Aegerion Pharmaceuticals, Inc.
) shares gained 5.7% immediately after the commencement of a
phase III study in Japan to evaluate Juxtapid as an adjunct
treatment to reduce low-density lipoprotein cholesterol (LDL-C)
in homozygous familial hypercholesterolemia (HoFH) patients.
However, shares went down by 4.8% in the next trading session.
Overall shares were up 0.6% on the news. Aegerion is currently
enrolling patients in this study.
The open-label phase III study is designed to mirror the
completed phase III study conducted in the U.S. and other
countries. The enrolled patients will be given concomitant
lipid-lowering therapies. Following a six-week run-in period,
patients will receive Juxtapid starting at 5 mg/day and rising to
a maximum of 60 mg/day depending on tolerability for 26 weeks.
After 26 weeks, patients will enter a 30-week safety phase.
The percentage changes in LDL-C levels from baseline to week
26 constitute the primary endpoint of the study. Secondary
endpoints of the study include percentage change in lipid
parameters, long-term safety, and changes in hepatic fat from
baseline to week 56.
Juxtapid was granted orphan drug designation in Japan last
year. As indicated by the Japanese regulatory authorities, new
drug application (NDA) can be filed following completion of the
26-week efficacy period. Aegerion expects to file for approval in
Aegerion's sole marketed drug Juxtapid for the HoFH indication
was launched in Apr 2012 in the U.S. and demand has been rising
ever since. Moreover, Aegerion gained EU approval for the drug in
Jul 2013 under the brand name Lojuxta. Net Juxtapid revenues in
2013 were $48.5 million.
Juxtapid targets the highly competitive and crowded
cardiovascular disease market. We note that
Isis Pharmaceuticals Inc.
) Kynamro is also available in the U.S. HoFH market since the
first quarter of 2013.
Aegerion carries a Zacks Rank #3 (Hold). Investors looking for
better-ranked stocks in the biopharma sector may consider a
), which carries a Zacks Rank #2 (Buy)
AEGERION PHARMA (AEGR): Free Stock Analysis
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