Catalyst in licensing deal with Santhera for Duchenne candidate

• Catalyst Pharmaceuticals (NASDAQ:CPRX) announced Tuesday a licensing agreement with Switzerland-based Santhera Pharmaceuticals Holding (OTC:SPHDF) to obtain North American rights for vamorolone, a candidate for rare neuromuscular disorder Duchenne Muscular Dystrophy (“DMD”).
• Santhera’s new drug application for vamorolone is currently under FDA review, with a target action date of October 26, 2023.
• Per the terms of the exclusive deal, Catalyst (CPRX) will receive rights to commercialize vamorolone in the U.S., Canada, and Mexico. The company will also obtain initial negotiation rights for vamorolone if Santhera seeks partnerships to develop the treatment for European and Japanese markets.
• In return, Santhera will be entitled to $75M upfront and an equity investment of $15M from Catalyst (CPRX). There will be additional regulatory and commercial milestone payments as well as royalties linked to vamorolone sales.
• The transaction is expected to close in Q3 2023, and Catalyst (CPRX) intends to launch vamorolone for DMD in Q1 2024, subject to FDA approval.

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