Novo Nordisk Takes On All Comers

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Last week, biopharma giant Novo Nordisk (NYSE: NVO) revealed more data for its next potential blockbuster diabetes treatment. In the process, it gave investors some data to look forward to.

In conjunction with its investors' day last week, Novo released data for its drug candidate liraglutide. The data showed that liraglutide was more effective in helping type 2 diabetic patients control their blood-sugar levels than long-genericized diabetes treatment Amaryl from Sanofi-Aventis (NYSE: SNY).

Liraglutide is what is known as a GLP-1 analogue. It will compete most directly with Amylin Pharmaceuticals (Nasdaq: AMLN) and Eli Lilly’s (NYSE: LLY) similar GLP-1 analogue Byetta, if it can make it through the FDA rigmarole. Other drugmakers, like GlaxoSmithKline (NYSE: GSK), also have GLP-1 analogues in development.

While this most recently announced liraglutide phase 3 trial was not the most critical study for the drug’s future, it is another successful notch showing that it works against some of the most commonly used diabetes treatments on the market. Based on the success of liraglutide in studies against compounds like Byetta and in combination with other commonly used diabetes treatments like metformin, Novo filed a marketing application with the FDA for liraglutide earlier this year.

Barring any potential FDA delays (which many drugmakers have been receiving lately), Novo Nordisk is set for a March 23 PDUFA date with the agency. Novo Nordisk investors will have plenty of liraglutide news to digest after that date, though, because Novo guided last week for a third-quarter 2009 release of another phase 3 trial comparing liraglutide to Merck’s (NYSE: MRK) blockbuster Januvia.

Since diabetes is such a crowded indication, with so many actual and potential drugs on the market to treat the disease, if liraglutide can significantly outperform Januvia when results are announced next year, Novo Nordisk will likely have a very profitable compound to add to its stable of diabetes medicines.

On the other hand, if liraglutide underperforms Januvia in helping patients to control their blood-sugar levels, Novo will have some hard obstacles to overcome in convincing doctors and patients to take liraglutide over Januvia -- especially considering that liraglutide is an injection while Januvia is a pill. Even with successful studies already on the books against several of the legacy diabetes treatments like Amaryl, a bad outcome versus Januvia is something that would stunt Novo’s liraglutide sales growth if it makes it to the market.