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Re: DewDiligence post# 76623

Wednesday, 05/15/2013 5:04:13 PM

Wednesday, May 15, 2013 5:04:13 PM

Post# of 257251
FDA approves JNJ’s Simponi for ulcerative colitis:

http://finance.yahoo.com/news/simponi-golimumab-receives-fda-approval-201500872.html

Simponi is a “second-generation” anti-TNF-alpha drug whose approved indications are a subset of those for Remicade, Enbrel, and Humira. It was approved by the FDA for its initial indications in 2009 (#msg-37306991).

The commercial rights for Simponi are divided geographically in exactly the way as the commercial rights for Remicade: JNJ has the rights in most of the world (all countries except EU, Russia, Turkey, and Japan); MRK has the rights in the EU, Russia, and Turkey; and Mitsubishi has the rights in Japan.

In 1Q13, Simponi sold at a $1B annualized rate in JNJ’s territories and a $400M annualized rate in MRK’s territories. In other words, Simponi is a decent-selling drug, but its sales are tiny compared to Remicade, Enbrel, and Humira.

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