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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.
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.