Syndax Pharmaceuticals has entered a synthetic royalty funding agreement with Royalty Pharma, focused on US net sales of Niktimvo (axatilimab-csfr), a treatment for chronic graft-versus-host disease (GVHD).
The deal positions Syndax to launch two medicines and pursue further indications.
Syndax has received $350m upfront in return for a 13.8% royalty on Niktimvo’s net US sales.
Royalty payments to Royalty Pharma will cease once they reach 2.35 times the initial amount.
Syndax's financial and legal advisors respectively were Goldman Sachs & Co and Cooley. Gibson, Dunn & Crutcher, and Dechert advised Royalty Pharma.
Syndax CEO Michael Metzger stated: "We expect this transaction to fund us through profitability, while ensuring that we continue to participate in the profits from Niktimvo and retain the upside of its future growth.”
Niktimvo, an anti-colony stimulating factor 1 receptor (CSF-1R) antibody, has received approval in the US for treating chronic GVHD in adult and paediatric patients weighing a minimum of 40kg after at least two previous systemic treatment failures.
In 2016, Syndax obtained exclusive global rights from UCB to develop and commercialise axatilimab.
In September 2021, Syndax and Incyte entered an exclusive global co-development and co-commercialisation licence agreement for axatilimab in chronic GVHD and possible future indications.
Royalty Pharma founder and CEO Pablo Legorreta stated: "We are excited to partner with Syndax, an innovative oncology company with an exciting pipeline.
“We look forward to Syndax and their partner Incyte launching Niktimvo soon and bringing this important medicine to GVHD patients."
Niktimvo will be co-commercialised by Syndax and Incyte in the US, with a launch expected by the first quarter of 2025. Incyte holds exclusive rights to commercialise outside the US.
Axatilimab is currently being evaluated in frontline combination studies for chronic GVHD.
A Phase II trial in combination with ruxolitinib is active, and a Phase III trial with steroids is in the planning stages.
Axatilimab is undergoing a Phase II trial for idiopathic pulmonary fibrosis.
