New facility will greatly expand manufacturing capacity and diversify risk
Conference Call and Webcast to Be Held Today at 9:30 a.m. ET
Novato, CA /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today 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 programs."
Mr. 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."
Mr. 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 U.S. 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."
Conference Call Details
BioMarin will host a conference call and webcast to discuss the Shanbally acquisition today, Thursday, June 23, at 9:30 a.m. ET. This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
Date: June 23, 2011
Time: 9:30 a.m. ET
U.S. / Canada Dial-in Number: 866.713.8567
International Dial-in Number: 617.597.5326
Participant Code: 90826881
Replay Dial-in Number: 888.286.8010
Replay International Dial-in Number:
Replay Code: 97445483
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. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, amifampridine phosphate (3,4-diaminopyridine phosphate), which is currently in Phase III clinical development for the treatment of LEMS in the U.S., PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, and BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of the purchase of the Shanbally facility, and operational plans for the facility if acquired, and the continued developments of it product candidates. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: obtaining the transfer of the IPPC license from the Irish Environmental Protection Agency; results and timing of current and planned clinical and preclinical studies related to its product candidates; the success in transferring production to the new facility; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2010 Annual Report on Form 10-K, and the factors contained in BioMarin's reports on Form 10-Q. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
SOURCE: BioMarin Pharmaceutical Inc.