Novo Nordisk, fresh from being boosted by the news that a potential rival to its diabetes drug Victoza faces a delay, says it is re-starting late-stage trials of the compound as a potential treatment for obesity.

The Danish drugmaker will re-initiate the global Phase III development programme of Victoza (liraglutide) for the treatment of obesity, having been in dialogue with the US Food and Drug Administration since gaining approval for the compound as a treatment for type 2 diabetes across the Atlantic at the beginning of the year. Based on feedback from the FDA, Novo now plans to begin the programme in the first half of 2011 in trials comprising 5,000 patients.

After initiating a Phase III study with Victoza for weight loss, Novo decided last year not to launch other trials because “we wanted clarity on the type-2 diabetes indication before we continued to develop the drug for obesity,” chief financial officer Mads Krogsgaard Thomsen told Reuters. “Now we have an approval, a nice label and the product is doing very well in the market” for the once-daily drug, he added.

At the end of last year, Novo published data from a mid-stage trial which showed that liraglutide, an injectable human glucagon-like peptide-1 (GLP-1) analogue is more effective than Roche's Xenical (orlistat) in terms of weight loss and reducing blood pressure. The obesity market is a potentially lucrative one, but diabetes is still Novo’s main focus and the company said it is continuing to concentrate on the cardiovascular outcomes trial for Victoza (called LEADER), a fixed combination of the new-generation insulin degludec and liraglutide, and a once-weekly version of Victoza.

The Bagsvaerd, Copenhagen-headquartered firm added that it expects to “outline the clinical development strategy” for semaglutide, a once-weekly GLP-1 analogue, and the once-weekly version of Victoza in the second half of 2011.

12-18 month delay for Roche/Ipsen’s taspoglutide
News of the obesity trial came just after Roche and Ipsen said their rival experimental once-weekly GLP-1 analogue taspoglutide faces a significant delay after hypersensitivity problems led to a change to a change in clinical trial protocols.

The Swiss giant said it is implementing a risk mitigation plan in the taspoglutide Phase III programme after noting that the incidence of hypersensitivity reactions is higher than expected for the study population, “although it remains uncommon”. Roche added that “the impact of this plan on the project and in particular on the timelines for regulatory filing are currently being assessed, however, a minimum of 12 to 18 months delay is anticipated”. The company had hoped to file taspoglutide worldwide next year.