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
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
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.
Alnylam Pharmaceuticals, Inc.
) are also looking to enter the hypercholesterolemia market.
Aegerion carries a Zacks Rank #2 (Buy). Biopharmaceutical
) look better positioned with a Zacks Rank #1 (Strong Buy).
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