Tuesday, September 02, 2014

Alert - UpdatesPlus: Novo Nordisk comes out of inflammation

Novo Nordisk is discontinuing all R&D activities within inflammatory disorders in order to focus on metabolic disorders [link]

For further information on this news and all other key breaking research and development across the inflammation arena ask about our UpdatesPlus service (click here for an example)
  • The company had active clinical development programs in IBD, Lupus and RA
    • In SLE, Novo was conducting Phase 1 studies of NN-8828 (IL-21)
    • NN-8828 was also in Phase 2 development for IBD, an indication that Novo has also been developing NN-8555 (NKG2).  Of note, development of NN-8555 was stopped due to futility.  Development was however subsequently restarted following a reanalysis suggesting that efficacy may in fact appear at later timepoints than initially expected
    • RA was the most advanced therapy areas for Novo, where NN-8226, an IL-20 was being developed.  As discussed in our most recent issue of UpdatesPlus-RA, this candidate was terminated in Phase 2b with ACR20 rates showing no improvement over placebo at 12wks.  Earlier stage candidates were NN-8210, a C5aR antibody.  This Phase 1 candidate was a follow on to NN-8209 which was discontinued last year due to high rates of immunogenicity
  • Novo has reportedly commented that with the termination of NN-8226, its earliest possible entrance into anti-inflammatory market will be the late 2020s
  • The decision will affect ~400 employees, with ~200 being relocated to other parts of the organization
Comments:  Despite today's news, we believe that Novo has an interesting clinical portfolio.  The company has turned out multiple candidates suggesting that behind this portfolio, R&D activities may have many more candidates.  NN-8828 seems to be the most advanced, and we anticipate that launch could be earlier than the late 2020s indicated if developed expeditiously. 

We believe that at least three contributory factory may have underlined Novo's decision to come out of inflammation. 

Firstly, the inflammatory pipeline seems to carry a little more risk than the overall inflammatory disease area.  For example, NN-8555 development was terminated and then re-started, questioning efficacy.  Likewise Novo's C5aR antibodies have been associated with immunogenicity, although this seems to have been resolved. 

Secondly, Novo has limited late stage development expertise in the inflammation arena meaning that speed of development, and establishing market presence may have been doubted internally. 

Thirdly, Novo has suffered manufacturing set backs in recent months - specifically it was forced to delay launch expectations for its long-acting FVIII product (for hemophilia) by about 3 years because it concluded late on in development that capacity was not sufficient.  This has resulted in the company being forced to drastically increase manufacturing capabilities.  This has likely not only forced budget to be diverted away from inflammatory diseases, but also led senior management to question investment required to further increase biologic capabilities had inflammation R&D been continued. 

Overall, we suggest that despite Novo's decision, other companies may want to evaluate the benefit of acquiring Novo's remaining portfolio.  We see opportunities greatest for those companies with pre-existant capabilities and portfolios in the area, and with a need to bolster mid-late term options


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