AstraZeneca plc (ADR) (AZN), Bristol-Myers Squibb Co (BMY), BioMarin Pharmaceutical Inc. (BMRN): Three PDUFA Dates That Will Kick Off 2014

BioMarin’s big drug’s day
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) has four approved products on the market and five in the pipeline. But Vimizim — formerly called GALNS — is the project that’s held investor attention. The drug treats a rare genetic condition called Morquio syndrome. Positive phase 3 results last year sent shares popping more than 30%. And more catalysts lurk right around the corner.

Vimizim will face a European Medicines Agency committee in the fourth quarter of 2013 for a potential approval recommendation. Then Vimizim is up for U.S. approval with a PDUFA date of Feb. 28. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) is ready for a quick domestic launch if given the go-ahead.

There’s currently no approved treatment for Morquio syndrome, which is why Vimizim received priority review status from the FDA. Vimizim provides a chance for BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to own this market.

That’s important because BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) specializes in orphan drugs and is better off with as many strong approved products as possible. The company can offset the small patient populations by dominating each market it enters and setting high prices for the drugs.

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)’s second-quarter loss was narrower than anticipated. And the company has more catalysts ahead including a phase 3 initiation for breast cancer drug BMN 673.

Foolish final thoughts
Out of the three drugs approaching PDUFA dates in the first quarter, Forxiga stands the greatest risk of being turned away. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) would take a greater hit than AstraZeneca plc (ADR) (NYSE:AZN) or Bristol if Vimizim wasn’t approved, but that drug has had a less troubled past.