- Dr. Bedrosian brings to Amylyx nearly 30 years of leadership
in clinical research, development, and advancing pipeline programs
into commercialized global products including as CMO at Ultragenyx,
Alexion, and ARIAD Pharmaceuticals
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the
“Company”) today announced the appointment of Camille L. Bedrosian,
MD, as Chief Medical Officer (“CMO”). In this role, Dr. Bedrosian
will lead global functions in medical affairs, regulatory, safety
and pharmacovigilance, biometrics, clinical development, and
clinical operations. Dr. Bedrosian brings nearly 30 years of
experience addressing unmet medical needs for people with rare and
serious diseases through successful clinical and translational
research programs, including as CMO at Ultragenyx Pharmaceutical
Inc. (“Ultragenyx”), Alexion Pharmaceuticals, Inc. (“Alexion”), and
ARIAD Pharmaceuticals Inc. (“ARIAD”). Amylyx’ current CMO, Patrick
Yeramian, MD, MBA, will stay on as an advisor through the end of
the year and will then transition into retirement, as announced in
December 2022.
“We are thrilled to have Dr. Bedrosian join us on our mission to
end the suffering caused by neurodegenerative diseases and to help
usher in a new era of innovation for the communities we are
serving,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx.
“Dr. Bedrosian brings extensive experience having developed
multiple successful medicines and facilitated global access to
them, and her experience will be invaluable at Amylyx as we advance
on our mission.”
Prior to joining Amylyx, Dr. Bedrosian served most of her nearly
six years at Ultragenyx as the Executive Vice President and CMO
where she was responsible for leading drug development programs and
supporting translational research programs. During her time, she
helped Ultragenyx grow and greatly advance its many pipeline
programs in rare genetic diseases to their current and exciting
pivotal stages. While CMO for Alexion, she led the development of
drugs and drug candidates, including those designed to address
devastating rare diseases caused by defects in the complement
system for people with paroxysmal nocturnal hemoglobinuria and
atypical hemolytic uremic syndrome. Prior to Alexion, Dr. Bedrosian
was CMO for ARIAD, where she led drug development and built the
clinical organization. She serves as a Member of the MIT
Corporation Visiting Committee for the Department of Biology. She
also currently serves on the board of directors of Crinetics
Pharmaceuticals, Inc. as well as Rhythm Pharmaceuticals, Inc.
“The team at Amylyx has made great strides in redefining how ALS
is treated with the launch of RELYVRIO and ALBRIOZA, the first and
only drug to show a benefit on both function and survival in people
living with ALS in a single clinical trial. I’m excited to join
Amylyx and contribute to bringing innovative, new treatment options
to individuals and communities suffering from neurodegenerative
diseases. I look forward to working with this talented team to
further Amylyx’ leadership in ALS as well as in broader
neurodegenerative diseases on behalf of people living with these
conditions,” said Dr. Bedrosian.
“We also want to thank our longtime Chief Medical Officer, Dr.
Patrick Yeramian, for his many years of dedication and commitment
to building Amylyx into the successful company it is today. Dr.
Yeramian was critical in the development of RELYVRIO and ALBRIOZA
and the Health Canada conditional approval and FDA approval as well
as building a world-class medical organization, and Amylyx would
not be what it is today without his leadership,” said Mr. Cohen and
Mr. Klee, Co-CEOs of Amylyx.
About RELYVRIO®/ALBRIOZA™/AMX0035
RELYVRIO® (also known as AMX0035), an oral, fixed-dose
combination of sodium phenylbutyrate and taurursodiol (known as
ursodoxicoltaurine outside of the U.S.), is 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. AMX0035 is being studied as an investigational drug in
several other regions, as well as for the potential treatment of
ALS and other neurodegenerative diseases. The formulation of
RELYVRIO, ALBRIOZA and AMX0035 are identical.
RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety
Information for United States
WARNINGS AND PRECAUTIONS
Risk in Patients with Enterohepatic Circulation Disorders,
Pancreatic Disorders, or Intestinal Disorders
RELYVRIO contains taurursodiol, which is a bile acid. In
patients with disorders that interfere with bile acid circulation,
there may be an increased risk for worsening diarrhea, and patients
should be monitored appropriately for this adverse reaction.
Pancreatic insufficiency, intestinal malabsorption, or intestinal
diseases that may alter the concentration of bile acids may also
lead to decreased absorption of either of the components of
RELYVRIO. Because different enterohepatic circulation, pancreatic,
and intestinal disorders have varying degrees of severity, consider
consulting with a specialist. Patients with disorders of
enterohepatic circulation (e.g., biliary infection, active
cholecystitis), severe pancreatic disorders (e.g., pancreatitis),
and intestinal disorders that may alter concentrations of bile
acids (e.g., ileal resection, regional ileitis) were excluded from
the study; therefore, there is no clinical experience in these
conditions.
Use in Patients Sensitive to High Sodium Intake
RELYVRIO has a high salt content. Each initial daily dosage of 1
packet contains 464 mg of sodium; each maintenance dosage of 2
packets daily contains 928 mg of sodium. In patients sensitive to
salt intake (e.g., those with heart failure, hypertension, or renal
impairment), consider the amount of daily sodium intake in each
dose of RELYVRIO and monitor appropriately.
ADVERSE REACTIONS
The most common adverse reactions (at least 15% and at least 5%
greater than placebo) with RELYVRIO were diarrhea, abdominal pain,
nausea, and upper respiratory tract infection.
Gastrointestinal-related adverse reactions occurred throughout the
study but were more frequent during the first 3 weeks of
treatment.
Please click here for RELYVRIO Full U.S.
Prescribing Information.
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 the Company’s 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, 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’ 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231128538912/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
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