The US Food and Drug Administration (FDA) recently approved Kynamro (mipomersen sodium) injection developed by Genzyme, a Sanofi company (SNY - Analyst Report) and Isis Pharmaceuticals Inc. . Kynamro is approved for cholesterol management in patients suffering from homozygous familial hypercholesterolemia (HoFH).
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 from Sanofi.
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 hepatic toxicity.
We believe this safety concern might to an extent undermine the commercial potential of the drug. Aegerion Pharmaceuticals Inc.'s (AEGR - Analyst Report) 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). Medivation Inc. looks more attractive in the pharma sector with a Zacks Rank #1 (Strong Buy). Meanwhile, Sanofi carries a Zacks Rank #2 (Buy).