Catalyst Pharma licenses vamorolone rights for DMD from Santhera; $75M upfront + $15M investment

CATALYST PHARMACEUTICALS, INC.

Catalyst pays $75M upfront for exclusive North America license to vamorolone, a DMD drug under FDA review with PDUFA date Oct 26, 2023.
Catalyst also invests $15M in Santhera at CHF 0.9477 (~$1.08) per share for Phase IV and additional indication development.
If approved, Catalyst expects to launch vamorolone in U.S. early Q1 2024; Santhera may receive regulatory/sales milestones and royalties.
Transaction includes right of first negotiation for Europe and Japan if Santhera seeks partnerships; closing expected Q3 2023.
Vamorolone has FDA Fast Track and Orphan Drug designations; met primary endpoint in Phase 2b VISION-DMD study.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.85

CATALYST PHARMACEUTICALS, INC. entered into Investment Agreement with Santhera Pharmaceuticals Holding AG valued at $15,000,000 investment at CHF 0.9477 per share (effective 2023-06-19).

Action: entry
Agreement: equity purchase
Counterparty: Santhera Pharmaceuticals Holding AG
Value: $15,000,000 investment at CHF 0.9477 per share
Effective: 2023-06-19

Exact text from the filing

Additionally, pursuant to the terms of the Investment Agreement, the Company will make a $15 million investment into Santhera at a price of CHF 0.9477 ($1.08 USD) per share, a mutually agreed upon volume-weighted average price prior to signing, with the investment proceeds to be used by Santhera for Phase IV studies in DMD and further development of additional indications.

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Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.85

CATALYST PHARMACEUTICALS, INC. entered into License and Collaboration Agreement with Santhera Pharmaceuticals Holding AG valued at $75,000,000 upfront payment (effective 2023-06-19).

Action: entry
Agreement: license
Counterparty: Santhera Pharmaceuticals Holding AG
Value: $75,000,000 upfront payment
Effective: 2023-06-19

Exact text from the filing

On June 19, 2023, Catalyst Pharmaceuticals, Inc. (the “ Company ”) entered into a License and Collaboration Agreement (the “ License Agreement ”) and an Investment Agreement (the “ Investment Agreement ”, and together with the License Agreement, the “ Agreements ”)) with Santhera Pharmaceuticals Holding AG (“ Santhera ”), under which the Company will enter into an exclusive North America license, manufacturing and supply agreement for Santhera’s investigational product candidate, vamorolone, a dissociative steroid currently under FDA review for the treatment of Duchenne Muscular Dystrophy (“ DMD ”).

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Source: SEC EDGAR

accession 0001193125-23-173863

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