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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 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 on 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.
Link Asset Services
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.
Unfortunately, whilst MED2005 is still in development, under the current regulations, Futura Medical are not able to provide samples.
Eroxon® is the registered brand name for the distribution of MED2005, though potential distributors may choose to use other brand names.
MED2005 is the codename used by Futura for the 'locked' formulation for use in ongoing clinical trials. MED2002 is the codename used by Futura for all proprietary formulations of GTN.
Unfortunately, the first European Phase 3 study, FM57 is now fully recruited with headline data expected in December 2019. Whilst the second Phase 3 study, FM59 has not yet started recruitment, it will use centres in USA and Eastern Europe, not the UK.
For further details on the trial, please visit ClinicalTrials.gov.
MED2005 is currently in clinical trials and is not available for purchase. If approved, MED2005 would be released as a prescription-only drug. The product will not be available for sale before 2021
We believe MED2005 has the potential to eventually move to an over the counter product that could be purchased in the chemist.
MED2005 is currently in clinical trials and is not available for purchase.
Futura is currently running a Phase 3 clinical study with headline results available in Dec 2019. Results from this study will help determine the Regulatory submission and approval timeline
For further details on the trial, please visit ClinicalTrials.gov.
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 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.
Current US & EU regulations for generic topical pharmaceutical products provide further protection from competitive products as they typically require a clinical trial programme to show equivalence unlike generic oral drugs which typically only require to show bioequivalence.
It is usual for two Phase 3 studies to be required for filing. However, depending on data from the first Phase III study, we may explore with Regulatory bodies in Europe filing with one Phase 3 study which could occur during 2020. US FDA have been clear that two studies are required, and filing will await results from the second study. Because of this process, the product will not be available for sale before 2021.
As part of the Phase 3 programme, Futura is required by regulators to run an open label extension study. After patients complete their 12 week double blind, they are invited to enter the open label extension study (“OLE”) to assess safety at the highest dose (0.6% GTN). This OLE is a normal requirement of regulators for pharmaceutical products to provide additional reassurance on safety for longer term use of MED2005.
MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In August 2018 Futura filed a Patent Co-operation Treaty (PCT) patent filing which is expected to extend patent life in many geographies to 2037. 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 will adhere to the 2018 priority date through to 2037.
The EU also can provide up to ten year data exclusivity and US up to three years from the date of regulatory approval subject to EU and FDA guidelines.
Completion of the second, confirmatory Phase 3 study, expected to be in Q4 2020, is subject to funding and positive results from “FM57”, the first European Phase 3 trial, the strength of which is expected to influence the magnitude of any financing. In anticipation of this the Board is therefore exploring a number of funding options including non-dilatory and dilatory options and intends to place the Company in a position of strength to continue capitalising on product development and for negotiating any out-licensing agreements for MED2005.
As previously commented following the hand back of rights by both Reckitts 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 of 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 lab work specifically around the permeation characteristics of TPR100 to be conducted. This work is progressing, and we expect Thornton & Ross to respond by the end of February 2020 within the timelines agreed with the MHRA.
CB Derma Techology is a shell company that has been established with backers that have experience in plant derived products. They see this as an interesting new opportunity and are happy to share the development costs at this stage.
The cosmetic market is already significant with the UK, we understand, over £300 million. As a topically applied Pharmaceutical the potential is huge, with currently very little credible scientific research conducted on topical formulations.
DermaSys® provides rapid and targeted local delivery of active pharmaceutical ingredients at therapeutic levels 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.