After running into time delays with its sterile drug contract manufacturer, California-based Aerie Pharmaceutical has decided to take control of future production with its own manufacturing facility in Ireland.
The Irvine, CA-based biotech said Monday that it has an agreement with the Industrial Development Agency (IDA) of Ireland to lease a new manufacturing plant in Athlone. The biotech expects to invest about $25 million to build out and equip the 30,000-square-foot newly built shell. And if Rhopressa wins approval, the company said it could have commercial production coming out of the Ireland plant by 2020.
“As we prepare for commercialization, it is increasingly important that we ensure greater independence regarding our finished product sourcing while also meaningfully reducing our future product costs,” Aerie CEO Vicente Anido, Jr. said in a statement.
Aerie last fall had to withdraw its NDA for the eye drug after its Tampa,FL-based CMO said it would not have a manufacturing line ready for an FDA pre-inspection by year-end. It then had to postpone again in December when the CMO said the line would not be up and running until late February.
Other drugmakers, large and small, have faced delayed drug approvals in recent months because of manufacturing issues. Roche last month said the PDUFA date for its experimental drug for multiple sclerosis had been pushed off to March 28 from its original Dec. 28, 2016 date because the FDA needed more time to evaluate manufacturing info it had submitted.