Working alongside the Industrial Development Agency (IDA) in Ireland, the California-based biotech has settled on a site in Athlone, which it claims will be ready for commercialisation of the small molecule Rhopressa by 2020.
Rhopressa is Aerie’s ophthalmic solution of small-molecule netarsudil to treat Glaucoma - a group of degenerative eye diseases that can lead to vision loss.
Aerie has also developed a second Phase III product – Roclatan – currently in two trials combining Rhopressa with an FDA-approved small-molecule generic, latanoprost.
Aerie withdrew its new drug application (NDA) for Rhopressa in October after its Tampa, Florida-based contract manufacturing organisation (CMO) announced it would not be ready for US FDA inspection.
Following further delays, Aerie has said it will now resubmit the NDA next month, and if successful, both Rhopressa and Roclatan will be manufactured at the Athlone facility instead.
“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,” said Vicente Anido, CEO of Aerie.
Ireland facility
The building shell was initially constructed by the IDA in the Athlone Business and Technology Park, around 130km from Dublin.
Aerie will now lease the space with internal construction with equipment purchase to begin immediately.
Projected costs are expected to total $25M, excluding the lease.
In a statement, the firm claims its move to manufacture in Ireland was also based on some incentives set by the IDA, including employment and capital investment.
Anido added “We are grateful to our IDA colleagues in Ireland for their cooperation throughout this process and the incentives that we have been granted.”
US FDA inspection
Aerie withdrew their NDA submission of Rhopressa in October after its CMO announced it would not be ready for its FDA pre-approval inspection of the facility in Tampa, Florida.
A second delay in December was announced by the unnamed CMO, further pushing back plans to commercialise the drug.
In a statement, the Aerie decided it would re-submit the NDA this February, with plans to submit a marketing authorisation application (MAA) for Rhopressa to the EMA by the end of 2017.
Aerie and the IDA were not available for comment.