With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds.
The investment will increase the capabilities of AZ’s manufacturing facility in Coppell, Texas, which is the company’s lone site in the world that produces Lokelma.
AZ will build a new 9,000-square-foot building at the complex and add two production lines, doubling its capacity to manufacture the treatment. The investment also will support upgrades for drug substance production and lab testing, as well as additional warehouse and administrative space, the company said in an Oct. 15 release.
“Our manufacturing facility in Coppell serves as both a critical pillar in global healthcare and has played an important role in supporting the local workforce over the past 10 years,” Jim Fox, AZ’s Americas supply operations chief, said in the release.
The outlay is part of AZ’s $50 billion investment in the United States over the next five years, which it unveiled earlier this year. Last week, the company broke ground on a $4.5 billion active pharmaceutical ingredient (API) facility near Richmond, Virginia.
AZ’s Texas facility, which employs 250 and is five miles north of Dallas Fort Worth International Airport, came under scrutiny when the FDA twice rejected applications for approval of Lokelma because of manufacturing issues.
The oral suspension treatment, which lowers the potassium levels in the blood, was finally approved in 2018, three years after AZ obtained it in a $2.7 billion buyout of ZS Pharma.
In the first half of this year, Lokelma generated sales of $328 million, which were up 31% year over year. A key competitor in the market is CSL’s Veltassa, which was approved a decade ago.