Santhera And Nxera Partner To Advance Vamorolone For Duchenne Muscular Dystrophy In Asia-Pacific

Nxera Pharma has signed an exclusive licensing agreement with Santhera Pharmaceuticals to develop, manufacture, and commercialize vamorolone for the treatment of Duchenne Muscular Dystrophy (DMD) across Japan, South Korea, Australia, and New Zealand. Vamorolone is already approved and sold as AGAMREE® in major markets, including the US, EU, UK, and China for treating this rare inherited neuromuscular disorder.

Christopher Cargill, President and Chief Executive Officer of Nxera, commented: “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 by enabling early use, full dosing, and long-term treatment, addressing critical limitations of existing steroid therapies currently used in the region. “Furthermore, the transaction expands our portfolio of late- and commercial-stage products for Japan/APAC and advances our mission to bring innovative medicines to patients in these important regions in line with our 2030 vision to build high-growth, highly profitable Japanese biopharma company.”

With the inclusion of vamorolone, Nxera strengthens its portfolio of innovative therapies for rare and specialty diseases. The drug represents a late-stage asset with the potential to address significant unmet medical needs among DMD patients in Japan and the wider Asia-Pacific region. Nxera’s existing portfolio includes PIVLAZ™ and QUVIVIQ™, both approved in Japan and progressing through commercialization in other APAC markets.

Under the agreement, Nxera will take full responsibility for securing regulatory approvals in the licensed territories. This includes managing clinical trials where required, as well as overseeing manufacturing and commercial launch activities. The partnership builds on Nxera’s strong regulatory and commercial track record across the APAC region, particularly in Japan.

Dario Eklund, Chief Executive Officer of Santhera, added: “This strategic partnership represents a significant milestone in our mission to expand global access to AGAMREE® (vamorolone) 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® (vamorolone) in these markets and accelerate access for patients with DMD.”

Nxera also brings hands-on experience with vamorolone through its 2023 acquisition of Idorsia’s Japan and APAC business. This background is expected to accelerate development timelines and support efficient manufacturing and market access for the therapy across the licensed regions.