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An Update On Epirus In Light Of Recent Developments

A bit over one month ago, I wrote an article recommending Epirus Biopharmaceuticals, Inc. (EPRS) as an attractive high risk/high reward investment. Two material developments have occurred since, which warrant review of the investment thesis. First, the FDA recently added clarity on the regulatory process for approval of biosimilars in the United States. Second, Epirus announced a secondary offering issuing new stock to fund its research and development.

Both these developments are net positives and provide clarity for Epirus moving forward. To summarize very briefly, an investment in Epirus is highly dependent on the company's ability to bring BOW015, a biosimilar of Remicade, to market in the United States and Europe. Remicade, marketed by Johnson & Johnson (JNJ), Merck Schering (MRK) and Mitsubishi Tanabe (OTCPK:MTZPY), generated approximately $8.4B in global sales in 2013.

Recent Biosimilar Developments

In early January, the FDA released documents concluding that Sandoz's EP2006 demonstrated "no clinicallyRead More …