Lonza contracted to make API for Aurinia's lupus nephritis candidate

By Gareth Macdonald contact

- Last updated on GMT

iStock/jarun011
iStock/jarun011
Lonza has been contracted to the API for a candidate lupus nephritis treatment by Canadian developer Aurinia Pharmaceuticals Inc. 

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.

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