The company said it expects to incur between $225m (€164m) and $300m (€219m) in expenses through 2014 to expand its manufacturing capacity at its Rensselaer, NY, facilities, improve its other plants in Tarrytown, NY, as well as to purchase and renovate a new Limerick, Ireland plant, according to the Securities and Exchange Commission (SEC) filings.
Since 2007, Regeneron has collaborated with Sanofi to discover, develop, manufacture and commercialize fully human monoclonal antibodies with Regeneron's proprietary VelociSuite of technologies.
Sanofi has already paid $30m of agreed-upon costs incurred to expand the manufacturing capacity at the Rensselaer facilities.
Regeneron spokesman Peter Dworkin told BioPharma-reporter.com that the expansions will be for "a range of needs" including the manufacture of the candidate alirocumab. "The production parameters are different but the same facilities can and will be used to make the mAb," Dworkin said, referring to the fact that Regeneron already manufactures other biologics in-house, such as Eylea, a treatment for wet AMD.
Just this week, Regeneron announced that alirocumab significantly reduced LDL cholesterol when compared with Merck’s Zetia in a Phase III trial. The monocolonal antibody is the first of a new series of developing drugs, known as PCSK9 inhibitors, and could potentially earn as much as $3B annually, according to Reuters.
Earlier this summer, Regeneron agreed to acquire a 400,000 square foot facility in Limerick, Ireland, subject to securing permits from the local government in Limerick.
“We intend to renovate this facility to accommodate and support our growth, primarily in connection with expanding our manufacturing capacity to support our global supply chain,” the company said.
The company currently uses its Rensselaer facilities to produce bulk product of Arcalyst for the treatment of cryopyrin-associated periodic syndrome, bulk product of Eylea for the treatment of wet AMD and macular edema, bulk product of Zaltrap, as well as clinical and preclinical candidates.