Wednesday, September 09, 2015

Biogen licenses S1P modulator MT-1303 from Mitsubishi for the development in multiple sclerosis, IBD (crohn's disease and ulcerative colitis) and more

Biogen licenses S1P modulator MT-1303 from Mitsubishi [Link]

  • Biogen will receive worldwide development and commercialization rights to MT-1303, excluding Asia for $60M plus further milestone payments of up to $484M
  • MT-1303 is an oral S1P modulator which halts T cell exit from lymph nodes and hence their movement to disease sites
  • The lead indication for MT-1303 is multiple sclerosis for which a Phase 2 study has been successfully completed and Biogen is now set to accelerate development for this indication
  • Biogen will also develop the molecule for inflammatory bowel disease, initiating an ulcerative colitis study with the  existing Crohn’s disease program to advance to Phase 3
  • Mitsubishi has the right to participate in Biogen’s global clinical trials and has co-promote non-multiple sclerosis indications in the US
Note that post is from our UpdatesPlus service offering ad hoc analaysis and in depth monthly reports of breaking R&D spanning IBD, Lupus, Psoriasis and much more.  For further information and sample reports please contact

Comments: Biogen is a field leader in the development of multiple sclerosis treatments (contact us for a full landscape of the multiple sclerosis area) and it is not surprising that it has secured this acquisition.  Gilenya has already established proof of concept for the development of S1P modulators for this indication.  AEs associated with Gilenya have prompted the development of more selective molecules from this class.  MT-1303 is quite far advanced but still behind Ozanimod (RPC1063).  Receptos developed this molecule prior to the company's acquisition by Celgene which completed  two weeks ago.  Celgene expects approval for Ozanimod in 2018 meaning that Biogen would have to significantly accelerate its own Phase 3 program to be competitive

In addition to multiple sclerosis, S1P modulators are in development for lupus, IBD and psoriasis.  Data are especially encouraging for IBD.  Again, Ozanimod leads the field with TOUCHSTONE, which was reported at ECCO and DDW this year, demonstrating improved rates of clinical remission in ulcerative colitis patients. Mucosal healing was also improved.  A Phase 3 Ozanimod study in ulcerative colitis opened May 2015.  Again, Biogen will have to accelerate development to compete with Ozanimod

Biogen's licensing activity is also of interest in terms of its activity in the broader autoimmune space.  While the company is an player established in multiple sclerosis, it has limited activity in other autoimmune diseases with the exception of lupus.  This suggests Biogen may accelerate MT-1303 development for lupus as well as leverage its acquisition of MT-1303 to gain a broader footprint in immunology.  Of note, Biogen is developing a biosimilar portfolio with Samung and developing a combination of established biologics alongside next generation small molecules could not only be attractive commercially but also allow rapid franchise expansion

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