When life gives you lemons, make lemonade, say many people on the internet.
READ: Futura Medical well-positioned to announce more positive news on MED3000 after year of milestones
MED3000 is a topical gel based on the pharma company’s proprietary technology DermaSys, which helps the skin absorb the medication.
Unlike other treatments for ED, MED3000 is applied directly on the penis and is fast-acting: 60% of patients had onset of their erection within ten minutes in the clinical trials.
The journey to the final product has taken unexpected twists and turns but the Surrey-based company is about to reap the benefits of years of work with commercialisation expected as early as this year.
How it started
The initial formulation was MED2005, which was also a gel but contained a drug, meaning patients would need a medical prescription to access it.
Despite delivering a clinically meaningful benefit, it produced the same results as the placebo when tested on 1,000 patients with mild, moderate and severe ED across Europe.
The placebo didn’t contain the active pharmaceutical ingredient, called GTN, but used key components of Dermasys.
The surprising data, which was published in December 2019, meant that MED2005 couldn’t go ahead as a drug.
“When we investigated the reasons for that we found that the vehicle itself, the Dermasys vehicle, had remarkable efficacy in its own right,” Ken James, executive director and head of R&D, told Proactive.
“So, that the thought occurred: well, if the vehicle is so effective, maybe we could adopt a different regulatory process, because it doesn't contain a drug, and therefore could be classified as a medical device.”
Futura decided to focus its efforts on the gel used as a placebo, which it named MED3000.
Being a medical device, the regulatory pathway ended up being much faster than it would have been with MED2005.
The authorities in both Europe and the US were “very supportive”, James said, and allowed the company to go ahead with the new plans.
What’s even more impressive is that the route to medical device was carried out during a global pandemic, though James noted that the Zoom meetings may have perhaps sped up the process.
“The FDA and the European authorities didn't close shop, they remained open for business, and the whole process work properly more efficiently than we had realised. I don't think we've really missed a beat on this all the way through,” he commented.
A global plan
In February 2020, Europe started formal proceedings to make MED3000 available as a medical device throughout the bloc, leading to full approval last month.
The CE mark, which will allow commercialisation, is expected before the end of May 2021 and will also be valid in the UK until June 2023 thanks to post-Brexit arrangements.
Futura reckons that this certificate will pave the way for speedy registrations in most Middle East, Far East, African and Latin American countries so it can target global sales.
In preparation to this, it has clinched a deal with Atlantis Investments to cover sales in China and South-East Asia.
Under the agreement, the new partner will cover an estimated £4mln in development costs but will retain half of the profits.
US approval, instead, will take a bit longer because the US Food and Drug Administration (FDA) required a confirmatory trial.
The study, dubbed FM71, involves 100 participants and is led by Arthur Burnett, Professor of Urology at the prestigious Johns Hopkins University in Maryland.
It will last six months to reassure the FDA that the efficacy does not diminish over a longer period of time.
Futura said FM71 has a "least burdensome" approach and modest cost compared to the previous trial, which tested the previous formulation and the placebo on 1,000 patients.
According to house broker Liberum, MED3000 could deliver £110mln peak annual sales in the EU and £200mln in the US, while the Asian market is “worth multiples of the European opportunity”.
Pushing against an open door
James said that the company was “pushing against an open door” to make an ED product available over the counter in the US.
“I think, philosophically, [the FDA] would like the category to become available over the counter so people don't have to go to the doctor for their prescription every time, but they have concerns about the oral pills,” he told Proactive.
MED3000 doesn’t contain a drug so it is expected to have fewer side effects.
Conversely, Viagra is advised against men who have recently had a stroke or a heart attack and have low blood pressure, according to the NHS website.
Plus, Futura reckons it could reach more people, because men won’t have to get a prescription or, if they feel uncomfortable, their partners could buy it for them at the pharmacy – or even apply it for them as part of foreplay, as it happened 30% of the times during trials.
“Where we see a real opportunity is first of all, for men that don't want to pre-plan, they want something spontaneous with this rapid speed of onset,” chief executive James Barder told Proactive.
“One of the other things we've seen is a lot of doctors are concerned that there's a growing amount of erectile dysfunction in the younger population,” he continued.
“You're dealing with an entire generation of men who have grown up with freely available porn on the Internet and have this perception on how they should perform, and are presenting the doctor saying ‘I suffer from erectile dysfunction'. A lot of doctors are very concerned about putting men on treatments like Viagra.”
What’s on the market
Futura, who said no other company has developed a direct competitor to MED3000, are presenting their product as an alternative for those who don’t feel comfortable with the existing ED treatments.
As a result, the ED market is forecast to increase by 7% although MED3000 may also grab market share from the likes of Viagra.
These developments have been cheered up by the market, with shares rocketing 240% in the year to date.
“We expect continued momentum given the near-term catalysts of further out-licensing deals and the start of the US study,” Liberum commented.
“We expect the shares to further re-rate as management crystallises the value of MED3000 over the coming 6-18 months.”