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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. (ISIS - Analyst Report) and partner Genzyme’s, a Sanofi (SNY - Analyst Report) 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 2013.
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 Sanofi.
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) indication.
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 (AEGR - Snapshot Report) 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 Biogen (BIIB - Analyst Report), Eli Lilly (LLY - Analyst Report) and GlaxoSmithKline (GSK - Analyst Report), among others.
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