- Amylyx Pharmaceuticals ( NASDAQ: AMLX ) and Neopharm have signed an agreement to commercialize the former’s FDA-approved treatment for amyotrophic lateral sclerosis (ALS) AMX0035 in regions including Israel.
- According to the deal, Amylyx ( AMLX ) will give exclusive rights for Neopharm to commercialize the treatment in Israel, West Bank, Gaza, and the Palestinian Authority.
- The Israeli firm will handle the activities required for AMX0035 registration and reimbursement in the covered territory and plans to sell an oral, fixed-dose form of the therapy there, pending regulatory review and clearance.
- “Our team remains steadfast in our mission to help every eligible person living with ALS gain access to AMX0035, and working with the right partners, such as Neopharm, will help us to reach that goal as quickly and efficiently as possible ,” Amylyx’s ( AMLX ) EMEA general manager and head Stéphanie Hoffmann-Gendebien said.
- In September, the FDA approved AMX0035 as Relyvrio for adults with ALS after an AdCom panel of the regulator backed its use, reversing an earlier decision.
- However, Seeking Alpha contributor Avisol Capital Partners says its impact on the company’s future “remains unpredictable.”
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Amylyx in pact to commercialize ALS therapy in Israel