Aegerion Pharmaceuticals Inc. obtained Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS)'s approval for Juxtapid.
Juxtapid has been approved in Mexico for the treatment of patients suffering from homozygous familial hypercholesterolemia (HoFH) as an adjunct to a low-fat diet and other lipid-lowering therapies. Juxtapid also gained orphan drug designation by COFEPRIS.
We note that Juxtapid, indicated for the treatment of patients suffering from HoFH, was launched in the U.S. in late Jan 2013. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion on the drug in May 2013 and Aegerion gained EU approval in Jul 2013 under the brand name Lojuxta.
Aegerion plans to initiate a therapeutic study on Juxtapid in pediatric patients in 2014. Discussions relating to the trial protocol design are underway with both the U.S. Food and Drug Administration (FDA) and EMA.
We however remind investors that Aegerion’s share price fell 13.22% on Jan 9, 2014, on the disclosure that the Department of Justice (DoJ) has issued a subpoena asking the company to provide documents related to the marketing and sale of Juxtapid. Aegerion’s share price has ever since trended down till Jan 16, 2014.
Juxtapid targets the highly competitive and crowded cardiovascular disease market. We note that Isis Pharmaceuticals Inc.’s Kynamro is also available in the HoFH market since first quarter of 2013 in the U.S. Aegerion currently carries a Zacks Rank #4 (Sell).
Some better-ranked players in the pharma industry include Medivation, Inc. and Lannett Co. Inc. (LCI - Free Report) . Both stocks carry a Zacks Rank #1 (Strong Buy).