Today I launched a new project on the Blog, called Cladribine4MS (see the project button).
As you know ProfG was chief investigator of the CLARITY trial, that showed the efficacy of Movectro (oral cladribine) in relapsing MS.
In 2011 Merck terminated their respective programme and the drug was withdrawn from the market across the Globe, despite having been licensed in Australia and Russia.
Later that same year we (excluding ProfG because he was conflicted) began a process to try and develop generic Cladribine for people with relapsing MS. We identified generic companies willing to hold the license, obtained the full CLARITY phase III data set following request to the EMA, and planned a second phase III multi-centre trial to satisfy the UK regulators (MHRA) to support licensing.
In 2014/2015 the National Institute of Health Research indicated that they are not interested in developing anything new for relapsing MS.
In 2015 Merck announced their intention to relaunch Movectro with the EMA.
As a result, we put our attempts to develop generic Cladribine for people with relapsing MS in the UK on hold and went public.
We believe Cladribine has a future as a treatment for pwMS beyond relapsing MS, and are willing to try again.