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BioMarin Pharmaceutical Inc. (BMRN - Analyst Report) received some encouraging news when the US Food and Drug Administration (FDA) cleared an extension to the company’s manufacturing facility in Novato, California.

The extension of the facility has doubled the manufacturing capacity at BioMarin. Following the expansion, management stated that revenues up to $1.0 billion can be generated via production at the facility.

BioMarin intends to use the expanded facility to produce GALNS, for treating MPS IVA, a rare genetic enzyme deficiency disorder, on approval. GALNS is currently in phase III study with top line results expected in the second half of 2012. Management believes that the expanded facility will not only help the marketed products at BioMarin achieve peak sales but also facilitate the pipeline development.

We note that BioMarin has been constantly on the lookout to expand its manufacturing capacity in order to support its product portfolio and robust pipeline. Earlier in the year, the company purchased an integrated biologics manufacturing plant from Pfizer Inc. (PFE - Analyst Report) to expand its manufacturing capacity. The plant, purchased for approximately $48.5 million, is located in Shanbally, Cork, Ireland and is spread across 133,000 square feet.

BioMarin’s product portfolio comprises of four approved products and multiple pipeline candidates. The marketed products are Aldurazyme, Naglazyme, Kuvan and Firdapse.

BioMarin co-markets Aldurazyme with Sanofi-Aventis (SNY - Analyst Report) for the treatment of MPS-I (mucopolysaccharidosis). Naglazyme is marketed for treating MPS-VI. Kuvan is marketed for treating patients suffering from phenylketonuria. Firdapse, added to BioMarin’s portfolio through the October 2009 acquisition of Huxley Pharmaceuticals, was launched in the EU in April 2010 for treating patients suffering from Lambert Eaton Myasthenic Syndrome (LEMS) - a rare autoimmune disorder.

Our Recommendation

We currently have a Neutral recommendation on BioMarin. The stock carries a Zacks #3 Rank (short-term “Hold” rating).

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