An innovative cocrystal, obtained by Enantia –based at the Parc Científic de Barcelona– working in collaboration with Esteve R&D, is part of the global partnership recently announced by Esteve and Mundipharma-Purdue. Enantia, a technology based company in the fields of medicinal chemistry, process chemistry and solid forms development, has played a fundamental role in one of the projects included in this partnership: obtaining a single new cocrystal entity composed of two active substances used in pain management.
Esteve designed a series of new therapeutic entity concepts based on different pairs of active substances, and started with Enantia an ambitious project to obtain salts and cocrystals from them. One of the outcomes of this project is E-58425, for which a new entity co-crystal patent was granted in Europe in 2013 and in the USA in 2014, that will rapidly move to Phase III clinical trials thanks to the global partnership of Esteve and Mundipharma-Purdue.
This development comes at an opportune moment when both FDA and EMA have recently given their guidance on the regulatory aspects of pharmaceutical cocrystals, thus paving the way to a new generation of drugs based on the cocrystallization concept.
The agreement between Esteve and Mundipharma-Purdue covers some additional assets that range from preclinical to clinical development and can represent payments to Esteve exceeding $1bn if all development, regulatory and sales milestones are met across all projects.