Canadian Nod for Aegerion's Juxtapid

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Aegerion Pharmaceuticals, Inc.’s (AEGR) Juxtapid was approved in Canada as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without low-density lipoprotein (LDL) apheresis, for the reduction of LDL cholesterol (LDL-C) in adults suffering from homozygous familial hypercholesterolemia (HoFH). Aegerion gained over 5.5% on the news.

We note that Juxtapid was launched in the U.S. in late Jan 2013 for the HoFH indication. Moreover, Aegerion gained EU approval for the drug in Jul 2013 under the brand name Lojuxta. Juxtapid was also approved in Mexico last month for the same indication.

Juxtapid’s label carries a boxed warning regarding the risk of liver toxicity. Given the risk, Juxtapid is available through a limited program under the Risk Evaluation and Mitigation Strategy (:REMS). This program is called the Juxtapid REMS program.

We are encouraged by the approval of Juxtapid in Canada. Aegerion is slowly recovering from the blow it received last month. Aegerion’s share price fell over 12.1% on Jan 10, 2014, on the disclosure that the Department of Justice has issued a subpoena asking the company to provide documents related to the marketing and sale of Juxtapid.

Moreover, Juxtapid targets the highly competitive and crowded cardiovascular disease market. We note that Isis Pharmaceuticals Inc./Sanofi’s (ISIS/SNY) Kynamro is also available in the U.S. HoFH market since the first quarter of 2013. We expect investor focus to remain on the HoFH drug going forward.

Aegerion, a biopharma stock, currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the same sector include Actelion Ltd. (ALIOF).  Actelion holds a Zacks Rank #1 (Strong Buy).

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