NOVATO, Calif.—BioMarin Pharmaceutical Inc. and Pfizer haveentered into a definitive agreement by which BioMarin will acquire a bulkbiologics manufacturing plant from Pfizer, based in Shanbally, Cork, Ireland.BioMarin will be purchasing the plant for $48.5 million, about a fifth of whatit would cost for the company to build and validate a new facility. The deal isexpected to close in the third quarter of 2011, pending the transfer of theIrish EPA license.
"The new plant in Shanbally greatly expands ourmanufacturing capacity to accommodate our growing commercial portfolio andadvancing clinical programs," said Jean-Jacques Bienaime, Chief ExecutiveOfficer of BioMarin, in a press release about the deal. "Our recently expandedmanufacturing facility in Novato, California is on track to receive approval bythe end of 2011 and can support approximately $1.0 billion in revenue. Webelieve that additional manufacturing capabilities beyond our current resourceswill 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 toprogress to approval, and our other preclinical programs."
The plant was completed and validated in 2009, a133,000-square foot facility built on 10 acres. It received approval from theIrish Medicines Board in 2010. BioMarin plans to have the plant occupied in aphased transition, with some manufacturing activities tied to results of thecompany's Phase III clinical study for N-acetylgalactosamine 6-sulfatase(GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known asMorquio A Syndrome). The company anticipates maintenance expenses of about $4million a year, and expects the facility to be licensed for GALNS production by2015. Bienaime noted that the facility "diversifies our manufacturing risk andprovides us with an attractive business environment."
The facility is state-of-the-art, utilizing disposabletechnology and flexibly designed and will allow us to run either fed batch orperfusion processes," said Bienaime. "This gives us tremendous latitude for thetypes of products that can be produced at the plant and allows us to focusefforts on the technical transfer of our next commercial product into thefacility."
In a press release about the deal, Barry O'Leary, ChiefExecutive of the Irish Investment and Development Agency (IDA Ireland), calledthe acquisition "a strategically important development for BioMarin," as itmarks the first of BioMarin's internal production activities to be basedoutside the U.S. O'Leary noted that this acquisition follows the establishmentof "an international supply chain and logistics presence in Dublin earlier thisyear," and added that "it is hoped that this investment will create over 100high quality jobs in the next five years."
"I am delighted to welcome BioMarin, a leading globalbiopharmaceutical company, to Ireland and look forward to working closely withthe company as it develops its operations here," O'Leary said.
BioMarin specializes in the development andcommercialization of biopaharmaceuticals for serious diseases and medicalconditions. The company's product portfolio includes drugs for the treatment ofmucopoysaccharidosis VI (MPS VI), mucopolysaccharidosis I (MPS I),phenylketonuria (PKU) and Lambert Eaton Myasthenic Syndrome. BioMarin also haveseveral product candidates in its pipeline, in Phases I to III, for thetreatment of MPS IVA, LEMS, PKU, Pompe disease and genetically defined cancers.