BioMarin Pharmaceutical Inc.(BMRN) announced that it is seeking Canadian approval for its enzyme replacement therapy, Vimizim (elosulfase alfa). The company has filed a new drug submission (:NDS) with Health Canada for the candidate under priority review status. BioMarin is looking to get the candidate approved for the treatment of patients suffering from the lysosomal storage disorder Morquio A syndrome.
Heath Canada reviews the marketing applications for those candidates on a priority basis that offer major advances in treatment and for which there exists significant unmet medical need. The procedure reduces the time taken to review the marketing application.
We expect Vimizim to be approved in the U.S. (target date: Feb 28, 2014). Last month, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAQ) of the FDA recommended the approval of Vimizim for the indication.
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).
Rumors of BioMarin being an attractive takeover target have been in the air with Vimizim nearing FDA approval. The orphan product portfolio at BioMarin has also contributed to the rumors. However, BioMarin's expensive valuation could prevent the transaction from materializing.
BioMarin, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space are Actelion Ltd. (ALIOF) and AMAG Pharmaceuticals, Inc. (AMAG). While Actelion carries a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).