Tokyo, November 27, 2023 -- Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”), a global pharmaceutical company dedicated to the discovery and development of new treatments for neurodegenerative diseases, today announced that it has established Amylyx Pharmaceuticals Japan K.K. as its Japanese subsidiary. 

Amylyx is headquartered in Cambridge, Massachusetts, USA and has operations globally. The company was co-founded in 2013 by co-CEOs Joshua Cohen and Justin Klee, who were undergraduates at Brown University, while they looked to uncover what causes neurons to die in neurodegenerative disease. Amylyx spent more than 10 years developing their treatment for amyotrophic lateral sclerosis (ALS) in collaboration with the ALS community, including leading doctors, people living with ALS and their caregivers, and advocacy associations. 

In 2022, AMX0035, the Company’s proprietary, oral fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine) was approved for the treatment of ALS in adults in the U.S. and approved with conditions for the treatment of ALS in Canada. AMX0035 is the first and only drug to show an effect on both function and survival in the same trial in ALS. 

Amylyx Pharmaceuticals Japan K.K., a Japanese subsidiary of Amylyx, was established in September 2023. Hiroshi Kowaki has assumed the office of Representative Director of Amylyx Pharmaceuticals Japan K.K., bringing to the role a proven track record of leading businesses to deliver innovative treatment options to people with diseases. Previously, he served in senior level roles at several global pharmaceutical companies including Nippon Boehringer Ingelheim Co., Ltd., AstraZeneca K.K., and Alnylam Japan K.K., 

“Amylyx mission is to one day end the suffering caused by neurodegenerative diseases. We are committed to developing treatments to encourage people with neurodegenerative diseases and their families to live better days and better times,” said Hiroshi Kowaki on the establishment of the Japanese subsidiary. “ALS is a relentlessly progressive disease and affects at least 200,000 people worldwide. Since obtaining approval of our first product for the treatment of ALS in Canada and the U.S., written requests for its priority review, etc. and 10,750 signatures seeking its early approval in Japan have been submitted to the Japanese Ministry of Health, Labour and Welfare by patient advocacy group. We are focusing our efforts on delivering the treatment as quickly as possible in response to the community’s strong desire for immediate access. The establishment of our Japanese subsidiary is the first step towards achieving this goal, and we will continue to work hard to contribute to further improving healthcare in Japan in collaboration with the relevant organizations.” 

We will strive to promptly establish our business structure in Japan, with the aim of obtaining approval of Amylyx’s therapies for the treatment of ALS and other neurodegenerative diseases in Japan as well, which will allow every eligible person seeking treatment options to have access as soon as possible.  

About 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. More than 90% of people with ALS have sporadic disease, showing no clear family history. ALS affects approximately 10,000 people in Japan, approximately 29,000 people in the U.S. and more than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom). People living with ALS have a median survival of approximately two years from diagnosis. ALS is designated as an intractable disease in Japan.

About AMX0035
AMX0035 is an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol (known as ursodoxicoltaurine outside of the U.S.) approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions for the treatment of ALS in Canada. AMX0035 is being studied as an investigational drug in several regions for the potential treatment of ALS and other neurodegenerative diseases. identical. AMX0035 is not approved in Japan for any of these indications.

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