The US Food and Drug Administration (FDA) recently approved
Kynamro (mipomersen sodium) injection developed by Genzyme, a
). Kynamro is approved for cholesterol management in patients
suffering from homozygous familial hypercholesterolemia
The FDA's decision did not come as a surprise. In Oct 2012,
the US regulatory body's Endocrinologic and Metabolic Drugs
Advisory Committee had voted in favor of approving Kynamro. The
approval of the drug triggers a $25 million milestone payment
We note that Kynamro carries a Boxed Warning citing the risk
of hepatic toxicity. Kynamro is available only through a Risk
Evaluation and Mitigation Strategy (REMS) because of the risk of
We believe this safety concern might to an extent undermine
the commercial potential of the drug.
Aegerion Pharmaceuticals Inc.
) Juxtapid (lomitapide) for HoFH patients, which was recently
launched, would also eat into Kynamro sales.
Meanwhile, Sanofi is working on re-examining the negative
decision related to Kynamro from the advisory board of the
European Medicines Agency (EMA). In Dec 2012, the Committee for
Medicinal Products for Human Use (CHMP) had recommended against
the approval of Kynamro.
We are encouraged with Kynamro's approval in the US which
validates the antisense technology. Isis Pharma has several other
candidates in the pipeline based on this technology.
Isis Pharma currently carries a Zacks Rank #3 (Hold).
) looks more attractive in the pharma sector with a Zacks Rank #1
(Strong Buy). Meanwhile, Sanofi carries a Zacks Rank #2
AEGERION PHARMA (AEGR): Free Stock Analysis
ISIS PHARMACEUT (ISIS): Free Stock Analysis
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