AbbVie hands back headline drug in $63B Allergan buyout to Molecular Partners after FDA rejection. What's next?
One of the programs that headlined AbbVie’s $63 billion acquisition of Allergan is being returned to its developers after an FDA rejection last year.
AbbVie has terminated the license and collaboration agreement it had with Switzerland’s Molecular Partners for abicipar, the companies announced Monday, an experimental drug aimed to treat neovascular age-related macular degeneration and diabetic macular edema. Abicipar was rejected by the FDA in June 2020 due to what AbbVie said was an unfavorable benefit-risk ratio, according to its description of the CRL.
Molecular Partners’ stock $MOLN was down about 4% on the Swiss stock exchange in the wake of Monday’s news.
In order to determine next steps for the program, Molecular Partners said in a release that it will establish a “special committee.” Company spokesperson Seth Lewis told Endpoints News in an interview that the committee will likely be composed primarily of internal staffers but may bring on outside expertise “as needed.”
Lewis further emphasized that future plans are still in the nascent stage, given that Molecular Partners only received notification of the termination Monday. The company has yet to receive all the materials associated with the program, with Lewis saying Allergan had essentially owned the program outright and made all major decisions.
While Molecular Partners had been kept informed of the program’s progress, Lewis attempted to distance the biotech from Allergan, saying the relationship between the companies has “ebbed and flowed” in the years since licensing abicipar back in 2011. Lewis stressed that since that time, Molecular Partners had built out a portfolio largely unrelated to ophthalmology.
Other programs are not expected to be affected by the termination, as the release noted that the companies will continue partnering on ophthalmic indications.
Abicipar had been expected to play a big part in the famed Allergan buyout and challenge the Roche drug Lucentis and the Regeneron giant Eylea, with former Allergan CEO Brent Saunders saying back in May 2019 the program was one of four “expected” to gain FDA approval. The candidate had passed two Phase III tests a year earlier, as Allergan touted both eight- and 12-week regimens.
But those studies also flagged that the incidence of intraocular inflammation proved higher in patients on abicipar than those on Lucentis, which regulators took issue with in the CRL, Lewis said. Allergan had conducted a separate open-label, single-arm study around the same time as the Phase III trials, showing new manufacturing processes appeared to have led to a lower rate of inflammation.
That study was not included in the pivotal program, however. The intraocular inflammation rate in this trial was 8.9%, or around numerically half the rate observed in prior Phase III studies, which hovered around 15%. Lewis said the threshold the FDA is looking for is around 5%, and another pivotal study looking at further lowered rates could be in the cards.
“If you think about the history of Allergan, they were a great commercial company when we did the deal with them back in 2011, and it was very exciting to be able to do that, but their knowledge of biological manufacturing wasn’t that great at the time,” Lewis told Endpoints. “The knowledge and increased efficacy of process that’s been built up over that time should allow for continued improvements.”