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

Bristol-Myers Squibb Co (NYSE:BMY) and AstraZeneca plc (ADR) (NYSE:AZN) purchased Amylin Pharmaceuticals last year solely for the GLP-1 drugs Byetta and Bydureon. The latter received approval in January 2012, and Bristol-Myers Squibb Co (NYSE:BMY) only reported $66 million in sales for the second quarter this year.
A U.S. approval for Forxiga wouldn’t take all of the bumps out of the year ahead. But it would inspire greater confidence in the diabetes partnership.

But wait, there’s more…
The Amylin acquisition also included metreleptin, which treats an ultra rare metabolic condition called lipodystrophy that only affects a few thousand patients worldwide. Metreleptin has a PDUFA date of Feb. 27 after the FDA requested an additional three months to review the data.

A potential metreleptin approval ultimately has the same goals as Forxiga: win approval and make the AstraZeneca plc (ADR) (NYSE:AZN)-Bristol-Myers Squibb Co (NYSE:BMY) partnership appear more sound.

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.

The article 3 PDUFA Dates That Will Kick Off 2014 originally appeared on Fool.com is written by Brandy Betz.

Brandy Betz has no position in any stocks mentioned. The Motley Fool recommends BioMarin Pharmaceutical (NASDAQ:BMRN).

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