AbbVie Returns Eye Drug Candidate To Molecular Partners

AbbVie Returns Eye Drug Candidate To Molecular Partners

AbbVie Inc ABBV has terminated its license and collaboration agreement with Molecular Partners AG MOLN for abicipar pegol for neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). 

  • As such, Molecular Partners will regain the development and commercial rights of abicipar on a worldwide basis. Molecular Partners will form a special committee to evaluate the program and determine appropriate next steps for the abicipar. 
  • In addition, Molecular Partners and AbbVie will continue their ongoing discovery alliance, in which AbbVie will continue to evaluate additional DARPin candidates for ophthalmic indications. 
  • Abicipar is a long-acting anti-VEGF DARPin molecule invented by Molecular Partners and was initially licensed to Allergan in 2011. 
  • The program has been through two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50% fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.
  • With the acquisition of Allergan by AbbVie, the rights to abicipar were transferred to AbbVie. 
  • In June 2020, AbbVie received an FDA Complete Response Letter for abicipar pegol application, indicating that the rate of intraocular inflammation after Abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (nAMD).
  • In July 2020, Molecular Partners withdrew application filings with the European Medicines Agency and the Japanese Regulatory Agency for abicipar pegol.
  • Price Action: MOLN shares and ABBV stock closed at $19.50 and $114.45, respectively, on Friday.

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