Santhera Pharmaceuticals has entered an exclusive licensing agreement with Nxera Pharma for Agamree (Vamorolone) to treat Duchenne muscular dystrophy (DMD) in Australia, Japan, New Zealand, and South Korea.

Agamree is a new drug that operates by attaching to the same receptor as glucocorticoids while altering its downstream activity.

The agreement involves the development, manufacturing and commercialisation of Agamree and is valued at up to $205m plus royalties.

Under the deal, Santhera will be eligible for $40m in upfront payment from Nxera. Of this, $30m will be paid in cash while $10m will be provided as an equity investment in Santhera through the purchase of approximately 530,000 shares.

Santhera will also receive up to $165m in sales and regulatory milestone payments, along with tiered royalties in the double-digit range on Agamere's net sales within the licensed countries.

Nxera will secure regulatory approval for Agamree in these markets. Its responsibilities include leading all related commercial and production tasks, conducting a registrational bridging clinical study for the regions covered by the agreement.

Santhera CEO Dario Eklund said: “This strategic partnership represents a significant milestone in our mission to expand global access to Agamree and bring meaningful new treatment options to patients with DMD worldwide.

“Nxera's deep expertise and established infrastructure in Japan and across the wider APAC region, as well as prior experience of vamorolone, make them an ideal partner to unlock the full commercial and clinical potential of Agamree in these markets and accelerate access for patients with DMD.”

In October 2025, Health Canada approved Agamree from Santhera for the treatment of DMD in individuals aged four years and older.