BioMarin Pharmaceutical Inc.
) 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
BioMarin intends to seek approval for Vimizim in the European
Union (EU) for the same indication towards the end of this
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
BioMarin currently carries a Zacks Rank #3 (Hold). However
other biopharma stocks such as
Array BioPharma Inc.
) 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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