Recently, results from Novo Nordisk’s (NVO) LEAD 6 extension study was published in Diabetes Care. The study aimed at evaluating the efficacy and safety of switching from Amylin Pharmaceuticals (AMLN) and Eli Lilly’s (LLY) Byetta (exenatide) to Novo Nordisk’s Victoza. 

The LEAD 6 study was conducted over 26 weeks on 389 patients, which compared the effectiveness and safety of once a day Victoza (1.8 milligrams plus oral anti diabetes drug (OAD)) to twice daily Byetta (10 micrograms plus OAD). It was observed that patients taking Victoza showed better results in lowering blood sugar and fasting glucose level compared to Byetta.
 
In Jan 2010, Victoza received approval from the US Food and Drug Administration (FDA) for the treatment of type II diabetes in adults. The drug is approved for use with proper diet, exercise and other diabetes medicines for lowering blood sugar levels. However, the FDA has not recommended Victoza as an initial therapy in patients who could not control diabetes with diet and exercise alone.
 
Victoza’s sales potential is limited since it has not been approved as first-line treatment. However, there is a huge unmet demand in the diabetes market where more than 1.5 million new cases are diagnosed annually. 

Victoza and Byetta are the only glucagon-like peptide-1 (GLP-1) molecules currently available. Victoza is likely to witness increased competition as a once-weekly formulation of Byetta (proposed trade name: Bydureon) could receive approval later this year for the treatment of type II diabetes. 

Other GLP-1 molecules under development include GlaxoSmithKline’s (GSK) Syncria (albiglutide) and Roche/Ipsen’s taspoglutide. We note that Glaxo’s Syncria, currently in a phase III program, is also a once-weekly injection.
Read the full analyst report on “NVO”
Read the full analyst report on “AMLN”
Read the full analyst report on “LLY”
Read the full analyst report on “GSK”
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