Catalyst Pharmaceuticals to license North American rights to vamorolone

Catalyst Pharmaceuticals announced that Catalyst has entered into a definitive agreement with Santhera Pharmaceuticals Holding under which Catalyst 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. The licensing agreement delivers a promising complementary product to Catalyst’s growing rare neuroscience product portfolio and enables further expansion into other rare neurological diseases that address significant unmet medical needs. In addition to the North American rights, which consist of the United States, Canada, and Mexico territories, the transaction provides Catalyst the right of first negotiation for vamorolone in Europe and Japan should Santhera pursue partnership opportunities. Under the terms of the agreement, Catalyst will make a $75 million upfront payment to Santhera and a concurrent strategic equity investment of $15 million into Santhera at an investment price of CHF 0.9477, corresponding to a mutually agreed volume-weighted average price prior to signing, with the equity investment proceeds to be used by Santhera for Phase IV studies in DMD and further development of additional indications. In addition, Santhera may receive future regulatory and commercial milestone payments tied to FDA approval and calendar year sales of vamorolone, as well as commercial royalties. Furthermore, Catalyst and Santhera will enter into a Joint Steering Committee to oversee the development of vamorolone for additional indications beyond DMD. The agreement is structured as an all-cash transaction with no financing contingencies. The transaction is expected to be completed in the third quarter of 2023, subject to customary closing conditions and regulatory clearances in the United States and does not impact Catalyst’s 2023 revenue guidance. The proposed transaction is subject to agreed terms and other closing conditions, including third-party approvals. Catalyst anticipates that upon closing of this transaction, it will be in a position to provide greater details regarding its plans and prospects for vamorolone, as well as the accounting treatment for the transaction.