FDA Approves BioMarin's Manufacturing Facility Located in Shanbally, Cork, Ireland

Ongoing Expansion of Facility Furthers Commitment to Irish Manufacturing  

SAN RAFAEL, California, June 12, 2017 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today The Food and Drug Administration (FDA) has approved a bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance (N-acetylgalactosamine 6-sulfatase (GALNS) used in the production of Vimizim® (elosulfase alfa) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome).

The plant, which was acquired from Pfizer in 2011, is built on twenty acres occupying 200,000 square feet of floor space. The plant was certified by the Health Products Regulatory Authorities (HPRA) on behalf of the European Medicines Agency (EMA) in Q1 2017.  The plant has been licensed by FDA for a range of activities including bulk production, QC testing, QA release, final product secondary packaging (labeling and packaging) and distribution.

In addition, BioMarin is completing construction on a number of expansion projects at the facility to allow for continued growth at the site and to maximize the flexibility and operational capacity of this important asset.  These projects included an expanded warehouse, new office space and improved and expanded utilities.  During this construction, BioMarin has engaged the services of local workers to complete these projects. 

Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin stated, "The Shanbally plant greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs, as well as diversifies manufacturing risk associated by now having two licensed facilities. In addition, it provides flexibility and capacity for our largest and fastest growing commercial product, Vimizim, to meet projected demand for the foreseeable future.  The flexible state-of-the-art facility gives us tremendous latitude for the types of products that can be produced at the facility."

Martin Shanahan Chief Executive Officer of IDA Ireland said: "BioMarin has made a substantial commitment to manufacturing in Ireland since acquiring their Cork facility in 2011. BioMarin's development of treatment options for ultra-orphan rare diseases represents the type of innovative science that IDA wishes to attract to Ireland.  The south west region offers local workers an excellent quality life and the local economy has in turn benefitted significantly from the company's investment. Today Ireland continues to be viewed as the ideal location for biopharmaceutical companies looking to grow their operations, with a highly educated workforce and an excellent track record. I am confident that BioMarin will continue to thrive and grow in Ireland over the coming years."

Robert Baffi, Executive Vice President of Technical Operations stated, "The first cycle approval of this facility by FDA is a testament to our capabilities and thorough understanding of facility design and regulatory requirements involved in the tech transfer and production of one product at two different manufacturing facilities.  Our experience in the design, construction and approval of multi-product manufacturing plants is a hallmark of BioMarin's success and technical prowess.  As we continue to grow, we are looking to hire the best and brightest in a variety of disciplines in Shanbally."

About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The Company's portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.BioMarin.com.

Forward-Looking Statement
This press release contains forward-looking statements, including, without limitation, statements regarding the FDA approval of the Shanbally manufacturing facility and the manufacturing of Vimizim.  These forward-looking statements are based on the Company's current beliefs and expectations and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others, risks related to: further actions by regulatory authorities, including the FDA and EMA,; the commercialization of Vimizim; and the Company's ability to manufacture sufficient quantities of Vimizim; the market potential for Vimizim as a treatment for MPS IVA; competitive developments; the Company's ability to successfully transfer additional the manufacturing of other products to the Shanbally facility; and those other risks detailed from time to time under the caption "Risk Factors" and elsewhere in the Company's Securities and Exchange Commission (SEC) filings, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, and future filings and reports by the Company. The Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

BioMarin® and Vimizim® are registered trademarks of BioMarin Pharmaceutical Inc.

Related Links

http://www.biomarin.com