Aegerion Pharmaceuticals Inc.
) recently announced its 2013 guidance as the company prepares
for the launch of Juxtapid, which gained US Food and Drug
Administration (FDA) approval in December.
Juxtapid has been approved for the treatment of patients
suffering from homozygous familial hypercholesterolemia (HoFH) as
an adjunct to a low-fat diet and other lipid-lowering
Aegerion, at the end of 2012, started enrollment of Japanese
subjects into a phase I, bridging study of the pharmacokinetic
and pharmacodynamic properties of Juxtapid. Once study results
are out, the company plans to conduct a small therapeutic study
of Juxtapid in Japanese HoFH patients so that it can seek
approval in Japan.
As part of its post-marketing requirements, the company is
required to conduct a juvenile toxicology study in rodents. The
study will provide information on the impact of Juxtapid on
growth and development. This study needs to be conducted before
the company can initiates a study in pediatric patients,
potentially in 2014.
Cash and cash equivalents at the end of 2012 was roughly $78
million to $83 million.
For 2013, Aegerion expects to generate revenue between $15
million to $25 million assuming 250 to 300 patients are on
Juxtapid therapy by the end of the year.
Once Juxtapid is approved in the EU, the company expects to
achieve an annualized worldwide net revenues run rate of $100
million eighteen months after EU approval. The company also
expects to achieve cash flow breakeven from operations eighteen
motnhs after EU approval.
We are encouraged with the US approval of Juxtapid. We note
Isis Pharmaceuticals Inc.
) is also looking to enter the market with its HoFH candidate,
Kynamro, which is currently under review in the US.
We currently have a Neutral recommendation on Aegerion. The
stock carries a Zacks #3 Rank (Hold). Other stocks in the pharma
sector that carry a Zacks #1 Rank (Strong Buy) are
AEGERION PHARMA (AEGR): Free Stock Analysis
ISIS PHARMACEUT (ISIS): Free Stock Analysis
REPLIGEN (RGEN): Free Stock Analysis Report
TARGACEPT INC (TRGT): Free Stock Analysis
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