Santhera Licenses AGAMREE to Nxera in Key Asia-Pacific Markets

Santhera Pharmaceuticals has signed an exclusive licensing agreement with Nxera Pharma UK to develop, manufacture, and commercialize AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in Japan, South Korea, Australia, and New Zealand. The deal marks a major step in Santhera’s strategy to expand global access to its flagship therapy while leveraging Nxera’s established presence and expertise across the Asia-Pacific region.

Under the terms of the agreement, Santhera will receive an upfront payment of USD 40 million, comprising USD 30 million in cash and a USD 10 million equity investment in the company by Nxera. The equity component will be completed through the purchase of approximately 530,000 Santhera shares at a price of CHF 14.91 per share, representing a 20% premium to Santhera’s 30-day volume-weighted average share price prior to the announcement. The newly issued shares will be subject to a customary lock-up period following closing.

In addition to the upfront consideration, Santhera is eligible to receive up to USD 165 million in regulatory and sales-based milestone payments. The company will also earn double-digit, tiered royalties on net sales of AGAMREE across the licensed territories. Taken together, the agreement is valued at up to USD 205 million, excluding royalties, reflecting the commercial potential of AGAMREE in the Asia-Pacific region.

Nxera will assume responsibility for securing regulatory approvals in the licensed markets, including conducting a registrational bridging clinical study where required. The company will also lead commercial and manufacturing activities in the region. The partnership draws on Nxera’s strong track record in specialty and rare disease medicines, particularly in Japan, where significant unmet medical need remains for patients living with Duchenne muscular dystrophy.

Nxera’s capabilities are further strengthened by its prior experience with vamorolone. Through its 2023 acquisition of Idorsia’s Japan and APAC business, Nxera gained development and manufacturing expertise related to the drug, with members of the former Idorsia team in Basel having worked on earlier stages of vamorolone’s development.

Santhera Chief Executive Officer Dario Eklund said the agreement represents a significant milestone in the company’s mission to bring AGAMREE to patients worldwide. He emphasized that Nxera’s regional infrastructure, regulatory know-how, and familiarity with vamorolone position the partner to accelerate patient access in these important markets.

Christopher Cargill, President and Chief Executive Officer of Nxera, said the company is eager to introduce AGAMREE to DMD patients across the licensed territories. He highlighted the therapy’s differentiated safety and efficacy profile, noting its potential to change the standard of care by enabling earlier use, full dosing, and long-term treatment compared with traditional steroid therapies currently used in the region.

The deal underscores growing momentum around AGAMREE as a new treatment option for Duchenne muscular dystrophy and reflects continued industry investment in addressing rare neuromuscular diseases globally.