The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently re-examined and confirmed its decision to not recommend the approval of Isis Pharmaceuticals Inc. 's ( ISIS ) candidate Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). Isis Pharma is collaborating with Genzyme, a Sanofi ( SNY ) company, for the candidate.
Though not unexpected, we are disappointed with the rejection of Kynamro's appeal by the CHMP. We note that Isis Pharma's lead product, Kynamro received US Food and Drug Administration (FDA) approval in Jan 2013 for the treatment of HoFH. Sanofi is marketing the product in the US. Isis Pharma will share profits from Kynamro. The company will initially get 30% of the share, which will linearly increase to 50% as revenue touches the $2 billion mark on a yearly basis. Sanofi is also looking to get the drug approved in the rest of the world. Although we believe Kynamro has significant commercial potential, we remain worried regarding concerns about the safety profile of the drug.
We note that in the first quarter of 2013, Isis Pharma is expected to record significant milestone revenues. The company received a milestone payment of $25 million from Sanofi in Jan 2013 on US approval of Kynamro. In Feb 2013, Isis Pharma received a $7.5 million milestone payment from GlaxoSmithKline ( GSK ). The payment primarily relates to the initiation of a phase II/III clinical study of ISIS-TTRRx. The study will span 15 months enrolling 200 patients. Isis is developing ISIS-TTRRx in collaboration with Glaxo for the potential treatment of transthyretin (TTR) amyloidosis.
Isis Pharma currently carries a Zacks Rank #3 (Hold). Cytokinetics, Inc. ( CYTK ) looks more attractive in the pharma sector with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
