Johnson & Johnson (JNJ) Invokana PDUFA Preview: AstraZeneca plc (ADR) (AZN), Bristol Myers Squibb Co. (BMY)

Market competition: The field
Being first in class doesn’t automatically make a drug king, but being first to market sure helps. Merck (NYSE:MRK)’s Januvia was the first DPP-4 inhibitor approved for type 2 diabetes and is now the most well-established therapy. The franchise recorded $5.75 billion in worldwide sales in 2012. And despite Forxiga’s woes, the alliance between Bristol Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (ADR) (NYSE:AZN) isn’t exactly out of the race, either. The Byetta franchise, acquired from Amylin Pharmaceuticals last August, brought in $227 million in 2012.

Usually, doctors hesitate to prescribe new drugs as first-line therapies in light of a smaller body of safety data. That would seem to bode well for Januvia and Byetta, except for a recent study that found patients taking either drug were twice as likely to develop pancreatitis, a potentially lethal condition. The study puts a smudge on Januvia’s squeaky-clean safety and side-effect profile and creates an interesting opportunity for Invokana.

Invokana’s blockbuster potential
Will doctors prescribe Invokana over well-established therapies with new safety data in hand? I think it’s highly unlikely that we’ll witness a mass exodus from Januvia, but the timing of the pancreatitis analysis study does work in the new drug’s favor. Let’s just not forget that Invokana has cardiovascular concerns of its own to deal with. Still, the drug beat Januvia head-to-head when it came to lowering blood glucose levels in clinical trials and was also found to contribute to weight loss, a concern for diabetes patients. With or without displacing Januvia, Invokana has blockbuster potential and should be a great addition to Johnson & Johnson (NYSE:JNJ)’s product lineup.

The article Johnson & Johnson Invokana PDUFA Preview originally appeared on Fool.com.

Fool contributor Maxx Chatsko has no position in any stocks mentioned. Check out his personal portfolio, his CAPS page, or follow him on Twitter @BlacknGoldFool to keep up with his writing on energy, bioprocessing, and emerging technologies.The Motley Fool recommends and owns shares of Johnson & Johnson.

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