U.S. biotech opening plant in Ireland after issues with CMO delay glaucoma drug

Aerie Pharmaceutical has decided to build a manufacturing plant in Ireland for future production of its eye drug.

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.

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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.

Suggested Articles

Teva will produce its new migraine drug at a plant in Israel and more news of note.

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, nominee for FDA commissioner.

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.