Novo claims liraglutide as effective for diabetes as Byetta

NEW YORK Novo Nordisk boasted on Thursday that its experimental type 2 diabetes treatment would be as effective as its anticipated rival.

The Danish drugmaker is considering marketing its drug, liraglutide, in the U.S. one year earlier than reported. It may trump the long-acting version of Eli Lilly’s Byetta, Novo’s finance chief, Jesper Brandgaard, said at the Reuters Health Summit in New York.

Brandgaard added that the supplementary sales muscle would also expand Novo’s ability to promote the drug to general practitioners. “We believe that the efficacy that you will see with Byetta LAR and from liraglutide are likely to be similar,” Brandgaard said.

While once-a-week Byetta LAR is less tedious than liraglutide’s daily injections at a scheduled time, Brandgaard said it might not be the competitive edge it appears—the super fine needles Novo’s liraglutide uses are less difficult to administer and the overall process is shorter, he said.

“The injection process is more cumbersome in that you have a powder and a solvent, and you first have to mix it to dissolve the powder and get it up into a syringe, and then inject yourself. Whereas with liraglutide, you have a pen, you dial a dose, you inject yourself, it’s done,” Brandgaard said.

The drug is preloaded into a small ballpoint-like pen device that delivers measured doses.

Liraglutide is an engineered version of the human GLP-1 molecule that stimulates release of insulin only when glucose levels become too high.

“We think the GLP-1 is a market that can move the injectables from previously really being late-stage type 2 treatment to become earlier to mid-stage type 2 treatment,” Brandgaard said.

Novo plans to file for an approval review for liraglutide in the United States and Europe toward the end of the second quarter of 2008 and will seek approval in Japan before 2009, while Byetta LAR will be reportedly filed toward the end of the first half of 2009.

Brandgaard pointed out that Novo’s competition in the market will be limited, since insulin products developed by Pfizer and GlaxoSmithKline have faced significant obstacles.

This year, Novo increased its U.S. sales force from 1,200 to 1,900. The world’s largest diabetes care company said it could raise that by another 200 to 800 once liraglutide is added to its product arsenal. “There’s no easy way around having a competitive sales force,” he said.

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