AbbVie has terminated its license and collaboration deal with Molecular Partners for abicipar pegol, and returned all rights to the Swiss company. Here’s more about it.
AbbVie recently returned the rights of the eye drug Abicipar pegol.
AbbVie has terminated its license and collaboration deal with Molecular Partners for Abicipar pegol and returned all rights to the Swiss company. The original deal was between Allergan and Molecular Partners. When AbbVie acquired Allergan, the rights to the drug were transferred to AbbVie.
On June 26, 2020, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) of Allergan’s Biologics License Application (BLA) for the drug for neovascular age-related macular degeneration (nAMD). The rejection was related to safety concerns, with the FDA stating that the “rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.06 mL results in an unfavorable benefit-risk ratio.”
At the time, Michael R. Robinson, vice president, Global Therapeutic Area Head, Ophthalmology, AbbVie, stated, “We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD. We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”
The BLA had been submitted with data from two identical Phase III trials, CEDAR and SEQUOIA. Both trials compared the drug to Genentech’s Lucentis (ranibizumab) in treatment-naïve patients with nAMD. The primary endpoint for both trials was the proportion of patients with the best corrected visual acuity (BCVA) change from baseline less than or equal to 15 letters in the study eye at Week 52. The data showed the Abicipar pegol was non-inferior with similar efficacy as Lucentis after six or eight injections compared to 13 Lucentis injections at 52 weeks. And although the overall adverse events were similar among all three treatment arms, the FDA apparently did not agree.
Molecular Partners indicates it plans to form a special committee to evaluate the program and decide on what the next pathway might be. Molecular Partners and AbbVie will continue a partnership, where AbbVie will continue to study other Designed Ankyrin Repeat Proteins (DARPin) candidates for ophthalmic diseases.
DARPin molecules come from naturally occurring binding proteins made up of repeat sequences with capping structures at each end of the protein. These molecules have three components that are important for researchers: high binding affinity, low molecular weight and customizable applications. Abicipar pegol is made up of DARPin molecules. It binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) A, which prevents neovascularization and vessel permeability in the eye.
The original partnership made Molecular Partners eligible for up to $1.5 billion in various milestones.
Abicipar pegol is a long-acting anti-VEGF DARPin molecule. It was invented by Molecular Partners and licensed to Allergan in 2011. Molecular Partners believes, at least for now, that improvements made to their manufacturing processes and the formulation can overcome the inflammatory issues the FDA had problems with.
The drug was being developed for nAMD as well as Diabetic Macular Edema (DME).
“There remains a significant unmet medical need for patients living with nAMD and DME, and we remain confident in abicipar’s potential to offer these patients a differentiated treatment option over existing therapies,” said Patrick Amstutz, Molecular Partners’ chief executive officer. “Our focus for this program will be determining the best path to value creation within the context of our expansive portfolio of antiviral and immuno-oncology therapies in development.”
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