BioMarin Pharmaceutical Inc. announced that it has entered into a definitive agreement to acquire a bulk biologics manufacturing plant from Pfizer, located in Shanbally, Cork, Ireland. The plant, which was completed and validated in 2009, is built on ten acres occupying 133,000 square feet of floor space. It was approved by the Irish Medicines Board in 2010. The purchase price is $48.5 million, approximately one-fifth of the expected cost to construct and validate a new facility. The purchase is expected to close in the third quarter of 2011 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 3 clinical study for N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome). In the meantime, 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.
Jean-Jacques Bienaime, chief executive officer of BioMarin stated, "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, 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 programmes."
Bienaime continued, "The new facility in Shanbally also diversifies our manufacturing risk and provides us with an attractive business environment. 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. 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."
Barry O'Leary, chief executive of the Irish Investment and Development Agency (IDA Ireland), welcomed the investment, saying, "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. The decision to acquire the Shanbally plant is a significant endorsement of Ireland's wealth of talent and expertise and it is hoped that this investment will create over 100 high quality jobs in the next five years."
O'Leary continued, "Ireland has a long, successful track record of attracting significant pharmaceutical investment from multinationals. We have now established Ireland as the second largest development and manufacturing location in the world for biopharmaceuticals, after the US. I am delighted to welcome BioMarin, a leading global biopharmaceutical company to Ireland and look forward to working closely with the company as it develops its operations here."
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates.