Aegerion's Juxtapid Gets Pricing Authorization In Japan
Zacks Investment Research | Nov 18, 2016 05:27AM ET
Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) announced that Japan's Ministry of Health, Labor & Welfare (MHLW) has approved the pricing authorization of its first product, Juxtapid. The product was approved in Japan in September for the treatment of homozygous familial hypercholesterolemia (HoFH). In Sep 2013, MLHW granted orphan drug status to Juxtapid.
Notably, HoFH is a rare genetic lipid disorder that impairs the function of the receptor responsible for removing LDL-C ("bad" cholesterol) from the body.
Juxtapid was launched in the U.S. in late Jan 2013, 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 (LDL-C), total cholesterol (TC), apolipoprotein B and non-high-density lipoprotein cholesterol (non-HDL-C) for the treatment of adult patients suffering from HoFH. In the U.S., the drug carries a boxed warning for the risk of hepatotoxicity.
Juxtapid gained EU approval under the trade name Lojuxta in Aug 2013.
Sales of Juxtapid declined 45.5% in the second quarter and 62.6% in the third quarter of 2016 from the year-ago levels due to a reduction in patients on therapy in the U.S., as a result of increased competition from PCSK9 inhibitors. The launch of Amgen, Inc.’s (NASDAQ:AMGN) Repatha and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) / Sanofi’s (NYSE:SNY) Praluent in the U.S. market dampened Juxtapid sales and will continue to do so in the forthcoming quarters.
In July, Aegerion announced plans to withdraw Juxtapid from the EU and certain other global markets by the end of 2016, unless it finds suitable partners as part of the company’s strategy to lower operating expenses, improve cash position amid stiff competition for Juxtapid, and increase cash generation from operations in 2017.
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