Ascendis builds up secondary supplier to support global TransCon expansion

Denmark’s Ascendis Pharma completed two Phase III trials of TransCon human growth hormone (hGH) and locked the databases earlier this year, putting it on track to file for approval in the US and Europe in children with growth hormone deficiency next year.

Ascendis, which relies on contract manufacturers, thinks it already has capacity in place to support the anticipated launch of TransCon hGH in the US. However, if all goes to plan, the US will launch will be just one of the operational activities that requires supplies of TransCon hGH.

Talking to investors on a third quarter results conference call, CEO, Jan Mikkelsen, said Ascendis is now “building up the secondary supplier​” to support the global rollout of TransCon hGH.

Ascendis’ decision to build up a secondary supplier while also establishing inventory to support the US launch reflects the scale of its ambitions. Building up the secondary supplier will give Ascendis the capacity to supply TransCon hGH to clinical trials around the world and position it to meet ongoing demand in these markets.

The nature of Ascendis’ operation means it must work with contract manufacturers to secure the TransCon hGH supplies it needs to support its development and commercialization strategy in the US and other markets.

In its annual financial disclosure, Ascendis wrote, “We have limited personnel with experience in manufacturing, and we do not own facilities for manufacturing our products and product candidates for the potential pivotal clinical studies and/or commercial manufacturing of our products and product candidates​.”

Ascendis has previously said there are “only a limited number of companies on a worldwide basis​” with the sort of capacity it needs to manufacture TransCon hGH.

The building up of the secondary supplier and the launch preparations, which Mikkelsen said entail “manufacturing on the highest speed every day​,” are evident in Ascendis’ financial results.

In the third quarter, Ascendis spent €46.3m ($51m) on R&D, up almost 50% over its expenditure in the same period of 2018. Ascendis attributed the increase to “personnel-related costs to support development and manufacturing of TransCon hGH​” and other drugs.

The increase in spending on the production of TransCon hGH stems from the need to manufacture validation batches and build up inventory ahead of the anticipated commercial launch.