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CHMP Positive on Aegerion's Lojuxta

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Aegerion Pharmaceuticals, Inc. recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lojuxta (lomitapide).

The company is looking to get Lojuxta approved in the EU as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adults with homozygous familial hypercholesterolemia (HoFH).

The Lojuxta marketing application was submitted for approval in the EU in the first quarter of 2012. A final decision on Lojuxta should be out in the third quarter of 2013. With the CHMP adopting a positive opinion, we expect Lojuxta to gain EU approval.

We note that Lojuxta is already available in the US under the trade name Juxtapid. Net product sales for the first quarter 2013 were $1.2 million.

Our Take

We are encouraged with the progress of Aegerion’s Juxtapid in the HoFH market. We expect investor focus to remain on the sales ramp up of Juxtapid. Aegerion expects 250 to 300 patients to be on Juxtapid therapy worldwide in 2013. We note that Kynamro, approved in the US in Jan 2013, has also entered the HoFH market.

Currently, companies like Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) are also looking to enter the hypercholesterolemia market.

In Feb 2013, Alnylam Pharma joined hands with The Medicines Company (MDCO - Free Report) forming an exclusive global alliance to develop and commercialize Alnylam’s ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia.

Aegerion carries a Zacks Rank #3 (Hold). Currently, Alnylam looks well positioned with a Zacks Rank #2 (Buy).

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