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-dilutive and dilutive 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.