CAMBRIDGE, Mass.– Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced it has entered into an exclusive license and distribution agreement with Neopharm in which Neopharm will commercialize, subject to regulatory review and approval, AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis (ALS) in Israel, Gaza, West Bank, and the Palestinian Authority.
“This agreement with Neopharm is an important step towards expanding AMX0035’s availability in the EMEA (Europe, Middle East, and Africa) region, if approved,” said Stéphanie Hoffmann-Gendebien, General Manager and Head of EMEA at Amylyx. “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. This decision was based on a number of factors, including the ability to leverage potential approvals in other regions in the Israel Health Ministry’s review process to provide access for eligible people with ALS.”
ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death.
“The addition of AMX0035 to our portfolio and the opportunity to serve the ALS community in Israel and beyond is an honor,” said Efi Shnaidman, General Manager of Neopharm Israel. “We look forward to working with Amylyx to serve people living with ALS who may benefit from this important new treatment option.”
Under the terms of the agreement, Neopharm will receive exclusive rights to commercialize AMX0035 in the covered territory and will be responsible for all regulatory filings and obligations required for the registration and reimbursement of AMX0035.
