Aegerion Pharmaceuticals, Inc. recently obtained regulatory approval in the EU for Lojuxta. Lojuxta gained approval for use as an adjunct to a low-fat diet and other lipid-lowering medicines with or without low density lipoprotein (LDL) apheresis in adults with homozygous familial hypercholesterolemia (HoFH).
Approval was in line with expectations as, in May 2013, Aegerion had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lojuxta.
We note that Lojuxta is already available in the U.S. under the trade name Juxtapid. Juxtapid, the company’s only marketed product, was launched in the U.S. in Jan 2013.
We are encouraged by Juxtapid’s performance. Net product sales for the second quarter were $6.5 million. Currently, there are 215 patients under Juxtapid therapy as compared to 75 patients in the last quarter. As per estimates provided by Aegerion, there are at least 3,000 potential patients for Juxtapid in the U.S. We expect investor focus to remain on the sales ramp up of the drug.
Aegerion is looking to increase its global foothold. It has completed or is in the process of filing regulatory applications in Taiwan, Mexico, Argentina, Canada, Brazil and Israel.
Furthermore, the company has received orphan drug status for Lojuxta in Japan from The Pharmaceuticals and Medical Devices Agency (PMDA). Aegerion expects to file a New Drug Application (NDA) in the first half of 2015 in Japan.
Currently, companies like Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) are also looking to enter the hypercholesterolemia market.
Aegerion carries a Zacks Rank #2 (Buy). Biopharmaceutical companies like Actelion Ltd. look better positioned with a Zacks Rank #1 (Strong Buy).