AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection

abbvie
(AbbVie)

When you spend $63 billion on a company, your hope is that investment will come back; sometimes, however, you get hit with problems.

AbbVie is learning that this week after its buyout of Allergan has seen, just a month after finalizing the deal with the Federal Trade Commission’s blessing, that one of the first drugs it might have hoped to get approved has been hit with a complete response letter.

The FDA slapped the CRL on AbbVie (and co-developer Molecular Partners) for Abicipar pegol, their experimental DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).

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The issue is safety: “The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of [wet AMD]. AbbVie plans to meet with the FDA to discuss their comments and determine next steps.” Similar safety concerns had been seen in some prior tests, so this may not be a major surprise.

Of course, AbbVie isn’t giving up on the drug. “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 Robinson, M.D., vice president and global therapeutic area head for ophthalmology at AbbVie.

“We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.” Still, this is, if you pardon the pun, bad optics a month after you sealed a $63 billion deal with a company partially focused on ophthalmology.  

The idea was that this drug could rival Roche’s Lucentis (ranibizumab) and Regeneron’s Eylea, two major blockbusters for this common eye disorder that can lead to blindness.

Last year, while still Allergan, it revealed data showing Abicipar pegol could in the longer term and with four injections maintain visual gains “comparable to monthly Lucentis.” While not excelling in efficacy, it was hoped the less frequent need for injections would be a unique selling point.

For now, the safety issues around those injections has put that in doubt. Either way, sell-side consensus only saw the drug making around $180 million a year, and, with biosimilars coming for Lucentis and Eylea now on the horizon, AbbVie will have a tough time squeezing much from the market.

It's a bigger hit for Molecular Partners, which penned a pact with Allergan for the drug all the way back in 2011, with around $1.5 billion in biobucks wedded to the deal. The Swiss biotech saw its shares plummet 40% on the news Friday morning.

The company will hope to have better luck with its COVID-19 drug, currently in early testing, which also uses its DARPin tech, along with its 2018 Amgen cancer drug collaboration, which has around $500 million in backloaded biobucks attached to it.

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