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According to GBI Research, 51% of the overall gastrointestinal therapeutic pipeline is in Phase II to Phase III development, of which 19 molecules are indicated for the treatment of Irritable Bowel Syndrome, 48 for ulcerative colitis, and 41 for Chron’s Disease. These pipeline drugs, coupled with the increasing prevalence of GI diseases could help stabilize what the research says could be a declining market.
The business intelligence firm is calling for a decline of the GI therapeutics market, from $6.8B in 2012 to a $6.6B in 2019. This is based on the patent expiry of both Humira and Remicade, and entries of generics and biosimilars impacting sales.
One drug from Takeda, vedolizumab will enter two new Phase III trials in Japan. In addition, Takeda has submitted a Marketing Authorization Application (MAA) to the EMA in March 2013, as well as a Biologics License Application (BLA) to the FDA in June 2013, for the treatment of moderately to severely active ulcerative colitis or Crohn’s disease. Inflectra or infliximab, the biosimilar of Remicade, is the first monoclonal antibody to be approved through the EMAs biosimilars regulatory pathway and will be marketed by Hospira and available in the EU in February 2015. The drug is indicated for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis psoriatic arthritis and psoriasis.The full release is available here.