The US BioPharma has confirmed it is in late-stage talks to acquire a 400,000 sqft facility in Limerick from computer manufacturer Dell, which has been looking for a buyer since announcing it planned to shift production to a plant in Poland in 2009.
Regeneron spokesman, Peter Dworking, told BioPharma-Reporter.com that: “Subject to a definitive agreement with the seller and the necessary permits from local governments, we will refurnish the facility for biologics production, QA/QC, and related functions to make our monoclonal antibodies [MAb].
“The Irish facility will be in addition to our current industrial operations and product supply operation in Rensselaer, NY, near Albany,” he explained, adding that “the Ireland facility will provide additional capacity for product supply to satisfy commercial demand for our products.”
Dworking added that while US capacity is sufficient for Regeneron’s approved products – the MAbs Eylea, Arcalyst and Zaltrap – the firm is “expanding our plant in Rensselaer to have adequate capacity to make drug material both for clinical trials and for commercial sales.”
The proposed Irish acquisition will play a similar role according to Dworking, particularly if any of the late-stage clinical candidates in the BioPharma firm’s pipeline go on to receive marketing approval from regulators.
“The Irish plant, when on line, will provide still more capacity for commercial products. In particular, we will need more commercial capacity if drugs we have in Phase III clinical trials for rheumatoid arthritis and cholesterol management successfully complete these trials and are approved by regulatory agencies in the US, Europe, and Asia. “
Similarly, if any approved drugs are cleared for new indications – specifically the eye drug Eylea which is in Phase III trials for diabetic macular edema – Regeneron plans to use the additional capacity at the Irish plant to increase production.
Dworking declined to comment on whether the new plant will supply German drugmaker Bayer, for which Regeneron currently produces Eylea for the European market.