BioMarin Pharmaceutical Inc. (BMRN) recently submitted a marketing application (MA) for its candidate, Vimizim to the Agencia Nacional de Vigilancia Sanitaria (:ANVISA) – the Health Surveillance Agency of Brazil. BioMarin expects the agency to review the MA on a priority basis. A decision is expected in mid 2014.
BioMarin is looking to get Vimizim – an enzyme replacement therapy – approved for treating patients suffering from mucopolysaccharidosis type IVA (MPS IVA) – a rare lysosomal storage disorder.
The candidate is under priority review in the US (target date: Feb 28, 2014) for the same indication. Vimizim is also under review in the EU. The Marketing Authorization Application for Vimizim had been granted accelerated assessment status by the European Medicines Agency. Consequently, BioMarin expects a decision on Vimizim in the EU in the first quarter of 2014. The candidate enjoys orphan drug status in the US as well as in the EU.
Vimizim is one of the most interesting candidates in BioMarin’s pipeline. We expect investor focus to stay on the regulatory updates regarding Vimizim. Positive news from the regulatory agencies on the candidate would further strengthen the company’s product portfolio.
BioMarin’s product portfolio already includes Aldurazyme, Naglazyme, Kuvan and Firdapse. Aldurazyme, co-marketed with Sanofi (SNY), is available for the treatment of MPS-I (mucopolysaccharidosis). Naglazyme is marketed for treating MPS-VI. Kuvan is marketed for phenylketonuria. Firdapse is marketed for treating patients suffering from Lambert Eaton Myasthenic Syndrome.
BioMarin currently carries a Zacks Rank #3 (Hold). However, companies such as Alnylam Pharmaceuticals, Inc. (ALNY) and Incyte Corporation (INCY) appear attractive. While Alnylam carries a Zacks Rank #1 (Strong Buy), Incyte carries a Zacks Rank #2 (Buy).
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