Trending...
- Awake! Ye Sisters All: Sisterhood in Boston's Women's Voter Registers
- Boston: Inaugural Cohort of Young Black Leaders Announced
- See what our March partners are offering now!
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
About AMX0035
AMX0035 is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. as RELYVRIO™ (sodium phenylbutyrate and taurursodiol) and approved with conditions in Canada as ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine). Additionally, the European Medicines Agency (EMA) is reviewing the Company's Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases.
More on Boston Chron
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.com and follow us on LinkedIn and Twitter. For investors, please visit investors.amylyx.com.
About Neopharm
Established in 1941, Neopharm is one of Israel's leading providers of innovative integrated solutions across the pharmaceutical, medical and healthcare markets. Neopharm focuses on the sale and marketing of novel groundbreaking specialty and orphan medications as well as home healthcare services in Israel via partnerships with the world's leading multinational bio-pharma companies. Neopharm is the partner-of-choice and one-stop-shop for multinational bio-pharma companies seeking to enter or expand their business in the Israeli pharmaceutical, medical and biotechnology markets and is proud of its best-in-class platform, reputation and track-record of success for launching and marketing groundbreaking novel therapies in Israel.
More on Boston Chron
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding plans and expectations related to the Company's exclusive distribution agreement with Neopharm; expectations regarding regulatory approvals and the ability to leverage regulatory approvals in other regions; and expectations regarding our longer-term strategy. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities, Amylyx' ability to execute on its commercial and regulatory strategy, regulatory developments, expectations regarding the timing of regulatory review of AMX0035 for the treatment of ALS, Amylyx' ability to fund operations, and the impact that the ongoing COVID-19 pandemic, global macroeconomic uncertainty and geopolitical instability will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contacts
Media
Amylyx Media Team
+1 (857) 799-7274
amylyxmediateam@amylyx.com
Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
+1 (857) 320-6244
Investors@amylyx.com
"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.
About AMX0035
AMX0035 is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. as RELYVRIO™ (sodium phenylbutyrate and taurursodiol) and approved with conditions in Canada as ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine). Additionally, the European Medicines Agency (EMA) is reviewing the Company's Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases.
More on Boston Chron
- Boston: March 2023: Latest Updates from the Mayor's Office of Housing
- Boston: April Allston/Brighton Community Center Study Meeting
- Boston: Mayor Wu Launches $750,000 Grant Fund to Support Growth of Businesses and Access to City Contracts
- Mayor Wu Announces $4 Million Investment to Expand Boston's Tuition Free Community College Program
- Boston: Meet the Fine Arts Work Center Scholarship Recipients
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.com and follow us on LinkedIn and Twitter. For investors, please visit investors.amylyx.com.
About Neopharm
Established in 1941, Neopharm is one of Israel's leading providers of innovative integrated solutions across the pharmaceutical, medical and healthcare markets. Neopharm focuses on the sale and marketing of novel groundbreaking specialty and orphan medications as well as home healthcare services in Israel via partnerships with the world's leading multinational bio-pharma companies. Neopharm is the partner-of-choice and one-stop-shop for multinational bio-pharma companies seeking to enter or expand their business in the Israeli pharmaceutical, medical and biotechnology markets and is proud of its best-in-class platform, reputation and track-record of success for launching and marketing groundbreaking novel therapies in Israel.
More on Boston Chron
- Boston: The Mary Eliza Project: Ward 3 Voter Records Now Available
- Boston AIR Spotlight: Ellice Patterson and Boston Transportation Department
- Mayor Wu Announces Applications Open for the 2023-2024 SPARK Boston Council
- Awake! Ye Sisters All: Sisterhood in Boston's Women's Voter Registers
- Mayor Wu Announces Events in Remembrance of the 2013 Boston Marathon
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding plans and expectations related to the Company's exclusive distribution agreement with Neopharm; expectations regarding regulatory approvals and the ability to leverage regulatory approvals in other regions; and expectations regarding our longer-term strategy. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities, Amylyx' ability to execute on its commercial and regulatory strategy, regulatory developments, expectations regarding the timing of regulatory review of AMX0035 for the treatment of ALS, Amylyx' ability to fund operations, and the impact that the ongoing COVID-19 pandemic, global macroeconomic uncertainty and geopolitical instability will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contacts
Media
Amylyx Media Team
+1 (857) 799-7274
amylyxmediateam@amylyx.com
Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
+1 (857) 320-6244
Investors@amylyx.com
Filed Under: Business
0 Comments
Latest on Boston Chron
- Olga Torres Named Top Advisor by Foreign Investment Watch
- Benchmark International Scsflly Fclitd The Trnstn Btw Bagel King Wholesale and Austin Circle Partner
- Attorney Steve Hilst Named Partner at Bisnar Chase
- 26 Provider Fairview Community Health Center Transitions to Intelligent eClinicalWorks Cloud
- New xBit Digital Case Management Feature Saves Examiners Hours of Required Report Upload Time
- Knobull Helps Professionals Fight Personal Isolation At School & Work
- IntellaTriage Hires New Vice President of Technology
- ASI Hosts 2023 Executive Summit for Partners and Announces Annual Award Winners
- Avidity Biosciences Provides Regulatory Update on AOC 1001 for Myotonic Dystrophy Type 1 and Plans to Present Top-line Data from Phase 1/2 MARINA™ Trial at AAN Annual Meeting
- Namify's Website Name Generator: The Ultimate Solution for Finding Your Perfect Website Name
- NFL Quarterback Lamar Jackson & Lamar Jackson Entertainment Presents Roll With The Punches 'It's Okay Knot To Be Okay' Black Tie & Sneaker Gala
- Tuani Lash Brings Luxury Lash Services and Joy to Oakland's Homeless Community
- Massachusetts: Governor Healey Signs $389 Million Supplemental Budget
- Sherry Orel Joins STS Capital Partners
- Boston: City Council Recognizes International Cape Verdean Women's Day
- American Equus Expands Product Line with Suomy Riding Helmets
- "Third Thursdays": w/former Ornette Coleman colleagues joining host Dave Bryant in April & May 2023
- Arbutus Medical Launches TrakPak® with QuikBow™ to Improve Skeletal Traction, Announces Successful Cases
- Axis Communications Unveils New Devices at ISC West, Underscoring Its Commitment to Deep Learning and Advanced Analytics
- Healey-Driscoll Administration Announces Funding for 450 New Affordable Housing Units Across Massachusetts