The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) recently did not recommend
the approval of
Isis Pharmaceuticals Inc.
) and partner Genzyme's, a
) company, candidate Kynamro (mipomersen).
The companies are seeking US Food and Drug Adminstration (FDA)
approval for the use of Kynamro for the treatment of patients
with homozygous familial hypercholesterolemia (HoFH). Sanofi is
working on getting the negative CHMP decision re-examined and
expects to have a final opinion in the second quarter of
We note that the regulatory path of Kynamro has been quite the
opposite in the US. In October 2012, the US Food and Drug
Administration's (FDA) Endocrinologic and Metabolic Drugs
Advisory Committee voted in favor of approving Kynamro. The panel
voted 9 to 6 that sufficient data is available on Kynamro's
efficacy and safety profile for gaining final approval.
A response from the FDA is expected by January 29, 2013.
Approval would trigger a $25 million milestone payment from
Kynamro is the lead pipeline candidate at Isis Pharma. Isis
Pharma and Genzyme are also seeking approval for the candidate in
severe heterozygous familial hypercholesterolemia (HeFH)
Although we believe Kynamro has blockbuster potential, we
remain worried that concerns regarding the safety profile of the
drug could limit its commercial potential once launched.
Additional competition in the form of
Aegerion Pharmaceuticals, Inc.'s
) lomitapide, which is under FDA review, could also hamper the
sales of Kynamro.
We believe that antisense technology (the main area of focus
at Isis Pharma) represents an exciting and potentially
revolutionary platform for developing therapeutic candidates to
treat a wide margin of diseases. The company has partnership
agreements with leading pharmaceuticals companies like
), among others.
Large-cap pharma stocks currently holding a Zacks #2 Rank
include companies like
Johnson & Johnson
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