Around 45% of Schizophrenics relapse each year. At the end of two years it is running at around 75%. At present, the only options are to re-introduce once daily oral therapy, perhaps moving to a new drug, or to introduce long acting injectable therapy (LAIs). LAIs are universally disliked by patients and physicians alike. We see our once weekly opportunity as providing a third option, sitting between the 25% of patients who successfully remain on once daily therapy, and the 5-10% of patients who move onto LAIs. Once weekly oral therapy provides the option for monitoring of dosing to take place in an economically viable environment that can be overseen by the medical team.
The product has strong IP in the US and some selected other territories.
Reformulation work and regulatory requirements are being completed during 2016. Some territories have already been licensed, however, we are looking for partners for the US and Europe in particular, plus other options. During 2017, the project will require around USD4M investment to complete bioequivalence work to prepare data for inclusion in the NDA dossier. Regulatory approval is anticipated towards the end of 2018.
This is a 505b2 regulatory project so does not follow standard rules, if anything it is Phase III as the only requirement will be for a bioequivalence study numbering around 40 subjects.