Roche diabetes drug faces at least 12-month delay

A promising new diabetes drug being developed by Roche, under license from France's Ipsen, faces a delay of at least 12 to 18 months after hypersensitivity problems were seen in some patients. The higher rate of reactions in patients taking the drug triggered a change in clinical trial protocols, causing the delay to the development programme and raising questions about the medicine's commercial potential. Industry analysts at Jefferies said the market might now fully discount the drug because of worries about its future.

Swiss-based Roche said on Friday it was implementing a risk mitigation plan in the taspoglutide Phase III programme following cases of hypersensitivity reactions to the medicine, which is an injected product belonging to the GLP-1 class. "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," Roche said in a statement. It had been aiming to file taspoglutide worldwide in 2011. Roche shares fell 2.3 per cent by 0725 GMT on the news, while Ipsen – a much smaller company whose fortunes are tied closely to the experimental compound – tumbled 16 per cent. The most common symptoms in patients with hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.