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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.
Unfortunately, for regulatory and compliance reasons Futura Medical cannot answer individual enquiries, this is to avoid selective disclosure beyond the facts stated on the company website.
In order to meet the expectations of its shareholders, Futura Medical is committed to transparency and the disclosure of timely information.
All company updates disclosed to the market can be found here.
We have not changed our IR/PR service provider, Optimum Strategic Healthcare are appointed and will continue to provide IR/PR services. Brighter IR is the new 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 is working proactively with the FDA to confirm the least burdensome design of the new clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development. It is too early to comment on the cost other than to say it is expected that the study will be significantly smaller in size and therefore cost compared to the previous Phase 3 study FM57. Final clearance from FDA on the scope and design of the additional study will allow Futura to determine its cost and the study will not start until that clearance is received.
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 is currently a loss making company and therefore 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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For general enquires contact 0871 664 0300 (calls cost 12p a minute plus network extras, lines are open 9.00am-5.30pm Mon-Fri) (or +44 (0) 37 1664 0300 from outside the UK) between 09:00 and 17:30 on each business day.
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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.
Futura’s unique transdermal technology DermaSys® enables targeted and rapid delivery of clinically proven effective medical treatments through the skin.
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets while avoiding the risks normally associated with the development of new molecules.
DermaSys® is a versatile normally clear, odourless gel uniquely formulated using volatile solvent component formulations tailored for each product, to suit the specific therapeutic indication and desired speed of onset and duration of action. Each product is formulated to maximise its benefits for patients and consumers.
DermaSys® is a proprietary transdermal technology platform with very strong IP offering a high level of product differentiation compared to existing marketed treatments. Each new unique formulation offers the opportunity for additional patent applications and potential patent protection. Aside from our current patent lawyers, Futura recently retained a specialist biotech IP and strategic advice company to assist in maximising the robustness of the MED3000 intellectual property.
MED3000, our lead product, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction (“ED”). MED3000 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.
MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED. MED3000 is a unique formulation of DermaSys® using volatile solvent components tailored for the treatment of ED.
MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of ED.
MED3000 works through an evaporative and unique mode of action. MED3000’s combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis rapidly, leading to smooth muscle relaxation, tumescence and erection.
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.
These regulatory positions are the consensus from a number of regulatory experts consulted by Futura., nevertheless the Company is meeting with respective regulators ahead of regulatory filings. The Company is making progress with filing MED3000 for approval as a medical device in both Europe and the United States.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations. Futura continues to target a 2021 European approval date.
In the USA, arising from a second pre-submission meeting in July 2020 the FDA indicated a requirement for certain supplementary clinical efficacy data beyond the FM57 phase 3 study completed in 2019. This additional data will likely require a further small clinical study where patients with ED may receive MED3000 for a six-month treatment period. Futura is working proactively with the US FDA to confirm design of the new clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development.
This requirement to run a small confirmatory study of 6 month’s duration in addition to the completed large pivotal study, FM57 is significantly less burdensome than two large pivotal studies that would have been required as a drug product as opposed to a medical device. Final clearance from FDA on the scope and design of the additional study will allow Futura to determine its expected cost and the study will not start until that clearance is received.
In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations. Futura continues to target a 2021 European approval date.
In the USA, arising from a second pre-submission meeting in July 2020 the FDA indicated a requirement for certain supplementary clinical efficacy data beyond the FM57 phase 3 study completed in 2019. This additional data will likely require a further small clinical study where patients with ED may receive MED3000 for a six-month treatment period. Futura is working proactively with the US FDA to confirm design of the new clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development.
This requirement to run a small confirmatory study of 6 month’s duration in addition to the completed large pivotal study, FM57 is significantly less burdensome than two large pivotal studies that would have been required as a drug product as opposed to a medical device. Final clearance from FDA on the scope and design of the additional study will allow Futura to determine its expected cost and the study will not start until that clearance is received.
Currently there are no requirements for patients in clinical trials however as per the regulatory update on 22nd October 2020, the Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of a small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.
Patients interested in participating will be able to find details in due course on clinicaltrials.gov.
The DermaSys® control (now known as MED3000) showed very high levels of efficacy in mild, moderate and severe ED. The vast majority of subjects experienced a meaningful clinical improvement in their ED; up to 83%. This left limited ability to show additional improvement for MED2005.
All four formulations tested; the Dermasys® control (now known as MED3000) and the 3 formulations containing the active ingredient in the Dermasys® base, showed very high levels of efficacy in mild, moderate and severe ED when compared to the pre-treatment (baseline) level of ED. However, because the vast majority of subjects experienced a meaningful clinical improvement, up to 83%, with the Dermasys® control. This left limited ability to show additional improvement for MED2005.
An ED-specific DermaSys® formulation (now known as MED3000) was used as a control arm (placebo) following regulatory requirements, including the FDA in the US. The documented code requirement here is that the placebo must be as identical as possible to the test product. With respect to physical characteristics, placebos must have identical smell, colour, physical sensation on the skin to enable studies to be authentically blinded, disabling the patient from determining which is the drug and which is the placebo. The FDA acknowledge that not all placebos are inactive and to meet their requirements it was agreed in consultation with them that only the DermaSys® base would be appropriate.
The Phase 2 study did show a placebo effect which was expected as the massaging of gel into the glans penis will cause some sexual stimulation. However, the effect was much lower than experienced in the phase 3 study. We believe the greater effectiveness in the Phase 3 study is a result of two main factors.
Therefore, we have concluded that in moving from a small Phase 2 study to a large Phase 3 study that the placebo effect was far greater than first indicated and presents an exciting opportunity in its own right without the inclusion of a drug substance.
As mentioned in the July 2020 RNS, the next steps will be to confirm design of the new clinical trial with FDA to provide the necessary reassurance of MED3000's efficacy for up to six months' and progress the OTC label and leaflet development. The requirement of FDA for Futura to run a small confirmatory study of 6 months duration in addition to the completed large pivotal study, FM57 is significantly less burdensome in the Board's view than two large pivotal studies of 12 and 3 months' duration that would have been required as a drug product as opposed to a medical device.
Eroxon® is the registered and suggested brand name for Futura’s topical gel for ED, though potential distributors may choose to use other brand names.
MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED.
MED2005 or MED2002 are the codenames used by Futura for all proprietary formulations containing Glyceryl Trinitrate (GTN).
Currently there are no requirements for patients however as per the regulatory update on 22nd October 2020, the Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of a small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.
Patients interested in participating will be able to find details in due course on ClinicalTrials.gov.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
The recruitment for the clinical study has closed and the study completed. For further details on the trial, please visit ClinicalTrials.gov.
After the Phase 3 FM57 study indicated the value and efficacy of MED3000 (a formulation developed specifically for the treatment of ED) a new patent application was filed in December 2019 which has the potential, if successful, to extend protection of MED3000 until 2040. Aside from our current patent lawyers, Futura recently retained a specialist biotech IP and strategic advice company to assist in maximising the robustness of the MED3000 intellectual property.
MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In addition EU rules grant a 10 year protection. Futura would benefit from a period of 8 years’ exclusivity during which data generated by Futura cannot be used for an MAA to support their application. In addition, no generic of the product may be marketed for 10 years after the first approval.
In August 2018 Futura filed a Patent Co-operation Treaty patent application which, if successful, could extend patent protection for MED2005 in many countries to 2038. The PCT filing will be moving into the National filing phase in Q1 2020 in line with standard processes. This phase sets out specific, nominated countries under the Patent Co-operation Treaty which, if successful, will provide patent coverage until 2037.
Futura is pursuing the medical device regulatory pathway for its proprietary transdermal formulation MED3000 in the US and Europe.
Results of the FM57 study can be found here
As previously commented following the hand back of rights by both Reckitts Benckiser and C&D without a strong brand carrier CSD500 no longer remains a priority for Futura. Futura continues to assist its other licensees in their efforts to launch CSD500 but Futura has no plans for future development work for CSD500.
This is a choice for the local distributor.
We cannot comment on specific countries but in MENA & EU.
In February 2019, the UK Medicines and Healthcare products Regulatory Agency (MHRA) responded to Thornton & Ross’s marketing authorisation application filed in July 2018, raising a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted.
As mentioned in the Interim Results for the Six Months ended 30 June 2020 (September 2020 RNS) post period events:
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets whilst avoiding the risks normally associated with the development of new molecules.
The rapid skin permeation rate offered by our transdermal delivery system, DermaSys®, is ideally suited for targeted topical pain relief. Rapid, targeted and effective skin permeation offers potential benefits in pain management including: improved onset of action, duration and degree of pain relief.
TPR100 does not require a combination of volatile solvent components to stimulate nerve sensors. It is designed to provide a sustained mode of action suitable for the treatment of pain and is formulated with this objective in mind.
TPR100's current patent protection runs until February 2028 in the USA and Europe.
CBDerma Techology is a shell company that has been established with backers that have experience in plant derived products. Futura announced a joint venture collaboration with CBDerma Technology Limited in September 2019 to explore the application of Futura’s advanced proprietary transdermal technology, DermaSys® for the delivery of cannabidiol.
The cosmetic market is already significant with the UK, we understand, over £300 million. As a topically applied pharmaceutical the potential is very significant, with currently very little credible scientific research conducted on topical formulations.
DermaSys® provides rapid and targeted local delivery of active pharmaceutical ingredients (API) at therapeutic levels and Generally Recognized As Safe (GRAS) pharmaceutical excipients onto and through the skin to the required site of action with a high level of safety. It is a versatile and bespoke technology that can be tailored to suit the specific active compound being used and the therapeutic indication. Each product is formulated to maximise its benefits for patients and consumers and can be developed for the prescription and consumer healthcare markets as appropriate.
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets whilst avoiding the risks normally associated with the development of new molecules.
At this stage the formulation for CBD100 is still under development and is not yet fully optimised. Nevertheless, CBD100 does not require a combination of volatile solvent components to stimulate nerve sensors. It is designed to provide highly efficient penetration of cannabidiol into and through the skin with a stability expected to ensure potency is retained during shelf-life.
A patent application was filed in the UK in August 2020.
We would expect to receive an initial search report on the ‘patentability’ of such application within six months. This will provide details of other patents or application already in existence which may affect the novelty and inventiveness of any new application. This may result in some amendment to the patent application ahead of a PCT application next July.
We are aiming for CBD100 to be highly differentiated from existing, largely un-regulated, low-tech products in the fast growing cannabidiol market on the basis of quality, stability and efficient delivery to the skin for a number of applications and indications expected to range from cosmeceutical through to pharmaceutical dermal and pain relief treatments. We have now started to explore commercialisation options for CBD100 with CBDerma as stability work continues in parallel. These options will also be influenced by the regulatory landscape around Cannabis which continues to evolve in the EU and USA.
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 £4,000.
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 board see significant commercial potential for MED3000 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 accessibility to ED sufferers throughout the EU and USA. This sentiment is shared with a number of potential commercial partners with whom Futura is now actively engaged in discussions, and we have a process in place.
As indicated in October 2020, discussions continue with a growing number of parties in line with an agreed process being managed by Futura's corporate, commercial advisers. Nevertheless, priority has been given to certain negotiations for one specific region where discussions have advanced with parties for the exclusive marketing rights for MED3000. The Company has reasonable expectations that these negotiations will be satisfactorily concluded with one of several interested parties although no guarantees can be given at this stage that any of these negotiations will conclude successfully.
You must be able to provide proof of shareholding to participate in the audio-only conference call. If your shares are not held in your name (e.g. held in a nominee or pension account), you must provide the Company with a letter of representation from the shareholder which is listed on the shareholder register before access will be granted.
The government published in September 2020 its changes in regulating medical devices from 1st January 2021. This includes placing medical devices on the market and manufacturing and supplying devices in the UK. Read more here: https://www.gov.uk/guidance/regulating-medical-devices-from-1-January-2021
MED3000 is currently undergoing Notified Body assessment for initial European CE-marking, with grant of the CE-mark expected in 2021. The UK Competent Authority (MHRA) have confirmed that the UK will continue to recognise EU CE-marked devices until 30th June 2023.
From 1st July 2023, a separate UK Conformity Assessment (UKCA) mark must be applied to the MED3000 device labelling to allow it to continue to be placed on the market in Great Britain which will be applied for ahead of this deadline.
After the Phase 3, FM57 study indicated the value and efficacy of MED3000 (a formulation developed specifically for the treatment of ED) a new UK patent application was filed in December 2019, which was supplemented with a further UK filing in September 2020. Aside from Futura's current patent lawyers, the Company also consulted a further IP specialist to assist in maximising the robustness of the MED3000 intellectual property.
The UK is one of over 150 contracting countries to the Patent Cooperation Treaty (PCT). As is common practice in the securing of patent protection an initial patent is most often in the patent inventor’s domicile, which establishes the priority date of any potential patent in all contracting countries to the PCT. In October 2020 Futura filed a PCT application which will take over the priority dates and applications for the two MED3000 UK applications.
The next steps will involve the initial publication of the PCT application in 2021 before proceeding into national phase where Futura will nominate those countries within the PCT were it wishes to apply and hopefully secure patent protection. If successful it will provide patent protection until 2040 in those nominated countries subject to payment of the applicable maintenance fees.
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 volatile solvent component 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.