Pharma's Big Drug Test

Breakthrough diabetes treatments may be on the horizon. What companies stand to win?

Several drug makers are doing battle in the growing diabetes drug market and Food and Drug Administration reviews in the coming months will likely make or break the players.

On April 1, an FDA advisory panel will review saxagliptin – a drug from Bristol-Myersand AstraZeneca. And on April 2nd we’ll hear more about liraglutide from Novo Nordisk.

Recommendations from these panels will likely determine whether the drugs gain marketing approval and should also give a hint of how well they will perform in the market.

There’s also new information coming out about the popular drug Byetta -- Amylin along with partners Eli Lillyand Alkermes plan to ask for approval of the extended-release version during the second quarter.

"The company put out a press release this morning that the once a week version of Byetta works better than Merck’s Januvia,” explains CNBC’s Mike Huckman.

All these applications will come amid tougher safety review standards for new diabetes drugs, with the FDA now more focused on heart risks. The agency wants companies developing diabetes drugs to include safety data for patients at higher risk of heart attacks or strokes.

The increased scrutiny follows related concerns about GlaxoSmithKline's diabetes drug Avandia two years ago, after a medical journal suggested the drug could increase the risk of heart attacks and heart-related deaths.

The Match-Ups

If approved, Novo's once-daily injection liraglutide is expected to be a heavy competitor with Amylin's current twice-daily injection Byetta and the extended LAR version, which is injected once weekly.

Both Byetta and liraglutide are part of the GLP-1 class, which controls blood sugar.

Meanwhile, Bristol-Myers' DPP-4 inhibitor saxagliptin would compete directly against Merck blockbuster Januvia.

Though the drug pairings use different methods to control blood-sugar levels, they all have the same goal, which will make for a crowded field of competitors.




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