The common purpose of LEO Pharma’s formulation and development functions are to develop new products and to constantly support the use of existing ones. In collaboration with discovery, we select and promote active drug compounds to drug candidates in preclinical and clinical development processes.
In the preclinical development phase, we assess the risk of the drug candidate to human health prior to, during and after clinical development. We plan, execute and compile non-clinical regulatory safety studies and submissions on development candidates or products in order to support clinical evaluation and marketing of our drugs.
All preclinical safety studies (e.g. toxicology and drug metabolism) are outsourced to specialised contract research organisations (CROs), and we have an established contract research management function handling all contractual steps.
‘Freedom to operate’ analyses are performed to ascertain that no blocking patent rights seem to exist in relation to the drug candidates. We subsequently prepare patent applications covering the new compounds, therapeutic uses thereof, formulations and processes.
Potential new molecules continue to the pharmaceutical formulation phase, in which the choice of ingredients to complement the pharmaceutical substance, the dosage form (e.g. injectable, cream, ointment, tablet, gel, etc.) and the manufacturing methods are designed and tested. The optimum pharmaceutical formulation secures the right absorption of the drug molecule into the human body with a minumum of side-effects.