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Insmed Incorporated Message Board

  • blank2thisone blank2thisone Aug 31, 2014 6:45 PM Flag

    Roche pays $8.3B for Intermune & UBS rates INSM take over candidate - NTM & CF will fly in EU in 2015 - 40 months till IPLEX is of the shelf

    Roche pays $8.3B for Intermune

    This, for the drug Esbriet (pirfenidone), which is expected to generate $1B in yearly revenue by 2019 for the treatment of idiopathic pulmonary fibrosis (IPF), an orphan disease. On February 28, 2011, the European Commission (EC) granted marketing authorization in all 28 EU member states. It is also available in Canada, Japan, South Korea, China, India, Argentina and Mexico, BUT NOT IN THE U.S., in spite of the drug receiving FDA Orphan Designation, Priority Review Designation, Fast Track Status and Breakthrough Designation. What happened? In one of two p3 trials completed in 2009, the primary endpoint was not met (p=0.501). For this failure, the company was set back by 5 years by the FDA. A third p3 trial was mandated and now they are resubmitting their NDA to the FDA in 3rd qtr 2014.

    Does all this sound familiar? Orphan drug. Estimated revenue= $1B/yr. Relaxed standards abroad. BS FDA designations mean nothing in the US if you fail primary endpoint. If we follow the pattern, look for approval in the EU and possibly Japan. We shall see (thanks b_leagured)

    This is so much fun!!

    Sentiment: Strong Buy

14.57-0.19(-1.29%)Sep 26 4:00 PMEDT