Novartis has been granted an option to obtain exclusive worldwide rights to develop and commercialise Chiasma‘s Transient Permeability Enhancer (TPE), which enables new drugs to be switched from injectable to oral formulations, also resulting in enhanced absorption.
If Novartis exercises the option, the company will assume the global clinical development, manufacturing, regulatory submissions and commercialisation of products containing TPE technology.
Chiasma will then receive payments on the option exercise and on successful completion of certain development and regulatory milestones and be eligible to receive a percentage of any incremental profits.
Chiasma’s chairman and CEO Fredric Price said that the firm’s strategy is to develop its own proprietary products and to enter into arrangements with companies whose important drugs could benefit from the TPE technology.
“Changing the route of administration to oral and evaluating them for new indications will produce new drugs that take advantage of the 505(b)(2) regulatory route in the US and similar regulations in other countries,” Price said.
Chiasma’s TPE technology promotes the delivery of drugs to the GI wall and from there to the liver. It is applicable to macromolecules that at the moment can be administered only by injection. TPE can also be used with small molecules that are already orally available but are poorly absorbed.