Roche has delayed development of its potential blockbuster type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects, including skin reactions and digestive symptoms. Heart and respiratory events were also observed in some patients. Roche will use the additional time to identify patients who are sensitive to the treatment and remove them from clinical trials. The Swiss drugmaker, which is developing the once-weekly injection in conjunction with French company Ipsen, had originally planned on filing for approval in 2011. A Jefferies industry analyst told Reuters that an approval may not come until 2014.
"A delay of 12 to 18 months is not good," Andrew Weiss, an analyst at Bank Vontobel, told BusinessWeek. "It's an important drug for Roche and they need it on the market to balance out the oncology franchise, which is starting to slow down." Cancer blockbusters Rituxan, Herceptin and Avastin make up 50 percent of the drugmaker's sales.
When positive results from a large Phase III trial were revealed earlier this year, analysts projected the drug could reach $2.8 billion a year in sales. But tolerability problems unveiled at a recent diabetes conference, in conjunction with this delay, have cause industry experts to adjust taspoglutide's market potential to just $490 million in 2014. If approved taspoglutide will compete with Novo Nordisk's Victoza, which is already on the market, and Amylin's Bydureon.