Santhera Pharmaceuticals (SIX:SANN) executive vice president for corporate planning and business development Andreas Missy talked with Proactive's Stephen Gunnion about a major licensing agreement signed with Nxera for the development, manufacturing, and commercialisation of AGAMREE in Japan, South Korea, Australia, and New Zealand.
Missy explained that AGAMREE, Santhera’s treatment for Duchenne Muscular Dystrophy (DMD), is already available in the US, EU, UK, Canada, and China. The deal with Nxera is valued at up to $205 million, including a $40 million upfront payment - $30 million in cash and $10 million as an equity investment priced at a 20% premium. Santhera is also eligible for up to $165 million in regulatory and sales milestones, plus double-digit tiered royalties on net sales.
“Nxera is a technology-powered biopharma company with the ability to execute, as shown by its commercialisation of PIVLAZ,” said Missy, citing the company’s regional infrastructure and experience from its acquisition of Idorsia’s APAC operations.
Missy noted a bridging clinical study may be required in Japan, and Nxera will be responsible for regulatory filings and regional manufacturing setup. He added that Japan alone represents a DMD patient population of over 2,000, with a high percentage already treated with steroids.
Missy also outlined Santhera’s broader global expansion strategy, which includes recent deals in Turkey, the GCC region, India, and Russia, and plans for further licensing in markets like Latin America.
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