Tuesday, September 01, 2015

Valeant in-licenses global rights to brodalumab outside of Japan and other Asian geographies as it further grows into the dermatology space

Valeant in-licenses global rights to brodalumab

From: UpdatesPlus-Psoriasis our regular psoriasis monitoring and analysis service
  • Just a few weeks ago we reported that AstraZeneca seemed likely to continue brodalumab development and that a new partner was being sought to replace Amgen
  • Amgen had earlier decided to discontinue development due to concerns over labelling relating to suicidality (See Amgen pulls out of brodalumab development amongst fears of suicidality - bad luck, bad target or victim of brodalumab's efficacy)
  • Valeant has now announced that it will in-license global rights to brodalumab from AstraZenecca.  
  • Valeant will make an upfront payment of $100M to AstraZeneca, with another $170M in prelaunch milestones and up to $175M following launch
  • Valeant will license exclusive global development and commercialization rights to brodalumab with the exception of Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen
  • After approval, AstraZeneca and Valeant will share profits although the profit split has not to our knowledge been disclosed
  • EU and US filing is expected Q4 2015
  • Valeant will assume all development costs associated with the regulatory approval for brodalumab

Comments:  Valeant had extensive commercial experience across the dermatology spectrum including actinic keratosis, acne and atopic dermatitis. A Steroid/Retinoid combination is expected to be filed for psoriasis in 2016.  Acquiring brodalumab could significantly expand Valeant's position in dermatology.  Under the terms of the current deal it seems that AstraZeneca will not be commercializing brodalumab if approved and instead Valeant will be responsible for this.  With Valeant's existing activity in dermatology and a limited level of AstraZeneca sales activity, this agreement seems logical.  On the other hand the deal will allow AstraZeneca to focus on immuno-oncology.  One barrier Valeant could face is its limited experience in biologics and in this respect it is of interest that AstraZeneca recently announced plans to invest $285M in a new biologics manufacturing facility in Sweden. The new plant will be focused on filling and packaging of protein therapeutics. Clinical trial material will be generated by 2018 with commercial capacity coming on line by 2019.  Biologics capacity at an existing site in Maryland is also reported to be expanded.  It is not known if these sites are to be responsible for brodalumab manufacture/filling - if this is however the case, brodalumab capacity may suffer a lag during the initial role out period (ie 2017/18)

Read more in our next issue of UpdatesPlus-Psoriasis our regular monitoring and analysis service. Reports are accompanied by ad hoc e-mail alerts providing near real time analysis of key breaking events. This alert along with all other recent events will be analyzed in our next issue of UpdatesPlus. Please contact jon.goldhill@leaddiscovery.co.uk

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