CHMP Positive on Aegerion's Lojuxta - Analyst Blog

By
A A A

Aegerion Pharmaceuticals, Inc. ( AEGR ) 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 ) and Alnylam Pharmaceuticals, Inc. ( ALNY ) are also looking to enter the hypercholesterolemia market .

In Feb 2013, Alnylam Pharma joined hands with The Medicines Company ( MDCO ) 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).



AEGERION PHARMA (AEGR): Free Stock Analysis Report

ALNYLAM PHARMA (ALNY): Free Stock Analysis Report

MEDICINES CO (MDCO): Free Stock Analysis Report

REGENERON PHARM (REGN): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: AEGR , ALNY , CHMP , LDL , MDCO

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Author Roger Martin LIVE
Author Roger Martin LIVE            

Stocks

Referenced

Most Active by Volume

118,446,482
  • $5.355 ▼ 19.35%
84,232,734
  • $17.085 ▲ 1.88%
66,632,718
  • $41.845 ▼ 1.75%
27,020,147
  • $4.495 ▲ 15.85%
26,182,908
  • $101.88 ▲ 0.30%
21,977,652
  • $100.09 ▲ 0.56%
21,668,362
  • $46.775 ▲ 0.55%
21,011,586
  • $5.75 ▼ 24.54%
As of 9/18/2014, 03:00 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com