Amylyx Pharmaceuticals Appoints Masako Nakamura to General Manager and Head of International Markets - Asia Pacific and Latin America

Rhea-AI Summary

Amylyx Pharmaceuticals has appointed Masako Nakamura as General Manager and Head of International Markets for Asia Pacific and Latin America. With over 30 years of experience in the biopharmaceutical industry, she aims to enhance the global reach of AMX0035, also known as RELYVRIO in the U.S. and ALBRIOZA in Canada. The company is progressing with regulatory discussions in Europe following a strong commercial launch in the U.S. and Canada. Nakamura's leadership is expected to advance Amylyx's mission of delivering innovative therapies for amyotrophic lateral sclerosis (ALS) and addressing unmet needs in neurodegenerative diseases.

Positive

• Appointment of Masako Nakamura as General Manager may strengthen leadership.
• Nakamura's extensive experience in commercializing therapies is beneficial.
• Strong start in U.S. and Canada positions the company favorably.

Negative

• Regulatory approval in Europe is still pending, introducing uncertainty.

• Ms. Nakamura brings over 30 years of leadership in commercializing therapies internationally, including most recently as SVP, Head of Asia at Alnylam Pharmaceuticals
• Joins Amylyx as a key leader with the goal of bringing AMX0035 to as many people who may benefit around the world as possible

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the appointment of Masako Nakamura to General Manager and Head of International Markets - Asia Pacific and Latin America. Ms. Nakamura brings 30 years of commercial, general management, and operational leadership experience in the biopharmaceutical industry with a strong focus on introducing rare disease therapies worldwide across multiple therapeutic areas.

“With our commercial launch off to a strong start in the U.S. and Canada and with regulatory discussions underway in Europe, we are making great progress towards our goal of delivering AMX0035, also known as ALBRIOZA and RELYVRIO, to as many people with ALS as possible,” said Margaret Olinger, Chief Commercial Officer of Amylyx. “But we know there are many more people around the world who may benefit from a potential new treatment option. We are so excited that Ms. Nakamura has joined us to lead those efforts internationally in Asia Pacific and Latin America, bringing with her decades of experience and leadership in bringing important treatments to people with rare diseases.”

Prior to joining Amylyx, Ms. Nakamura was Senior Vice President, Head of Asia at Alnylam Pharmaceuticals, responsible for the strategic vision, direction, and implementation of the Company’s operations in Asia, starting with Japan. Prior to Alnylam, Ms. Nakamura held several international and global senior leadership roles at Aegerion Pharmaceuticals, Genzyme, and Genetics Institute. Throughout her tenure, she has successfully introduced and provided access to more than 20 innovative and transformative medicines within the rare disease community globally.

“Time is so precious for people with ALS and neurodegenerative diseases. I am thrilled to be joining Amylyx at this important time to expand Amylyx’ global footprint and address the unmet needs of people living with ALS and neurodegenerative diseases internationally in Asia Pacific and Latin America,” said Ms. Nakamura.

About RELYVRIO^® (previously known as AMX0035 in the U.S.)

RELYVRIO^® (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada. 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.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR RELYVRIO (sodium phenylbutyrate/taurursodiol), for oral suspension

INDICATION

RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

IMPORTANT SAFETY INFORMATION

Before you receive RELYVRIO, tell your doctor about all of your medical conditions, including if you:

• have pancreas, liver, or intestinal problems.
• have heart failure, including congestive heart failure.
• have high blood pressure.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if RELYVRIO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if RELYVRIO passes into your breast milk. You and your doctor should decide the best way to feed your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

RELYVRIO may affect the way other medicines work, and other medicines may affect how RELYVRIO works.

What are the possible side effects of RELYVRIO?

RELYVRIO may cause serious side effects, including:

• Changes in bile acid levels. RELYVRIO may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your doctor should monitor you for these side effects. Some disorders of the pancreas, bile ducts, or intestines may also make it harder to absorb RELYVRIO.
• Salt (sodium) retention. RELYVRIO contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or kidney problems, limit the amount of salt you eat and drink. Talk to your doctor about the total amount of daily salt that is right for you. Your doctor will monitor you for signs and symptoms of salt retention during your treatment with RELYVRIO.

The most common side effects of RELYVRIO include:

• Diarrhea
• Abdominal pain
• Nausea
• Upper respiratory tract infection

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELYVRIO. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please click here to read the full Prescribing Information for RELYVRIO^®.

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.

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 the potential approval of AMX0035 for the treatment of ALS in countries other than the United States and Canada; the potential of AMX0035 as a treatment for ALS globally and the Company’s plans to explore the use of AMX0035 for other neurodegenerative diseases; 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: Amylyx’ ability to fund operations, the success, cost, and timing of Amylyx’ program development activities, Amylyx’ ability to execute on its commercial and regulatory strategy, the possibility that Amylyx may not obtain additional or maintain regulatory approvals for AMX0035, expectations regarding the timing of EMA review of AMX0035 for the treatment of ALS, the possibility that Amylyx may fail to achieve degree of market acceptance needed to become profitable, healthcare insurance coverage and reimbursement may be limited or unavailable for RELYVRIO in the U.S. and ALBRIOZA in Canada, competitive products may reduce or eliminate the commercial opportunity for AMX0035, Amylyx’ reliance on third parties, including to conduct clinical trials and manufacture products, and ongoing impacts of the COVID-19 pandemic on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the fiscal year ended December 31, 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, subject to any obligations under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230420005326/en/

Media

Amylyx Media Team

+1 (857) 799-7274

amylyxmediateam@amylyx.com



Investors

Lindsey Allen

Amylyx Pharmaceuticals, Inc.

+1 (857) 320-6244

Investors@amylyx.com

Source: Amylyx Pharmaceuticals, Inc.

FAQ

Who is Masako Nakamura and what is her role at Amylyx?

Masako Nakamura has been appointed as General Manager and Head of International Markets at Amylyx, focusing on Asia Pacific and Latin America.

What is the significance of AMX0035 for Amylyx?

AMX0035, known as RELYVRIO in the U.S., is a critical treatment for ALS and aims to expand its reach globally.

What is the current status of AMX0035 regulatory approvals?

AMX0035 has been launched in the U.S. and Canada, with ongoing regulatory discussions in Europe.

How might Nakamura's appointment impact Amylyx's global strategy?

Nakamura's extensive background in introducing therapies can enhance Amylyx's efforts to expand its international market presence.