Shares of Hospira Inc. (HSP) have been on the upswing ever since the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of its Inflectra (infliximab) for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. The European Commission will review the CHMP’s opinion and a final decision is expected in the next three months. Shares of this provider of injectable drugs and infusion technologies hit a 52-week high of $39.38 on Jul 1.
We note that Inflectra is the biosimilar version of Johnson & Johnson / Merck & Co. Inc.’s (JNJ/MRK) blockbuster drug Remicade. Hospira noted in its press release that Inflectra is the first monoclonal antibody therapy to receive a favorable opinion from the CHMP after review through the EMA biosimilars regulatory pathway. Hospira stated in its press release that Remicade sales crossed the $2 billion mark in 2012.
Positive results on Inflectra from a phase III study supported the positive opinion issued by the CHMP. Inflectra met its primary endpoint of therapeutic equivalence to Remicade in the study. Data also revealed that the safety and tolerability of Inflectra was comparable to Remicade. Hospira currently enjoys the rights to Inflectra in Europe, the US, Canada, Australia and New Zealand under the agreement it signed with South Korean company, Celltrion, in 2009.
Hospira, which currently markets two biosimilars in Europe, boasts of a strong biosimilars pipeline with 11 candidates in development. Biosimilars, which are generic versions of biologic drugs, are expected to be a significant growth driver in the generics industry in the coming years. The biosimilars market represents huge commercial opportunity with a significant amount of biologic sales slated to lose patent protection in the coming years.
Hospira carries a Zacks Rank #3 (Hold). AtriCure, Inc.(ATRC) appears to be more favorably placed in the medical sector with a Zacks Rank #2 (Buy).
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