BioMarin Pharmaceutical Inc. (BMRN - Analyst Report) received some encouraging news when the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) backed an extension for the company’s manufacturing facility in Novato, California.
A final decision by the EMA on the matter is expected in the first quarter of 2012. An EMA verdict in favor of the facility expansion would allow BioMarin to market the drugs manufactured there across the EU.
The successful extension of the facility would help BioMarin generate revenues up to $1.0 billion. The positive opinion of the CHMP comes close on the heels of the clearance of the expanded facility at Novato by the US Food and Drug Administration (FDA).
According to management, the EU clearance pf the facility expansion will help the company’s marketed drugs to fully realize their sales potential apart from supporting its expanding pipeline.
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, BioMarin purchased an integrated biologics manufacturing plant from Pfizer Inc. (PFE - Analyst Report) to expand its manufacturing capacity. The plant, purchased for a total purchase price of $50.4 million, is located in Shanbally, Cork, Ireland.
BioMarin’s product portfolio comprises four approved products and multiple pipeline candidates. The marketed products are Aldurazyme, Naglazyme, Kuvan and Firdapse.
BioMarin co-markets Aldurazyme with Sanofi (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 is available in the EU since April 2010 for treating patients suffering from Lambert Eaton Myasthenic Syndrome (LEMS) - a rare autoimmune disorder.
We currently have a Neutral recommendation on BioMarin. The stock carries a Zacks #3 Rank (short-term “Hold” rating).