Gil Roth06.24.11
BioMarin Pharmaceutical has agreed to acquire 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 sq. ft. of floor space. It was approved by the Irish Medicines Board in 2010. The purchase is expected to close in 3Q11 following the wind-down of current operations and the transfer of the Irish EPA license.
The plant will be occupied in a phased transition with substantial manufacturing activities being tied to results of the ongoing Phase III trial for N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome).
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. In a press statement, BioMarin noted that the purchase price is approximately one-fifth of the expected cost to construct and validate a new facility.
Jean-Jacques Bienaime, chief executive officer of BioMarin, remarked, "The new plant in Shanbally greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs. Our recently expanded manufacturing facility in Novato, CA 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."
He added that the Shanbally facility diversifies BioMarin's manufacturing risk and provides it with an attractive business environment. "The facility uses disposable technology and is flexibly designed and will allow us to run either fed batch or perfusion processes. This gives us tremendous latitude for the types of products that can be produced at the plant and allows us to focus efforts on the technical transfer of our next commercial product into the facility," Mr. Bienaime noted.
The plant will be occupied in a phased transition with substantial manufacturing activities being tied to results of the ongoing Phase III trial for N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome).
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. In a press statement, BioMarin noted that the purchase price is approximately one-fifth of the expected cost to construct and validate a new facility.
Jean-Jacques Bienaime, chief executive officer of BioMarin, remarked, "The new plant in Shanbally greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs. Our recently expanded manufacturing facility in Novato, CA 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."
He added that the Shanbally facility diversifies BioMarin's manufacturing risk and provides it with an attractive business environment. "The facility uses disposable technology and is flexibly designed and will allow us to run either fed batch or perfusion processes. This gives us tremendous latitude for the types of products that can be produced at the plant and allows us to focus efforts on the technical transfer of our next commercial product into the facility," Mr. Bienaime noted.
