Immunohistochemistry specimen of Amyotrophic lateral sclerosis (ALS-TDP) showing TDP-43-positive inclusions (brown) in motor neurons. Credit: Jensflorian / Wikimedia.

Amylyx Pharmaceuticals and Neopharm have signed a licence and distribution agreement to commercialise AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).

Neopharm will commercialise the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercialising the therapy in the covered territory.

Additionally, Neopharm will handle all obligations and regulatory filings that are needed for AMX0035 registration and reimbursement.

Amylyx Pharmaceuticals EMEA general manager and head Stéphanie Hoffmann-Gendebien said: “This agreement with Neopharm is an important step towards expanding AMX0035’s availability in the EMEA (Europe, Middle East, and Africa) region if approved.

“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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.”

AMX0035 received approval in the US as Relyvrio (sodium phenylbutyrate and taurursodiol) to treat ALS in adult patients.

In Canada, it is approved with conditions such as Albrioza (sodium phenylbutyrate and ursodoxicoltaurine).

The European Medicines Agency (EMA) is also reviewing the Marketing Authorization Application submitted by Amylyx for AMX0035 to treat ALS patients in Europe.

Death of motor neurons in the brain and spinal cord leads to the progressive and fatal neurodegenerative disorder ALS.