Allergan Withdraws EU, Japan Filing For Macular Degeneration Drug

AbbVie’s (ABBV) Allergan has told Molecular Partners that it will withdraw application filings with both the European Medicines Agency (EMA) and the Japanese Regulatory Agency (PMDA) for Abicipar pegol, a novel DARPin therapeutic for patients with neovascular (wet) age-related macular degeneration (nAMD).

Age-related macular degeneration (AMD) occurs when a part of the retina called the macula is damaged, resulting in disturbance to the central visual field. Wet nAMD is less common but much more serious than dry AMD. Wet AMD is when new, abnormal blood vessels grow under the retina, causing scarring of the macula.

In June 26, the U.S. Food and Drug Administration (FDA) rejected the Biologics License Application (BLA) for Abicipar pegol.

According to the FDA’s Complete Response Letter, the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL resulted in an unfavorable benefit-risk ratio in the treatment of nAMD.

“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,” said Michael R. Robinson of Ophthalmology at AbbVie. “We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”

The global need for eye health services is projected to increase dramatically in the coming decades, said AbbVie, posing a considerable challenge to healthcare systems.

“Through building a strong, active pipeline, which is focused on significant unmet needs in eye care, AbbVie is committed to developing and delivering sustainable solutions that make a remarkable impact on people’s lives” the company stated.

Allergan in-licensed exclusive global rights to the candidate from Molecular Partners in 2012 in a deal worth up to $420M.

Shares in AbbVie are trading up 14% year-to-date, and the stock has a bullish Strong Buy Street consensus. Indeed out of 14 analysts covering the stock, only one is staying on the sidelines. Meanwhile the average analyst price target of $110 indicates 9% further upside potential lies ahead. (See ABBV stock analysis on TipRanks)

“Our investment thesis on ABBV is based on our view that the company will generate double-digit near-term growth on the back of P&L catch-up in 2021 and strength of core franchises” commented RBC Capital analyst Randall Stanicky.

He has a buy rating on the stock and $125 price target, arguing “While we see a step-down in 2023 upon HUMIRA biosimilar entry, it should be manageable with growth off of that trough year beyond. We do not think current valuation reflects that outlook and see upside to shares from here.”

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