Lonza contracted to make API for Aurinia's lupus nephritis candidate
The deal – financial terms of which were not disclosed – will see Lonza make supplies of the active pharmaceutical ingredient (API) voclosporin for a Phase III trial that is due to start in the first half of 2017.
The contract includes an option that would see Lonza supply the active ingredient on an exclusive basis for a period of 20 years if Aurinia wins approval for the drug.
A Lonza spokesman told us the API will be produced at the firm's facility in Visp, Switzerland.
Background
Voclosporin is an immunosuppressant that inhibits calcineurin, an enzyme that activates T cells that is also known to play a role in damaging autoimmune diseases like lupus.
The drug was discovered by Canadian Isotechnika Pharma.
Isotechnika licensed voclosporin – then known as ISAtx247 - to Roche in 2002 in deal focused on developing the drug for the prevention of organ rejection after a transplant.
However, the Swiss drug handed back rights to the drug a few years later citing a change in development priorities.
While the partnership did not generate any products, Roche’s involvement prompted revision of the voclosporin manufacturing process to ensure that a more bioavailable version of the API was produced.
Other licensees
Isotechnika also licensed voclosporin to Lux Biosciences GmbH. However, Lux abandoned efforts to develop it as a treatment for the eye disorder uveitis in 2011 after being unable to demonstrate efficacy.
In 2013, Isotechnika merged with Vifor spin-out firm Aurinia to focus on developing voclosporin for nephrology indications.
