive: Alex, Ken, very good to speak with you. I'll start with you, Alex. You announced a new partner in the US. Can you give listeners some background on Market Performance Group?
Alex Duggan: First of all, I'm absolutely delighted to be partnering with MPG. Anybody who knows the US market knows the company has an excellent reputation and a great track record. I've worked with MPG successfully in the past on both transition and commercial arrangements, and found the team to be excellent and very easy to work with.
MPG manages multi-billion-dollar revenues for clients across consumer healthcare, personal care and household goods. Consumer healthcare is of particular strategic interest to the company, and with Eroxon already generating around $5 million in trade-level sales, it provides a strong platform from which MPG can build. Eroxon will immediately be an important brand within the portfolio.
Proactive: How will the new partnership work in practice, Alex?
Alex Duggan: In our April announcement, we concluded our strategic review, which included an evaluation of our commercial model. The MPG agreement is a good example of that new approach.
We're moving away from what I describe as a "launch and step back" model, which was our previous arrangement with Haleon under a traditional licensing agreement, towards a more actively managed, optimised hybrid model.
Under this structure, MPG will be responsible for commercial relationships, execution of advertising and promotional activities, customer service, warehousing and distribution. Together, we'll manage the brand and promotional strategy, while Futura Medical will remain responsible for product quality, supply and ongoing R&D.
Importantly, Futura Medical retains control over the level of advertising and promotional investment. This model combines MPG's strengths in sales, marketing and operational execution with our expertise in R&D, market insight and supply. For Eroxon at this stage of its development, we believe it's the right commercial model.
Proactive: You also reported very positive study results for WSD4000. Ken, can you explain what these findings mean?
Ken James: WSD4000 is the codename for a unique product designed to treat female sexual dysfunction. We've now completed two very encouraging studies that reinforce our belief that this could become the first clinically proven, regulatory-approved, multi-symptom treatment for women in this area.
These results build on an earlier feasibility study involving 12 women, which gave us strong early indications of efficacy.
The first new study was a home user trial involving 228 women. Participants used the product four times over a four-week period and we saw marked improvements in sexual function.
Some of the key findings included:
- 78% of women reported a general improvement in all or most aspects of sex.
- 78% reported a more satisfying sexual experience.
- 75% reported increased interest in having sex.
We also asked participants how they would rate the product if it were available commercially. Sixty-eight per cent said they would give it four or five stars.
Overall, 77% of participants reported an improved sexual experience after initial use, rising to 84% after four uses, suggesting efficacy increases with repeated use. The product was also very well tolerated, with 84% of women saying they liked its sensory and tactile feel.
Overall, we're highly encouraged by both the performance of the product and its commercial potential.
The second study focused on supporting future regulatory approval. Following discussions with the US FDA, we conducted a placebo-controlled study, referred to as a "sham" study for medical devices, comparing WSD4000 with an inactive control.
The crossover study involved 33 women and demonstrated that the sham was effectively inert while WSD4000 produced a highly active response. We achieved statistically significant differences between the treatments from one minute through to 15 minutes, which is the key timeframe for sexual activity.
These results give us confidence that we can now design a pivotal clinical study capable of demonstrating both the overall benefit of WSD4000 and a clear differentiation from the sham comparator.
Proactive: What are the next steps in development, Ken?
Ken James: Subject to funding, we hope to begin the pivotal clinical study before the end of this year, with the first patient visit taking place before year-end.
We're currently finalising the detailed study design. We expect the trial to complete during next year, after which we'll submit a regulatory filing to the FDA.
The product will be reviewed as a De Novo medical device because it's a novel treatment. Assuming approval, we are targeting a commercial launch in early 2028 in the US, with Europe expected to follow on a similar timetable using the same clinical data.
Proactive: Alex, can you summarise what these two important milestones mean for the company and how you're feeling about the future?
Alex Duggan: I'm genuinely excited about both developments.
The partnership with MPG is an excellent opportunity for Eroxon and we believe there is a significant commercial opportunity in the US market.
As you've heard from Ken, the latest WSD4000 results are incredibly positive. They significantly de-risk the planned Phase 3 pivotal study and also give us confidence in the product's commercial prospects.
WSD4000 has the potential to become the first clinically approved over-the-counter treatment for female sexual dysfunction anywhere in the world. The efficacy we've seen is strong and the feedback from women participating in the studies has been extremely positive. Those factors give us confidence ahead of a potential launch in early 2028.
Overall, I believe there are significant opportunities ahead for Futura Medical. We have strong assets in Eroxon, Eroxon Intense and WSD4000, all supported by an experienced R&D team together with our commercial and market insight capabilities.
I'm looking forward to unlocking the value of our portfolio. I'd also like to thank our shareholders for their continued patience and support as we continue our journey towards growth.
Proactive: Alex, Ken, thank you both for your time. We look forward to hearing more as these programmes progress.
