Futura Medical LON:FUM, the Guildford-based pharmaceutical company, has had a exciting start to the week. The biotech company, established in 1997 to develop a topical cream for the treatment of male erectile dysfunction and listed on AIM in July 2003 has focused on developing treatments for sexual health and pain alleviation.
On Monday (12th June) the company announced that its leading therapy for erectile dysfunction, MED3000 – a cream that the firm claims has a 10-minute activation period – had been granted marketing authorisation by the US Food & Drug Administration (FDA) for over-the-counter sale.
The products that MED3000 are competing with – the famed Viagra and Cialis – are in the US prescription-only medications that are dispensed as oral-only tablets and need at least a 30-minute activation period.
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The new treatment from Futura, under the FDA’s De Novo Medical Devices programme (which provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device) is a major milestone for the company.
Passing FDA approval, even under the De Novo Medical Devices programme is a major hurdle. As we reported last week in the case of Hemogenyx LON:HEMO any delay can have repercussions on a biotech’s share price.
European pathfinding
Conversely, getting approval (MED3000 has already been approved as the first pan-European clinically proven topical treatment for erectile dysfunction available over-the-counter and is marketed in Belgium and the UK under the brand name Eroxon) can have a beneficial effect on share prices.
Futura Medical closed trading Monday (12th June) at 49p, falling from 55p at open, but up 50.6% more than the shares were trading at one year ago, with a -5.9% year-to-date return. The company’s shares have ranged from 27.35p and 61p over a 52-week period.
Futura is hoping to launch the product in other European markets as well as South Korea, Latin America and the Middle East.
James Barder, chief executive of Futura Medical said in a statement: “FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am delighted that we met this standard with MED3000’s submission of twenty-two clinical, biocompatibility, human factors studies and performance bench tests which were rigorously reviewed and accepted by the FDA. The FDA approval is a major de-risking event for the company, and we look forward to updating shareholders on our US commercialisation plans in due course.”
In its last financial statement for the year to end-December 2022, Futura reported losses of GBP5.85m, with GBP4.1m spent on R&D, which was more than the loss of GBP4.9m in 2021. The company has GBP4m in the bank, with the cash runway extending beyond the Eroxon/MED3000 launch.
Significant milestone
Broker, Liberum updated its target price for the small pharma firm to 142p following the MED3000 news. The broker said that the development marks a significant milestone for Futura, further strengthening the investment case in the Liberum’s view. The broker highlighted that the approval places MED3000 as the first over-the-counter (OTC) ED treatment to be approved in the US noting that compared with existing prescription-based treatments such as Viagra and Cialis, MED3000 offers easier accessibility and faster onset of effect.
MED3000 is the first approved treatment in Futura’s pipeline. The company is also developing a cannabis-based pain relief product CBD100 and diclofenac pain relief gel, TPR100. At the core of all the potential treatment is DermaSys, which delivers drugs through the skin to the required site of action with a high level of safety.
The announcement is undoubtedly a significant milestone for the company, however the next challenge for Futura is to find a commercial marketing partner for MED3000 in the US.
