Another day, another biopharma expansion on the Emerald Isle: Following a spate of Irish pharma growth this summer, Horizon Therapeutics is getting in on the action.
Horizon has submitted a planning application to grow its development and manufacturing facility in Waterford, Ireland, the rare and rheumatic disease specialist said Monday. The move, designed to load new drug substance biologics development and manufacturing firepower, will add another 320,000 square feet to the plant’s existing 44,000-square-foot fill-finish facility. The upgrade is expected to create around 350 new jobs “over time,” Horizon said.
The company did not lay out a financing figure for the project, noting that it "anticipates providing additional details with respect to potential investment and timeline as the planning application process proceeds.”
Horizon bought its Waterford facility last June for $65 million. Horizon locked in the purchase with the understanding that nearby land was available for further manufacturing and development expansion, the company pointed out.
As work with Irish and U.S. regulators rolls on, Horizon expects to obtain licensure for sterile-fill finish production and anticipates the first medicine to be approved for release from the existing facility in 2023.
Both the current plant and the upcoming amenities will be used for Horizon’s commercial rare disease biologics as well as drugs still in development, the company said.
“As we grow as a global biotechnology company, it is important to continue to invest in our development and manufacturing capabilities to supplement our current network of contract manufacturing organizations to maintain flexibility over our production and supply,” Tim Walbert, Horizon’s CEO, said in a statement.
While Horizon didn't lay out specifics on the drugs it plans to produce at the upgraded Waterford plant, boosted manufacturing flexibility could help the company circumvent future hurdles like those it faced on thyroid eye disease med Tepezza in December 2020. That month, it came to light that the U.S. had drafted Horizon’s manufacturing partner Catalent into COVID-19 vaccine service through the Defense Production Act, forcing the CDMO to liquidate planned Tepezza manufacturing slots.
Around six months later, Tepezza managed to rebound, Jefferies analysts wrote at the time, suggesting the med had regained its pre-pandemic momentum following its Feb. 2020 launch.
For all of 2021, Tepezza pulled down $1.66 billion, growing a staggering 103% year over year. In its annual report, Horizon noted that Tepezza’s performance was nothing short of “remarkable” given that “commercial supply was disrupted from late 2020 into April 2021.”
Horizon touted a “strong commercial relaunch” after Tepezza supplies recovered, which helped the company get "patients on therapy quickly as Horizon continued to increase uptake of the medicine.”
To further support its Tepezza franchise, Horizon last year doubled its commercial organization for the drug and added a second manufacturer to bring additional capacity online, the company explained in its earnings report.
Horizon will be in good company as it bulks up in Ireland. Just last week, Merck & Co. said it was laying out 100 new jobs as part of an expansion at its Irish manufacturing campus in Carlow. Alongside the staff-up, the company—known as MSD outside the U.S. and Canada—is revving up construction of a new on-site facility focused on oncology biologics. The plant currently employs around 530 staffers.
Earlier this summer, meanwhile, Merck & Co.’s eponymous German rival Merck KGaA said it would invest 440 million euros (about $469.3 million) to boost membrane manufacturing capacity in Carrigtwohill and build a new filtration manufacturing plant at Blarney Business Park, both of which are in Cork, Ireland. The project, expected to wrap up by the end of 2027, will bolster Merck KGaA’s workforce by around 370, the company said in May.
On the medtech front, Abbott and Stryker have also charted recent expansions on the Emerald Isle.