As Eli Lilly rolls ahead with a $27 billion investment to prop up four new manufacturing facilities in the U.S, the company is moving to offload another plant with a checkered past.
Lilly plans to sell its production site in Branchburg, New Jersey, as part of a broader production overhaul at the company, a spokesperson confirmed with Fierce Pharma over email. The planned sale was first reported by Endpoints News.
“We have a long-term plan to deliver big bets on next-gen modalities, and we are currently leading the largest manufacturing expansion in Lilly’s history,” the spokesperson said of the decision. “Following a comprehensive assessment, we are repositioning our manufacturing operations to our new facilities to optimize future flexibility for our evolving pipeline.”
Lilly’s confirmation of the sale comes a little less than six months after the company telegraphed its $27 billion plan to grow its U.S. manufacturing footprint. Three of the four new plants Lilly has planned will produce active pharmaceutical ingredients (APIs), while the fourth will focus on injectable drugs.
Lilly has yet to reveal the locations of the future plants, but the company in February said it was in “negotiations with several states.” Some signs point to Houston as a potential host for one of the company’s new API facilities.
When all is said and done, Lilly expects the expansion project to generate more than 3,000 new roles in the U.S. The company has pledged to reveal the sites for its new plants later this year and aims to get them up and running within five years.
With the $27 billion investment announced in February, Lilly has brought its total manufacturing outlay in the U.S. to more than $50 billion since 2020. Much of that spending has been devoted to increasing capacity for the company’s immensely popular dual GIP/GLP-1 drug tirzepatide, which is approved in diabetes and obesity under the brand names Mounjaro and Zepbound, respectively.
Meanwhile, the Branchburg facility that Lilly is putting up for auction has landed in the FDA’s crosshairs multiple times since the start of the decade.
In one of the site’s most recent regulatory run-ins, FDA inspectors uncovered problems around process tracking, quality control, equipment calibration and overall facility maintenance during a July 2023 inspection.
The facility had ended up on the FDA’s radar after Lilly requested “additional flexibility” to produce its migraine med Emgality on a different production line, if needed, a company spokesperson told Fierce Pharma last year. The request triggered the FDA’s inspection, which ultimately resulted in the plant receiving a Voluntary Action Indicated (VAI) tag, the spokesperson said at the time.
That designation means the FDA found objectionable conditions or practices during its inspection but stopped short of taking formal administrative or regulatory actions.
Back in 2021, meanwhile, Branchburg employees accused an executive at the site of altering FDA-required documents in an effort to downplay quality control issues. In turn, the Justice Department handed Lilly a subpoena related to the site, which had been producing doses of the company’s COVID-19 antibody treatment at the time.
The company reportedly received another FDA write-up at the Branchburg facility around October 2022, and the site was also briefly implicated in a whistleblower lawsuit concerning alleged shortfalls in the manufacturing of the diabetes med Trulicity. Lilly settled the case in September 2023, Reuters reported at the time.
In Monday’s statement, the Lilly spokesperson did not note the potential value ascribed to the Branchburg facility or whether discussions with potential buyers were ongoing.