Amylyx Pharmaceuticals Inc.

08/24/2023 | Press release | Distributed by Public on 08/24/2023 08:16

Government of Manitoba to Publicly Reimburse ALBRIOZA™ for the Treatment of ALS

TORONTO, August 24, 2023 / Amylyx Pharmaceuticals Canada announced today that the Company has entered into a Product Listing Agreement with Manitoba for the public reimbursement of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) through the Manitoba Pharmacare drug benefit program effective August 24, 2023, for the treatment of amyotrophic lateral sclerosis (ALS). In the CENTAUR clinical trial, ALBRIOZA demonstrated a significant reduction in disease progression and functional decline among individuals diagnosed with ALS.i This encouraging result offers the possibility of extending their period of functional independence, granting them invaluable additional time.

"We commend the government of Manitoba for its decision to offer public coverage for this treatment," said Diana Rasmussen, Executive Director of the ALS Society of Manitoba. "As this fatal disease progresses so quickly, access to approved treatment options represents a lifeline of hope and dignity for those battling this devastating disease."

Amylyx is continuing to work with the other provincial, territorial, and federal drug plans to have ALBRIOZA listed on public formularies across the country.

"We extend our gratitude to the government of Manitoba for their collaboration and support in providing public coverage for ALBRIOZA, enabling timely treatment for Manitobans living with ALS," said Chris Aiello, General Manager and Head of Canada at Amylyx. "Acknowledging the speed at which this fatal disease progresses, our mission is to secure fair access to eligible Canadians, regardless of their location. We are actively collaborating with other provincial, territorial, and federal drug plans to accelerate the process and turn this goal into a reality as quickly as possible."

As the disease progresses, people living with ALS will lose their mobility, their ability to feed and clothe themselves, to speak with and hug their loved ones, and eventually the ability to swallow and even breathe.

"ALS is a rapidly progressive neurological disease which causes progressive physical decline in the affected patients. Hence, access to medications that potentially can slow the progressive course of ALS is crucial," said Dr. Davood Fathi, Neurologist, Director ALS/MND Clinic in Winnipeg, Assistant Professor, University of Manitoba. "Myself and other neurologist colleagues working with the ALS community are hopeful to see ALBRIOZA listed on public drug plans Canada-wide."

About ALS

ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord with a median life expectancy of two years from diagnosis.ii Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis and eventually, death.

About ALBRIOZA™

ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine), previously known as AMX0035, is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada. It is approved to treat ALS in adults in the U.S. as RELYVRIO®. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases. The formulation of RELYVRIO, ALBRIOZA, and AMX0035 are identical.

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative disease community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit amylyx.ca and follow us on LinkedIn and Twitter.

For media inquiries, please contact the Amylyx Media Team at +1 (857) 799-7274 or [email protected].

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i Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis - PubMed (nih.gov)

ii Survival and epidemiology of amyotrophic lateral sclerosis (ALS) cases in the Chicago and Detroit metropolitan cohort: incident cases 2009-2011 and survival through 2018