Adults with type 2 diabetes can breath a sigh of relief after Novo-Nordisk's Victoza was approved by the Food and Drug Administration yesterday. Safety concerns initially delayed the approval of the drug for nearly 10 months. The biochemical technology company will see a vast increase in sales by 2015, but they're aren't the only ones waiting for approval on the same type of drug that will also generate similar revenues for competitive companies.
Byetta, a twice-daily shot from Indianapolis-based Eli Lilly & Co. and Amylin Pharmaceuticals Inc. of San Diego are battling for the same approval received for Victoza. The first approval is only a large stepping stone for Byetta, rather than a hinderance. The drugs have shown to produce different side effects in patients, which could be their ultimate deciding factor on which company ends up winning the profit race once others are approved.
Victoza research has shown it to cause pancreatitis, an inflammation of the pancreas. The shot injects a hormone called GLP-1 that stimulates the pancreas to produce more insulin after meals. Victoza also posed a risk for thyroid cancer and the requirement of a risk-mitigation strategy.
The FDA comments on this concern: "In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis."
These initial safety concerns kept Victoza on the back burner for approval for those 10 months, but the competitors might not find the same delay. The approval of the drug bodes well for their chance to get in on the profits as well as concentrate on any other side effects from the already approved diabetic drug treatment. A Citi investment research analyst commented about the rising shares of Amylin, from $14 to $27, which a Barclays analyst reaffirmed a raised priced target from $22 to $24.
The main competitor right now is Byetta (called exenatide LA) by Amylin and partner Eli Lilly & Co. "Victoza approval bodes well for exenatide (LAR's) prospects, both on approval and commercial prospects," stated Jefferies & Co. analyst Thomas Wei, in a note to investors.
Americans with diabetes tallies to a whopping 23.6 million people or 7.8% of the population, according to the National Diabetes Fact Sheet of the National Center for Chronic Disease Prevention and Heath Promotion. The diagnosed include 17.9 million people, while the undiagnosed totals 5.7 million people. This massive group of people will enjoy the new influx of diabetic drug treatment, but the companies gaining all of the financial benefits will be just as satisfied.
Written by Amy Munday
Huliq.com
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