Facility will expand manufacturing capacity and diversify risk.
BioMarin Pharmaceutical is acquiring a bulk biologics manufacturing plant from Pfizer, located in Shanbally, Cork, Ireland, for $48.5 million. The plant, which was completed and validated in 2009, is built on 10 acres occupying 133,000 square feet of floor space. It was approved by the Irish Medicines Board in 2010.
BioMarin points out that the purchase price is approximately one-fifth of the expected cost to construct and validate a new facility. The plant will be occupied in a phased transition with substantial manufacturing activities being tied to results of the ongoing Phase III study for N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of mucopolysaccharidosis IVA (MPS IVA).
Maintenance expenses for the facility are expected to be approximately $4 million a year. It is anticipated that the facility will be licensed for GALNS production by 2015. “The new plant in Shanbally greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs,” comments Jean-Jacques Bienaime, CEO of BioMarin.
“Our recently expanded manufacturing facility in Novato, California is on track to receive approval by the end of 2011 and can support approximately $1.0 billion in revenue. We believe that additional manufacturing capabilities beyond our current resources will be needed to support anticipated peak sales for GALNS, PEG-PAL for PKU, BMN 701 for Pompe disease, BMN 111 for achondroplasia, if they continue to progress to approval, and our other preclinical programs.”
PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) is an investigational enzyme substitution therapy for the treatment of phenylketonuria (PKU) currently in Phase II. BMN 701, which is in Phase I testing, has the ability to bind to key cell receptors that direct the enzyme to the cell’s lysosome for the treatment of Pompe disease.
BMN 111 is at the preclinical stage. It is a stabilized version of C-type natriuretic peptide, a natural human peptide that is a positive regulator of bone growth; achondroplasia is a result of an autosomal dominant mutation in the fibroblast growth factor receptor 3 gene (FGFR3), which causes an abnormality of cartilage and bone formation.
“The new facility in Shanbally also diversifies our manufacturing risk and provides us with an attractive business environment,” Bienaime adds. “The facility is state-of-the-art, utilizing disposable technology, and flexibly designed and will allow us to run either fed-batch or perfusion processes.”
Barry O’Leary, CEO of the Irish Investment and Development Agency (IDA Ireland), remarks, “This is a strategically important development for BioMarin as it is the first time the company has placed internal biopharmaceutical production activities outside of the U.S. This is the next phase in BioMarin’s expansion into Ireland’s life sciences industry, following the establishment of an international supply chain and logistics presence in Dublin earlier this year.”