BioMarin Pharmaceutical Inc. (BMRN) received encouraging news when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the company’s enzyme replacement therapy Vimizim (elosulfase alfa).
BioMarin is looking to get the candidate approved for the treatment of patients suffering from mucopolysaccharidosis Type IVA (MPS IVA) or morquio A syndrome. BioMarin stated in its press release that of the 21 members in the advisory, all but 1 voted in favor of Vimizim’s approval. While 19 members recommended the approval of the drug for treating all MPS IVA patients, a sole panel member voted in favor of approving the drug for treating a subgroup of patients suffering from the disease.
A final decision from the FDA on the matter is expected by Feb 28, 2014. We note that the FDA is not bound to accept the recommendation of the panel. The U.S. regulatory body, however, considers the panel’s recommendation while deciding on the fate of a candidate. We expect the drug to be approved by the FDA.
Vimizim is also under review in the EU. An opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use is expected by late 2013/early 2014.
Vimizim, on approval, would boost BioMarin’s top line significantly. The product portfolio at BioMarin currently has four marketed products – Naglazyme, Kuvan, Aldurazyme and Firdapse. BioMarin co-markets Aldurazyme with Sanofi (SNY).
BioMarin currently carries a Zacks Rank #3 (Hold). Companies like WuXi PharmaTech (Cayman) Inc. (WX) and Pharmacyclics Inc. (PCYC) appear to be more attractive. WuXi Pharma carries a Zacks Rank #1(Strong Buy) while Pharmacyclics is a Zacks #2 Ranked company.
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