Friday, September 11, 2015

AstraZeneca further ups its biologics manufacturing capacity - further evidence of future brodalumab production?

In our recent alert announcing Valeant's decision to in-license psoriasis candidate, brodalumab from AstraZeneca we commented that the deal may suffer from a lack of manufacturing capacity for biologics.  AstraZeneca appears to be making a concerted effort to expand manufacturing capacity potentially addressing this

  • AstraZeneca has recently invested $285M in its Swedish biologics facility.  Capacity at an existing Maryland site is also to be expanded (see our original alert below)
  • Now AstraZeneca has announced  the purchase of a biologics bulk manufacturing facility from Amgen in Colorado
  • AstraZeneca reportedly plans to start staffing the facility immediately to support refurbishment and infrastructure improvements
  • Once complete, the site is expected to be operational and licensed for commercial production by late 2017
  • The facility will eventually double AstraZeneca's biologics manufacturing capacity in the US.
Comments:  Across the AstraZeneca/Medimmune pipeline at least 6 mAbs may be in a position to launch in the near term (Durvalumab, Moxetumomab and Tremelimumab for oncology and brodalumab, Benralizumab and Tralokinumab for immunology).  New capacity will be required to meet this over demand.  Although it is unclear whether AstraZeneca will be responsible for brodalumab manufacture under its deal with Valeant,  today's new makes it increasingly likely that it will be able to do so if necessary.  Furthermore until Amgen's recent decision to drop brodalumab it may have even been the intent to manufacture commercial supply at the Colorado site suggesting that processes are up and ready to rapidly meet demand

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