The deal extends AbbVie’s commitment to the psychedelics space and depression, after emraclidine’s high-profile flop in schizophrenia last November.
Not only is AbbVie jumping back into depression after a stunning failure last year, but the company is doing so with an eye-catching modality: psychedelics. After working closely with Gilgamesh Pharmaceuticals for over a year, AbbVie will buy the neuroscience biotech’s lead depression candidate for $1.2 billion.
The deal was announced Monday morning, with AbbVie splitting the cash between an upfront payment and development milestones, which were not disclosed. The transaction will only include Gilgamesh’s lead asset, bretisilocin, which was not involved in the companies’ original May 2024 licensing partnership. The drug is being developed as a fast-acting, two-hour duration treatment option for major depressive disorder (MDD).
The remaining assets in Gilagmesh’s stable—including those in the existing AbbVie collaboration—will be spun out into a new company called Gilgamesh Pharma Inc. This new entity will hold all of Gilgamesh’s employees and programs, which include an oral NMDA receptor antagonist called blixeprodil, a cardio-safe ibogaine analog and an M1/M4 agonist program.
AbbVie will still have an option to license candidates from the new Gilgamesh entity, according to the terms of the original deal.
The deal extends AbbVie’s commitment to the psychedelics space, one of the only Big Pharmas in the game. The other major player is Johnson & Johnson, which owns the esketamine-based Spravato, though the company has told BioSpace it doesn’t consider the depression drug to be a traditional psychedelic.
AbbVie was cautious with the deal, reflecting the lower-than-expected valuation for the Gilgamesh asset, BMO Capital Markets said in a note Monday morning.
“We believe the lower deal value could reflect conservatism around psychedelic valuations in light of regulatory backdrop for compounds, making today’s deal a well-balanced risk/reward acquisition for the company,” BMO’s Evan David Seigerman and colleagues wrote.
Still, the deal reflects a vote of confidence in the psychedelics space.
“Historically, large pharma has been less active exploring psychedelic compounds due to potential regulatory concerns surrounding approval, making today’s deal more significant, starting to validate that pharma could see a therapeutic outlet for some of these drugs,” BMO’s note read.
And the deal makes sense for AbbVie, the analysts added, noting its existing neuroscience portfolio that features the MDD asset Vraylar. Others in the portfolio include Ubrelvy and Qulipta, which BMO said are under-appreciated compared to AbbVie’s headline-making immunology drugs Skyrizi and Rinvoq.
Taking on Gilgamesh’s depression asset means that AbbVie is taking another shot at the condition after the failure of emraclidine. That asset was picked up at the end of 2023 in the nearly $9 billion acquisition of Cerevel Therapeutics but ultimately failed two Phase II trials last November.
Meanwhile, a rival asset called Cobenfy from Bristol Myers Squibb’s acquisition of Karuna Therapeutics made its way to the market as the first new schizophrenia treatment in 35 years. In recent months, the drug has struggled to live up to expectations, failing a Phase III test testing it as an add-on treatment to atypical antipsychotics for schizophrenia.
AbbVie will now take over development of bretisilocin, a short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser, which is being tested in a Phase II trial for moderate-to-severe MDD. In Phase IIa data revealed in May, bretisilocin beat a low-dose psychoactive comparator in reducing symptoms of depression. The drug showed a rapid onset within 24 hours, and the results were durable out to day 74 without additional treatment. BMO called the data impressive.
At the time, Gerard Sanacora, professor of Psychiatry at Yale University and the director of the Yale Depression Research Program, compared the treatment to J&J’s Spravato, which achieves rapid results in the clinic.
“The treatment fits nicely in the two-hour in-clinic framework established by esketamine, but with the potential for significantly fewer annual visits,” Sanacora said in a statement included in Gilgamesh’s May 27 release.
