|Page (1) of 1 - 10/12/17||email article||print page|
VANCOUVER, British Columbia, Oct. 12, 2017 (GLOBE NEWSWIRE) -- 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. Stewarts 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.
Amanda Murphy, Director, Investor Relations & Corporate Communications