Shire opened a new $1 billion plant in the U.S. in October, and the first product that will come out will be its immune deficiency treatment Gammagard Liquid. But given the long lead time needed to produce and deliver the rare disease drug to the market, a tight supply is projected to continue through this year.
Takeda, which completed its $58 billion buyout of Shire in January, says it is committed to dealing with the shortage. In addition to opening the new plant near Covington, Georgia, it boosted its plasma collections 21% last year and is looking at buying plasma from third parties.
“As a result of the manufacturing time required to produce Gammagard Liquid combined with growing demand, we are experiencing Gammagard Liquid supply tightness that will likely persist throughout 2019,” Takeda said in an email.
The 1-million-square-foot plant with 850 employees will provide a big boost in supplies, but given it takes 7 to 12 months to manufacture and supply customers with the plasma-derived product, Takeda said that “quick shifts based on demand trends are often not feasible, especially in time of constraints.”
It has taken some years to get the plant open, and it has gone through multiple owners during the process. The facility was announced in 2012 when Baxalta was still the drug unit of Baxter International. Baxter spun the drug unit off into Baxalta in 2014, and Shire bought Baxalta in a $32 billion deal in 2016 in a move to broaden its offerings. The plant ended up as part of Takeda with its buyout of Dublin-based Shire.
The company intends to make a variety of immunoglobulin products there targeted at primary immune deficiency disorders. In March, it received FDA approval to make Flexbumin 25% at the plant.