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Santhera Entered into an Exclusive License and Collaboration Agreement with Catalyst Pharmaceuticals for Vamorolone

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Santhera

Santhera Entered into an Exclusive License and Collaboration Agreement with Catalyst Pharmaceuticals for Vamorolone

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  • Santhera will receive $90M up front incl. $75M in cash & $15M in equity investment, an additional $10M upon US FDA approval of vamorolone in DMD, $26M to pay approval-related regulatory milestones to third parties & sales milestones of ~$105M along with royalties. The transaction is expected to close in Q3’23
  • Catalyst gets exclusive commercialization rights to vamorolone in North America, comprising the US, Canada & Mexico, assuming corresponding third-party royalty obligations on vamorolone sales in NA. Santhera will focus on the EU commercialization of vamorolone in DMD & further development of its clinical pipeline
  • The NDA of vamorolone is under the US FDA’s review in DMD with an anticipated PDUFA data on Oct 2023 while vamorolone could be launched in the EU & US in late 2023 & early in Q1’24, respectively. Both companies will collaborate on joint clinical development & funding of vamorolone for additional indications beyond DMD

Ref: Globenewswire | Image: Santhera

Related News:- Santhera Reports the MAA Submission to the MHRA for Vamorolone to Treat Duchenne Muscular Dystrophy

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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