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Biotech Stocks: Amgen Up Due To Positive Phase III Data

Amgen Inc (AMGN) was up almost 3% on encouraging top-line data from a phase III study on its biosimilar candidate, ABP 501. The randomized, double-blind, active-controlled study compared the safety and efficacy of ABP 501 to AbbVie Inc’s (ABBV) Humira in adults suffering from moderate-to-severe plaque psoriasis.

The study met its primary endpoint of Psoriasis Area and Severity Index (PASI) percent improvement from baseline at the 16th week of treatment. At week 16, the PASI percent improvement from baseline was observed to be within the pre-specified equivalence margin for ABP 501 as compared to Humira. ABP 501’s immunogenicity and safety profile was found to be comparable with Humira.

This is the first of two phase III studies on ABP 501. Amgen plans to submit regulatory applications based on data from these two studies.

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ABP 501 is being developed as a biosimilar to Humira. Humira is approved in several countries for the treatment of several inflammatory diseases including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis.

We note that Amgen has six biosimilar candidates in development, three of which are already being evaluated in pivotal studies. The company expects to launch these drugs beginning 2017.

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Amgen (AMGN) reported impressive top-line results on its biosimilar version of AbbVie’s blockbuster drug, Humira. Amgen’s biosimilar met the primary endpoint in a late-stage study conducted in patients with moderate-to-severe plaque psoriasis. We are pleased with the positive top-line phase III data on ABP 501. If approved, it may capture some of Humira’s market share. During the first half of 2014, Humira revenues were $5.9 billion, up 22.2% from the year-ago period.

The company is currently conducting another phase III study with the biosimilar. Amgen’s target is to start launching biosimilars (it currently has six in development) from 2017.

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