Game on continued- Januvia receives FDA approval

Game on continued- Januvia receives FDA approval

This morning Merck (NYSE:MRK) announced the Food and Drug Administration has granted approval for Januvia™ an oral medication for the treatment of type 2 diabetes. JANUVIA has been approved as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise is not enough. JANUVIA belongs to a new class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors that improves blood sugar control in patients with type 2 diabetes. JANUVIA enhances a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas.

In the next few weeks another DPP-4 from Novartis (NYSE:NVS) called Galvus should also gain FDA approval. This will set the stage for what will be an all out marketing assault by two of the biggest pharmaceutical companies in the world. As we mentioned yesterday Diabetic Investor’s next issue will examine this battle in depth as Januvia and Galvus entry into the market will have a wide ranging impact on the entire type 2 market.

Earlier handicappers believe Merck desperate to put the Vioxx debacle behind them needs Januvia to reach blockbuster status and will do whatever it takes to make Januvia a hit. However, Novartis already has experience in the type 2 market with Starlix, which could give them an edge when dealing with physicians. Even before today’s announcement both companies have been aggressively pre-selling their respective drugs. This is setting up as a fierce battle between two heavyweights, think Ali –Frazier in their prime.

But Merck and Novartis aren’t the only heavyweights looking to claim the title. Watching this fight are GlaxcoSmithKline (NYSE:GSK), Eli Lilly (NYSE:LLY), Pfizer (NYSE:PFE) and Amylin (NASDAQ:AMLN) all have products that either compete or compliment Januvia and Galvus. Type 2 diabetes is the most prevalent form of diabetes, according to American Diabetes Association (ADA) there are nearly 20 million patients with type 2 diabetes and another 54 million with pre-diabetes. Some analysts believe the market for type 2 medications could exceed $10 billion by the end of the decade.

With all the heavyweights involved this is shaping up as a battle royal – stay tuned.

David Kliff
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