Nxera Pharma Licenses Japan and Select Asia-Pacific Rights to Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals
Globenewswire·2026-01-08 07:48

Core Viewpoint - Nxera Pharma has entered an exclusive licensing agreement with Santhera Pharmaceuticals for the development, manufacturing, and commercialization of vamorolone for Duchenne Muscular Dystrophy (DMD) in Japan, South Korea, Australia, and New Zealand [1][5]. Group 1: Licensing Agreement Details - Nxera will be responsible for obtaining regulatory approval for vamorolone in the licensed territories, including conducting necessary clinical trials and leading commercialization and manufacturing activities [3]. - The agreement includes an upfront payment of USD 40 million to Santhera, consisting of USD 30 million in cash and USD 10 million as a strategic equity investment [6]. - Santhera is eligible for additional sales and regulatory milestone payments of up to USD 165 million, along with tiered royalties starting in the low teens on net sales of vamorolone in the licensed territories [6]. Group 2: Product and Market Potential - Vamorolone is positioned as a late-stage development candidate that addresses significant unmet needs for DMD patients in Japan and the Asia-Pacific region [2]. - The product is already approved and marketed as AGAMREE® in the US, EU, UK, and China, highlighting its established presence in the market [1][8]. - Vamorolone's differentiated safety and efficacy profile has the potential to change the standard of care for DMD by allowing early use, full dosing, and long-term treatment, addressing limitations of existing steroid therapies [4][8]. Group 3: Company Strategy and Vision - The transaction aligns with Nxera's mission to bring innovative medicines to patients in Japan and the APAC region, supporting its 2030 vision to build a high-growth, highly profitable biopharma company [5][8]. - Nxera's team has significant prior development and manufacturing experience with vamorolone, enhancing its capability to commercialize the product effectively in the targeted markets [3][5].