Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration

DUBLIN, IRELAND – SEPT 9, 2019 – Allergan plc (NYSE: AGN), a leading global pharmaceutical
company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN),
a clinical-stage biotechnology company developing a new class of drugs known as DARPin®
platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted a
Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a
Marketing Authorisation Application (MAA) for Abicipar pegol, a novel, investigational
DARPin® therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD).
The FDA is expected to take action on the BLA mid-2020. A decision from the European
Commission is expected in the second half of 2020.

The BLA and MAA filings are based on data from two Phase 3 trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.

Press release