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.