Novelion Therapeutics Strengthens Leadership Team with Appointment of Murray Stewart, M.D., as Executive Vice President, Head...
October 12 2017 - 9:15AM
Novelion Therapeutics Inc. (NASDAQ:NVLN), a
biopharmaceutical company dedicated to developing new standards of
care for individuals living with rare metabolic diseases, today
announced the appointment of Murray Stewart, M.D. as Executive Vice
President, Head of R&D, effective November 27, 2017.
Chief Executive Officer Mary Szela said, “We are
very pleased to welcome Dr. Murray Stewart to Novelion, and believe
his deep metabolic drug development and broad industry experience
within both large pharma and biotech companies makes him uniquely
suited to lead our clinical development activities, provide
strategic regulatory guidance for our pipeline and commercial
product activities, and provide oversight of our global medical
affairs, publications and registry activities.”
Ms. Szela continued, “Dr. Stewart’s long history
in successfully developing cardiovascular and metabolic therapies,
global regulatory knowledge, and consumer experience will allow him
to make immediate contributions in advancing our clinical
development strategy for metreleptin. Leptin is a fundamentally
important hormone in the regulation of energy homeostasis, fat
metabolism, glucose metabolism, and body weight. Under the
leadership of Dr. Stewart, our goal is to harness the therapeutic
potential of metreleptin in certain diseases associated with
hypoleptinemia. In addition, his deep cardiovascular knowledge will
support our efforts to facilitate with physicians and other
stakeholders a better understanding of homozygous familial
hypercholesterolemia, and to leverage the clinical and
post-marketing data of lomitapide.”
Dr. Stewart will join Novelion from
GlaxoSmithKline (GSK) where he is currently chief medical
officer with global responsibility for patient well-being across
the vaccines, pharmaceutical and consumer business units. He joined
GSK in 2000 as associate director for clinical research &
development in the UK and has since held a variety of positions
within GSK, primarily in R&D. He was previously clinical head
of the biopharm unit and also therapy area head for the
cardiovascular and metabolic therapy areas. Prior to joining
the pharmaceutical industry, Dr. Stewart worked as a diabetes
consultant and senior lecturer and was consultant
physician/honorary senior lecturer and head of clinical services at
the Diabetes Centre, Newcastle upon Tyne in the United Kingdom
(UK). His research was in lipid metabolism in type 2
diabetes. Dr. Stewart completed his medical training at Southampton
Medical School in the UK and is a Fellow of the Royal College of
Physicians.
Dr. Stewart added, “With metreleptin, I believe
we have a significant opportunity to help patients with unmet need
given the breadth of its potential effects across a number of
indications associated with hypoleptinemic metabolic disorder. I
look forward to progressing these development plans for the benefit
of patients.”
About Novelion Therapeutics
Novelion Therapeutics is a biopharmaceutical
company dedicated to developing new standards of care for
individuals living with rare diseases. Novelion has a diversified
commercial portfolio through its indirect subsidiary, Aegerion
Pharmaceuticals, Inc., which includes MYALEPT® and JUXTAPID®, and
is also developing zuretinol acetate for the potential treatment of
inherited retinal disease caused by underlying mutations in RPE65
or LRAT genes. The company seeks to advance its portfolio of rare
disease therapies by investing in science and clinical
development.
Forward Looking Statements
Certain statements in this press release
constitute "forward-looking statements" of Novelion within the
meaning of applicable laws and regulations and constitute
"forward-looking information" within the meaning of applicable
Canadian securities laws, including statements regarding
expectations about the potential expansion of MYALEPT development
and our development programs in general. Forward-looking
statements are based on estimates and assumptions made by Novelion
in light of current conditions and expected future developments, as
well as other factors that Novelion believes are appropriate in the
circumstances, including, but not limited to, receipt of regulatory
approvals, product competition, market acceptance, sales, pricing,
reimbursement and side effects of our products. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements. Many such risks, uncertainties
and other factors are taken into account as part of our assumptions
underlying these forward-looking statements and include, among
others, the following: the risk that regulatory authorities in
regions or countries where MYALEPT or JUXTAPID is not yet approved
may refuse to approve such products or that regulatory authorities
may refuse to approve additional indications for such products,
such approvals are not made on a timely basis or such approvals
impose significant restrictions or require additional development;
the risk that the initiation of future clinical trials may be
delayed or that larger or a greater number of clinical trials
necessary to obtain approvals of indications for our products may
be required; the risk that we will not be successful in our
lifecycle management or business development efforts; and the other
risks inherent in the drug development, regulatory approval, and
commercialization process. For additional disclosure regarding
these and other risks we face, see the disclosure contained in the
"Risk Factors" section of Novelion's Annual Report on Form 10-K
filed on March 30, 2017, available on the SEC's website at
www.sec.gov. Except as required by law, we undertake no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Investors and others should note that we
communicate with our investors and the public using our company
website www.novelion.com, including, but not limited to, company
disclosures, investor presentations and FAQs, SEC filings, press
releases, public conference calls transcripts and webcast
transcripts. The information that we post on these websites could
be deemed to be material information. As a result, we encourage
investors, the media and others interested to review the
information that we post there on a regular basis. The contents of
our website shall not be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended.
U.S. INDICATIONS AND IMPORTANT SAFETY
INFORMATION
MYALEPT® (metreleptin) for injection is a leptin
analog indicated as an adjunct to diet as replacement therapy to
treat the complications of leptin deficiency in patients with
congenital or acquired generalized lipodystrophy. LIMITATIONS OF
USE: The safety and effectiveness of MYALEPT for the treatment of
complications of partial lipodystrophy or for the treatment of
liver disease, including nonalcoholic steatohepatitis (NASH), have
not been established.
Anti-metreleptin antibodies with neutralizing
activity have been identified in patients treated with MYALEPT.
T-cell lymphoma has been reported in patients with acquired
generalized lipodystrophy, both treated and not treated with
MYALEPT. For more detailed information, please see additional
Important Safety Information and the Prescribing Information for
MYALEPT.
JUXTAPID® (lomitapide) capsules is a microsomal
triglyceride transfer protein inhibitor indicated as an adjunct to
a low-fat diet and other lipid-lowering treatments, including
low-density lipoprotein (LDL) apheresis where available, to reduce
LDL cholesterol, total cholesterol, apolipoprotein B, and
non-high-density lipoprotein cholesterol in patients with
homozygous familial hypercholesterolemia (HoFH). LIMITATIONS OF
USE: The safety and effectiveness of JUXTAPID have not been
established in patients with hypercholesterolemia who do not have
HoFH, including those with heterozygous familial
hypercholesterolemia (HeFH). The effect of JUXTAPID on
cardiovascular morbidity and mortality has not been determined.
JUXTAPID can cause elevations in transaminases,
as well as increases in hepatic fat, with or without concomitant
increases in transaminases. Because of the risk of hepatotoxicity,
JUXTAPID is available only through a restricted distribution
program called the JUXTAPID REMS PROGRAM. For more detailed
information, please see additional Important Safety Information and
the Prescribing Information for JUXTAPID.
CONTACT:
Amanda Murphy, Director, Investor Relations & Corporate
CommunicationsNovelion
Therapeutics857-242-5024amanda.murphy@novelion.com
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