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Novelion Therapeutics’ Subsidiary Launches JUXTAPID® (lomitapide) in Japan
Wednesday, December 28, 2016
Vancouver, BC, December 28, 2016--(T-Net)--Novelion Therapeutics (NASDAQ: NVLN) (TSX: NVLN), announced that subsidiary Aegerion Pharmaceuticals completed the first commercial shipment of JUXTAPID® (lomitapide) to a patient in Japan.
In September 2016, JUXTAPID was approved by Japan's Ministry of Health, Labor & Welfare (MHLW) for patients with homozygous familial hypercholesterolemia (HoFH).
Mary Szela, chief executive officer of Novelion said, “Japan is an important market and we are pleased to be able to provide this needed therapy to HoFH patients there shortly following the recent approval. Japan is unique in that there is a well-defined population of over 160 HoFH patients at last count registered with the Intractable Diseases Information Center. We are working closely with Japanese healthcare providers to identify those patients appropriate for JUXTAPID therapy, and following the recent approval of pricing and reimbursement in line with our expectations, we are working to bring HoFH patients in need onto therapy.”
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C (“bad” cholesterol) from the body. A loss of LDL receptor function results in extreme evaluation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
The MHLW based its approval of JUXTAPID on Aegerion's Phase III study in Japanese patients, which evaluated the safety and efficacy of the medicine to reduce LDL-C levels in nine patients with HoFH. The findings were consistent with the known safety and efficacy profile of JUXTAPID.
JUXTAPID is approved in the United States as an adjunct to a low-fat diet and other lipid lowering treatments, including apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with HoFH. In the U.S., JUXTAPID carries a boxed warning for the risk of hepatotoxicity. The boxed warning also states that JUXTAPID should only be prescribed to patients with a clinical or laboratory diagnosis consistent with HoFH, and that the safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. Because of the risk of hepatotoxicity and the importance of JUXTAPID only being prescribed to patients with a clinical or laboratory diagnosis consistent with HoFH, JUXTAPID is only available through the JUXTAPID REMS Program. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.
About Novelion Therapeutics
Novelion Therapeutics is a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases. The company seeks to advance its portfolio of rare disease therapies by investing in science and clinical development. 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 treatment of inherited retinal disease caused by underlying mutations in RPE65 or LRAT genes.
Forward Looking Statements:
This press release contains forward-looking statements, including statements regarding the potential for launch and commercialization of JUXTAPID in Japan. 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. In particular, the risks and uncertainties include, among other factors; the risk that JUXTAPID may not gain market acceptance for HoFH in Japan; the risk that HoFH patients may not be diagnosed and identified in the manner and at the levels we anticipate; and the other risks inherent in the commercialization process for orphan drug products in Japan. For additional disclosure regarding these and other risks we face, see the disclosure contained in the "Risk Factors" section of Aegerion's Quarterly Report on Form 10-Q filed on November 4, 2016, QLT's Annual Report on Form 10-K filed on February 25, 2016 (and amended on April 29, 2016) and Quarterly Report on Form 10-Q filed on November 1, 2016 and each company's other public filings with the SEC, available on the SEC's website at http://www.sec.gov. 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, except as required by law.
Investors and others should note that we communicate with our investors and the public using 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 this release or any filing under the Securities Act of 1933, as amended.
CONTACT:
Amanda Murphy, Associate Director, Investor & Public Relations
Novelion Therapeutics
857-242-5024
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