• 07 Nov 2024
• Admin
• News Article

Syndax Pharma & Royalty Pharma Ink $350 Million Royalty Funding Agreement for Niktimvo

Overview

Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company, and Royalty Pharma plc, a largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, announced that Syndax has entered into a $350 million synthetic royalty funding agreement with Royalty Pharma based on US net sales of Niktimvo (axatilimab-csfr).

Words from the CEO: Syndax

• "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. With this significant infusion of capital, we are well positioned to successfully launch two first-in-class medicines and expand their opportunity with additional indications," said Michael A. Metzger, chief executive officer of Syndax. 
• "Royalty Pharma shares our belief that Niktimvo can create significant value as a new treatment option for patients with chronic graft-versus-host disease (GVHD) and recognizes its multi-billion-dollar franchise potential."

Words from the CEO: Royalty Pharma

• "We are excited to partner with Syndax, an innovative oncology company with an exciting pipeline" said Pablo Legorreta, founder and CEO of Royalty Pharma. 
• "Niktimvo is a first-in-class product that has the potential to address the serious and devastating complications associated with chronic GVHD, where there is clear unmet need for additional treatment options. We look forward to Syndax and their partner Incyte launching Niktimvo soon and bringing this important medicine to GVHD patients."

Terms of the Agreement

• Under the terms of the agreement, Syndax received an upfront payment of $350 million in exchange for a 13.8% royalty on US net sales of Niktimvo. 
• Royalty payments to Royalty Pharma will cease upon reaching a multiple of 2.35x.

Advisors for the Agreement

Goldman Sachs & Co. LLC acted as exclusive financial advisor and Cooley LLP acted as legal advisors to Syndax on the transaction. Gibson, Dunn & Crutcher LLP and Dechert LLP acted as legal advisors to Royalty Pharma.

About Niktimvo

• Niktimvo (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the US for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients weighing at least 40 kg (88.2 lbs).
• In the US, Niktimvo will be co-commercialized by Syndax and Incyte. 
• Incyte has exclusive commercialization rights for Niktimvo outside of the US Syndax anticipates that Niktimvo will be launched in the US no later than early first quarter 2025.

Worldwide Rights for Axatilimab

• In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. 
• In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Studies on Axatilimab

• Axatilimab is being studied in frontline combination trials in chronic GVHD – a phase 2 combination trial with ruxolitinib (NCT06388564) is underway and a phase 3 combination trial with steroids is in preparation. 
• Axatilimab is also being studied in an ongoing phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Syndax Pharmaceuticals: - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Company: Royalty Pharma

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies.