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Futura Medical’s headquarters are based in Guildford, Surrey, UK. Please see our Location for further information.
Futura Medical plc is quoted on AIM and the ticker symbol is FUM.
Please see our Directors and biographies.
Please see our Financial Calendar.
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Online versions of our recent Annual Reports and results statements are available in the Investor Centre section of our website, and can be downloaded here. You can also request a hard copy of the company's annual report by emailing investor.relations@futuramedical.com.
The AGM usually takes place in June each year. Confirmed dates are listed in our Financial Calendar.
Please see details of our Analyst coverage here.
Please find the necessary contact details here.
We have not changed our IR/PR service provider, Optimum Strategic Communications are appointed and will continue to provide IR/PR services. Brighter IR is a provider we use to feed share price information to our website and to provide the news alert service which enables users who are registered with their service to receive alerts when regulatory news is released to the Futura website.
With the introduction of GDPR, Brighter IR requires your permission to use your personal information to contact you and this is done via their registration. Please note that once registered, you will begin to receive news alerts via email. You do not need to log into the Brighter IR portal to access the press releases, they are available on our website through the automated feed. The Brighter IR portal is to allow you to amend or delete the permissions you have given to them to access your personal information and to contact you via the alert service.
Futura Medical plc is quoted on AIM and the ticker symbol is FUM.
Futura Medical shares can be bought and sold through a stockbroker or share dealing service.
Please see our Shareholder Information page.
No, Futura currently does not pay a dividend.
You will need to complete a share transfer form, which can be obtained from the Registrars. The form should be fully completed and returned to them with your share certificate to arrange transfer of ownership.
You will need to contact the Registrars for this information.
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If you have changed your name or home address you should notify the Registrars in writing. Please quote your full name, the old and new addresses, and/or provide documentary evidence (such as a copy of your marriage certificate or change of name by deed poll), as applicable. You should also enclose your share certificate for amendment.
You should notify the Registrars. Restriction will then be placed on the missing share certificate in case of any attempted fraud. A letter of indemnity will be sent to you to sign. Once completed and returned to the Registrars a replacement certificate can be issued. There is a charge for this service. If the missing share certificate subsequently appears, you should return it to the Registrars to be cancelled.
Please contact the Registrar, who will be able to assist you.
Eroxon® is the branded name used by a number of distributors whereas MED3000 is the codename used by Futura during the product development. The use of Eroxon® as a brand name will nevertheless will be dependent from country to country dependent on a number of factors, such as regulatory approval, which may be outside the control of Futura or the distributor.
Eroxon®, our lead product was developed specifically for the treatment of erectile dysfunction (“ED”). Eroxon® is a fast-acting topical treatment which has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market.
Eroxon® is a topical gel applied directly to the head (glans) of the penis for the treatment of ED.
Eroxon® works through a unique evaporative mode of action. Eroxon® combination of volatile components creates a novel cooling and recovery warming action that stimulates nerve sensors in the highly innervated glans penis, rapidly leading to smooth muscle relaxation, tumescence and erection.
The efficacy of Eroxon® has been demonstrated in two Phase 3 trials in 300 men with mild, moderate, and severe ED, which investigated improvement in their erectile function compared with baseline.
Reported side effects of Eroxon® in the trials were minimal: 3% of men reported a headache, significantly fewer than associated with the PDE5i’s, 1% of men reported a ‘localised burning sensation’ and 1.3% of partners reported a headache.
Eroxon® is for use in men who experience ED. It should not be used by those who do not have problems with ED.
No, Eroxon® is the first clinically proven topical therapy for erectile dysfunction that can be bought in the UK without the need for a prescription, over the counter at Boots and Boots.com and other pharmacies and retailers. Eroxon® is also available online in Italy, France and Spain and in the United Arab Emirates.
Eroxon® launched in April in the UK and was initially available on boots.com and in store. It is also now available in other pharmacies and retailers across the UK.
A medical device is described within the EU as a product which does not achieve its principal intended action on the human body by pharmacological, immunological or metabolic means.
Registration of Eroxon® as a medical device is endorsed by both EU and US regulatory authorities in April 2021, the Company announced that it has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 (“CE mark approval”).
In 2022, Futura received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.
In June 2023, MED3000 was granted marketing authorisation by the US FDA for over the counter sale.
Eroxon® became available in the UK and in Belgium online and in store in April 2023 and has since become available online in Italy, France and Spain. Further online and retail launches supported by advertising and promotion are expected over the coming months.
Futura's breakthrough, topical gel formulation Eroxon® will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
Eroxon® became available in the UK and in Belgium online and in store in April 2023 and has since become available online in Italy, France and Spain with more countries to follow. On 18 April, Eroxon® became available on boots.com and in store in the UK. It is also now available in other pharmacies and retailers in the UK.
Launch within the United Arab Emirates also commenced at the beginning of Q4 2023.
Further launches are planned throughout the remainder of 2023 and beyond.
MED3000 received the US Food and Drug Administration marketing authorisation as an OTC product on 9 June 2023 as a De Novo medical device.
On 17 July 2023, Futura Medical announced that it had entered into a ground breaking licensing agreement with Haleon plc ("Haleon"), a world leading consumer healthcare Company for the rights to exclusively commercialise the Company's innovative topical, gel-based Erectile Dysfunction ("ED") treatment MED3000, in the USA. Haleon is responsible for the future launch and ongoing regulatory, development, marketing, and commercialisation of MED3000 in the USA. Further details will be disclosed in due course.
MED3000 has been granted marketing authorisation in a growing number of countries across the world which now include Mexico, six countries in the Middle East (including Saudi Arabia) and Australia.
Futura has signed commercial deals across the world covering Europe, the USA, Central and South America, the Middle East and South Korea with the first launch outside of Europe, in the United Arab Emirates, having commenced at the beginning of Q4, 2023 with further launches expected over the coming months:
August 2021: m8 Pharmaceuticals to commercialise MED3000 in Brazil and Mexico, which was expanded in November 2023 to a further fourteen countries covering the Central and South American region.
September 2021: Labatec Pharma to commercialise MED3000 in the Gulf and Middle East Region.
March 2022: A. Menarini Korea Limited for the exclusive rights to MED3000 in South Korea.
May 2022: Cooper Consumer Health to commercialise MED3000 throughout the European Economic Area, United Kingdom and Switzerland.
In 2023, Futura signed or expanded the following commercial deals:
July 2023: Haleon to exclusively commercialise MED3000 in the USA.
November 2023: Futura expands partnership with M8 Pharmaceuticals.
All distribution will be handled by our appointed distribution partners and retailers. Eroxon® addresses the significant and specific medical needs of men who suffer from erectile dysfunction and its use, where approved to be a treatment without the need for a doctor’s prescription, will require careful consideration by the patient in terms of self-diagnosis and use according to product label information.
At this time, we have not tested the product in patients who have undergone radical prostatectomy although the product has been shown to be effective in mild, moderate and severe ED of mixed causes.
If you have a medical condition you may need to speak to a doctor to discuss your condition to see if the product is suitable for you to use.
MED3000 is accompanied by a leaflet, containing warnings and precautions and recommending users have a check-up with their doctor as soon as possible within the first 6 months of using MED3000 to ensure that their erection problems are not caused by another serious health condition.
We have not conducted studies on Eroxon® in combination with PDE5i’s. It is likely that a post-approval study will be needed to demonstrate synergy. We do not anticipate any safety issues in combining the two treatments.
We have a shelf life of 3 years.
It is currently being sold in the UK in Boots for £24.99 for 4 single use applications.
FM71 was a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to a well-known US prescription oral medication for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000.
FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from the United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED, or a combination of both.
Patients enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the ‘baseline’, after which MED3000 was used per trial protocol for 24 weeks.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here
In August 2022, Futura announced positive results from the confirmatory Phase 3 clinical study, “FM71” for MED3000, for the treatment of erectile dysfunction.
· FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks
· Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study
· Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function and was clinically effective in mild, moderate and severe ED sufferers
· Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile
MED3000 presents an effective clinically proven treatment for erectile dysfunction (“ED”) with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter (“OTC”) classification.
In June 2023, MED3000 was granted marketing authorisation by the US FDA for over the counter sale.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here
Futura does use the services of a number of Key Opinion Leaders (KOLs) on an advisory basis which may result, at times, in financial payments being made. These payments are in line with current market rates and also in accordance with the guidelines set out by the Prescription Medicines Code of Practice Authority (PMCPA), which states: “No gift, pecuniary advantage or benefit may be supplied, offered or promised to members of the health professions or to other relevant decision makers in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.”
The maximum payment made by the Company was £5,000.
In parallel with the regulatory processes and executing upon strategic plans, Futura has retained specialised corporate advisers with international experience to facilitate active commercial discussions with potential licensing and marketing partners.
Futura management and the Board see significant commercial potential for Eroxon® as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its high tolerability and rapid speed of onset and may be available without the need of a doctor’s prescription, bringing treatment accessibility to ED sufferers globally.
Futura has signed commercial deals across the world covering Europe, the USA, Central and South America, the Middle East and South Korea.
August 2021: m8 Pharmaceuticals to commercialise MED3000 in Brazil and Mexico which was expanded in November 2023 to a further fourteen countries covering the Central and South American region.
September 2021: Labatec Pharma to commercialise MED3000 in the Gulf and Middle East Region.
In 2022, Futura entered into the following commercial deals:
March 2022: A. Menarini Korea Limited for the exclusive rights to MED3000 in South Korea.
May 2022: Cooper Consumer Health to commercialise MED3000 throughout the European Economic Area, United Kingdom and Switzerland.
In 2023, Futura signed or expanded the following commercial deals:
July 2023: Haleon to exclusively commercialise MED3000 in the USA.
November 2023: Futura expands partnership with M8 Pharmaceuticals.
Futura has appointed a special corporate adviser regarding commercial discussions for MED3000 marketing rights in other countries. Please see more information here:
https://polaris.brighterir.com/public/futura_medical/news/rns/story/xlqj57w
An initial UK patent was filed in December 2019 around MED3000’s clinically significant and novel findings shown in FM57, followed by further supplementary UK filings to establish a priority date prior to a Patent Cooperation Treaty (“PCT”) and certain non-PCT patent applications in late 2020.
The PCT currently has 153 contracting countries where the Company can seek patent protection claiming priority from an original application such as the UK.
An application to the European Patent Office was made in August 2021 for examination, and further national applications in line with the normal PCT filing procedure will be made in Q2 2022 in those countries considered necessary to protect the commercial interests of MED3000.
On 2 October 2023, Futura announced that the European Patent Office granted a patent for MED3000, providing protection to 2040.
In all other key ED markets including the US, the Company is continuing to prosecute patent applications to provide wider patent protection and further options for patent filings to extend scope of protection is also progressing.
Futura's unique patented technology DermaSys® is designed to deliver clinically proven effective medical treatments via the skin.
DermaSys® is a versatile and bespoke technology. Each product gel is uniquely formulated using the DermaSys® platform with permeation and penetration enhancer components formulations tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action. Such targeted delivery offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile reducing the risk of side effects. Each product is formulated to maximise its benefits for patients and consumers. Each new unique formulation offers the opportunity for additional patent applications and potential patent protection.