BioMarin Pharmaceutical Inc.’s (BMRN) stock price increased almost 8% when the U.S. Food and Drug Administration (FDA) released upbeat briefing documents ahead of the review by its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The FDA panel is scheduled to review the New Drug Application (NDA) for BioMarin’s Vimizim (elosulfase alfa), an enzyme replacement therapy, on Nov 19, 2013.
BioMarin is looking to get the candidate approved for the treatment of patients suffering from mucopolysaccharidosis Type IVA (MPS IVA) or morquio A syndrome. Vimizim has been granted priority review and a response from the FDA is expected by Feb 28, 2014.
The briefing documents posted by the FDA hinted at a favorable risk-benefit profile for the candidate. The document further says that on the basis of the available data treatment with Vimizim appears to be well tolerated in both the short as well as long term. Moreover, the safety profile of the candidate is also in line with other approved enzyme replacement therapies. The adverse reactions associated with the drug like hypersensitivity reactions are not uncommon to such therapies. The upbeat content of the documents further brightens the prospects of the drug gaining FDA approval in Feb 2014.
Apart from the upbeat briefing documents posted by the FDA on Vimizim, BioMarin received further encouraging news on the candidate with the French regulatory body issuing temporary clearance to Vimizim for treating MPS IVA patients. 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. The temporary authorization allows MPS IVA patients in France to be treated with Vimizim before the candidate is cleared in the EU.
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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