BioMarin Pharmaceutical Inc. (BMRN) continued to receive encouraging news on its enzyme replacement therapy Vimizim (elosulfase alfa), when the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the drug’s approval in the EU for treating patients suffering from mucopolysaccharidosis type IVA (MPS IVA).
The positive development came a week after the U.S. Food and Drug Administration (FDA) cleared the drug for the same indication. The encouraging news from Europe impressed the investors with the stock gaining 4.95% on the news.
EU- A Key Market For Vimizim
The positive opinion of the CHMP will now be reviewed by the European Commission (EC). A decision from the EC on Vimizim is expected within the next 2 months. After receiving clearance for the drug in the U.S., BioMarin had said that gaining EU approval was important since the U.S. accounted for only 15% of the 1,500 MPS IVA patients identified by BioMarin.
Consequently, a favorable EC decision on Vimizim will go a long way in boosting the drug’s sales potential. Moreover, EU approval would make Vimizim the first therapy in the EU for the treatment of this rare genetic disorder
BioMarin is also looking to get Vimizim approved for MPSIVA in other markets as well such as Brazil, Australia, Canada and Mexico. Approval in these markets will increase the drug’s contribution to BioMarin’s top line. Only U.S. approval for Vimizim will not make it a meaningful contributor to the biopharmaceutical company’s total revenues due to the limited target population and the presence of a boxed warning in the drug’s label to include the risk of anaphylaxis as its infusion of resulted in life-threatening anaphylactic reactions in some patients during clinical trials.
High Hopes on Vimizim at BioMarin
Management at BioMarin is bullish on the potential offered by Vimizim. Strong Vimizim sales are expected to help the company record total revenues in excess of $1 billion for the next few years. The company projects Vimizim sales in 2014 in the range of $60 million–$70 million with about 350 patients on therapy by year end. We expect the company to easily achieve its 2014 sales guidance on Vimizim. The company has priced the drug in the U.S. at about $380,000 (net) annually for a typical MPS IVA patient.
Following FDA approval, Vimizim has become the fifth member of BioMarin’s product portfolio. The other marketed products of the company are Naglazyme, Kuvan, Aldurazyme and Firdapse. BioMarin co-markets Aldurazyme with Sanofi (SNY). Buoyed by the addition of Vimizim to its product portfolio, BioMarin announced earlier in the week that it expects its total revenues in 2014 to increase by more than 20% over the 2013 preliminary revenue figure ($548.5 million). The biopharmaceutical company expects 2014 revenues in the range of $650–$680 million.
Apart from the strong product portfolio, BioMarin has a robust pipeline with several data readouts expected this year. We expect investor focus to remain on Vimizim’s commercialization as well as BioMarin’s pipeline going forward.
BioMarin currently carries a Zacks Rank #3 (Hold). Better-ranked biopharma stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences, Inc. (GILD). While Alexion carries a Zacks Rank #1 (Strong Buy), Gilead holds a Zacks Rank #2 (Buy).
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