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BMRN Seeks US Approval of Vimizim

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BioMarin Pharmaceutical Inc. (BMRN) recently submitted a Biologics License Application (:BLA) to the US Food and Drug Administration (:FDA) for Vimizim (BMN-110, elosulfase alfa). BioMarin is seeking US approval of the candidate, previously known as GALNS, for the treatment of patients suffering from mucopolysaccharidosis Type IVA (MPS IVA) or morquio A syndrome.

BioMarin’s BLA submission was based on positive results from a phase III study on Vimizim. Data from the study showed that there was a significant change in six-minute walk distance in comparison to placebo at the end of 24 weeks.

Data from the study also revealed an improving trend in three-minute stair climb and pulmonary function in patients treated with Vimizim compared to placebo, at the end of 24 weeks. Moreover, patients treated with Vimizim showed consistent and robust reduction in urinary keratan sulfate (KS) levels compared to placebo.

BioMarin intends to seek approval for Vimizim in the European Union (EU) for the same indication towards the end of this month.

We are pleased with BioMarin's efforts to develop its pipeline. Vimizim is the most important pipeline candidate at BioMarin. The company expects the candidate to be approved by the end of 2013. We believe that the company can swing to profitability in the event of Vimizim gaining approval.

We note that BioMarin has several data read-outs and trial initiations lined up this year. We expect investor focus also to stay on these results apart from the regulatory decision of Vimizim.

BioMarin currently carries a Zacks Rank #3 (Hold). However other biopharma stocks such as Athersys Inc. (ATHX), Cytokinetics Inc. (CYTK) and Array BioPharma Inc. (ARRY) currently look better positioned. While Athersys and Cytokinetics carry a Zacks Rank #1 (Strong Buy), Array carries a Zacks Rank #2 (Buy).

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