Following restructuring of the company in 2012 and partnering in 2013 of the Memogain project with the Canadian Biotechnology company Neurodyn Inc, GalantosPharma now is exclusively focusing on clinical development and market introduction of Memogain. The other drug development projects have been terminated.
As a pro-drug of a market-approved drug, Memogain® should fulfill the requirements for fast-track regulatory approval in the US and Europe. Based on FDA’s 505(b)(2) provisions, such drug candidates can rely in part on data from existing reference drugs and may achieve market approval in as little as 30 months, with significantly fewer clinical trials and the resulting lower costs. Maelicke, CEO of Galantos, has joined Neurodyn as Managing Director Europe for further development and marketing of Memogain.