Nxera Pharma Licenses Japan and Select Asia-Pacific Rights to Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals

Executive Summary

• Nxera Pharma entered an exclusive licensing agreement with Santhera to develop, manufacture and commercialize vamorolone (AGAMREE®) for Duchenne Muscular Dystrophy in Japan, South Korea, Australia and New Zealand.
• The transaction includes a USD 40 million upfront payment (USD 30 M cash + USD 10 M strategic equity investment) plus potential milestone payments up to USD 165 M and tier‑tiered royalties in the low teens on net sales.
• Vamorolone’s five‑year safety data show reduced vertebral fractures, lower cataract incidence and maintained normal growth, positioning it as a potentially superior alternative to existing corticosteroids for DMD patients in APAC.

Key Details

• Upfront Consideration: USD 40 million total – USD 30 million cash, USD 10 million equity investment in Santhera.
• Milestone Payments: Up to USD 165 million payable upon achievement of sales and regulatory milestones.
• Royalties: Tiered royalties beginning in the low‑teens percent on net sales of vamorolone within the licensed territories.
• Territories Covered: Japan, South Korea, Australia, New Zealand.
• Nxera Responsibilities: Obtain regulatory approvals, conduct required clinical trials, lead manufacturing and commercialization activities in the licensed regions.
• Strategic Rationale: Adds a late‑stage, rare‑disease product with differentiated safety/efficacy to Nxera’s portfolio (which already includes PIVLAZ™ and QUVIVIQ™), supporting its 2030 vision of building a high‑growth, highly profitable Japanese biopharma company.
• Clinical Background: Vamorolone approved as AGAMREE® in US, EU, UK, China; pivotal VISION‑DMD study met primary endpoint (TTSTAND velocity, p = 0.002). Five‑year GUARDIAN data demonstrate improved safety vs. conventional corticosteroids.
• Quotes:
• Christopher Cargill, President & CEO, Nxera: “Vamorolone’s differentiated safety and efficacy profile has the potential to fundamentally change the standard of care…”.
• Dario Eklund, CEO, Santhera: “This partnership represents a significant milestone … to expand global access to AGAMREE®.”

Notable Quotes

• “We are excited to partner with Santhera to bring vamorolone to DMD patients in Japan, South Korea, Australia and New Zealand. Vamorolone’s differentiated safety and efficacy profile has the potential to fundamentally change the standard of care…” – Christopher Cargill, President & CEO, Nxera Pharma.

• “Nxera's deep expertise … make them an ideal partner to unlock the full commercial and clinical potential of AGAMREE® (vamorolone) in these markets…” – Dario Eklund, CEO, Santhera Pharmaceuticals.