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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.
Please register for our news alert service.
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 May or 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 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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The Registry
34 Beckenham Road
Beckenham
Kent
BR3 4TU
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.
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.
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.
Futura now plans to pursue the medical device regulatory pathway for MED3000. Futura has commenced formal proceedings for MED3000 as a clinically proven treatment for ED to be approved as a medical device for the treatment of ED. Futura is expecting to submit the dossier to EU regulators by the end of July 2020 with the U.S. FDA providing optimism for submission for a medical De Novo device approval filing by end of Q3 2020.
Futura will submit its technical file for review by an EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK), including the full clinical study report for FM57 and the Company’s Quality Management System.
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. The regulatory pathway for a medical device is expected to be faster. An EU Notified Body has confirmed that MED3000 is a medical device and the US FDA has confirmed that the classification for the filing of MED3000 is a De Novo medical device.
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.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
MED3000 discussions are progressing well with regulators with an EU filing expected by the end of July 2020 and with positive dialogue with the US FDA providing optimism for a submission for a medical de novo device approval filing by the end of Q3 2020.
The recruitment for the European Phase 3 study (FM57) is now closed.
MED3000 achieved all co-primary clinical endpoints against baseline (before treatment). We are now pursuing regulatory filings as a medical device in the EU and US.
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.
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).
The recruitment for the European Phase 3 study of (FM57) is now closed and the study has completed.
For further details on the trial, please visit 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. Ongoing laboratory work continues with formulation dosing adjustment and in vitro studies to enable TPR100 to meet the strict criteria established by the MHRA (to avoid the need to conduct a Phase 3 pain relief efficacy study) delaying the response to the MHRA by at least six months.
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 a sustained mode of action suitable for the treatment of pain and is being formulated with this objective in mind.
At this stage the formulation for CBD100 is still under development and is not yet fully optimised. A patent application will only be filed once the formulation is optimised. Optimisation work is progressing, and the first stage of this will be complete by end of July 2020 before the next stage of early proof of concept studies are being considered.
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.
The Board recognises the ongoing importance of communication with shareholders at this time. The Company will be providing an audio-only conference call link to enable shareholders to follow proceedings of the meeting. Any shareholders who wish to follow the meeting by should contact the Company Secretary prior to the day of the meeting by 4pm BST (UK) at investor.relations@futuramedical.com in order to request conference dial-in details and to provide the requisite identification documents.
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.