(Corrects title in paragraph 5 to chief science officer, not chief financial officer)
COPENHAGEN, June 22 (Reuters) - Novo Nordisk NOVOb.CO will re-launch late-stage trials of its new diabetes drug liraglutide for treating obesity, the company said on Tuesday in a vote of confidence in the drug that has overcome safety concerns.
The Danish world no. 1 insulin producer said in a statement it would re-initiate the obesity programme, halted last year, in the first half of 2011 and the trials would comprise around 5,000 patients.
Liraglutide is sold under the name Victoza for treatment of type-2 diabetes after approval in Europe last year, and a belated approval in the all-important U.S. market in February.
After initiating one phase III study with Victoza for the treatment of obesity, Novo last year chose not to launch the remaining trials under the programme pending a decision on Victoza for the treatment of diabetes by the U.S. Food and Drug Administration, which had safety concerns.
“We wanted clarity on the type-2 diabetes indication before we continued to develop the drug for obesity. Now we have an approval, a nice label, and the product is doing very well in the market,” Chief Science Officer Mads Krogsgaard Thomsen told Reuters.
Novo, which had initially planned to launch the remaining phase III obesity studies in 2009 and 2010, now expects to finish the studies in 2013, Krogsgaard said.
“This is not going to be a general slimming agent, but rather one that is fulfilling a true medical need in the field of medical obesity -- where people are either very obese, or are obese and have pre-diabetes or other metabolic disturbances,” Krogsgaard said.
Novo Nordisk said the re-launch underlined its aim to develop its liraglutide portfolio, which also includes a cardiovascular trial of Victoza, a combination of Victoza and new-generation experimental insulin degludec, and a once-weekly version of Victoza.
Victoza is a once-daily version of the new-generation GLP-1 type of drug which stimulates cells to release insulin when blood sugar levels are high.
“Novo Nordisk ... expects to outline the clinical development strategy for semaglutide, a once-weekly GLP-1 analogue, and the once-weekly version of liraglutide in the second half of 2011,” it said.
Semaglutide, which is based on a different molecule than Victoza, has finished phase II trials. The once-weekly version of Victoza is in the pre-clinical stage.
Victoza is seen as a likely blockbuster even though it may soon face tough competition. Eli Lilly LLY.N and Amylin Pharmaceuticals Inc AMLN.O expect U.S. approval this year for Bydureon, a once-weekly version of their Byetta. [ID:nLDE62E13Q]
Shares in Novo fell 1.6 percent by 1353 GMT while the STOXX 600 European healthcare index .SXDP was up 0.6 percent. (Reporting by Anna Ringstrom; Editing by Michael Shields)
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