Roche/Ipsen's taspoglutide meets Ph III endpoints, beating Merck & Co's Januvia

Results from two further Phase III clinical trials show that Swiss pharmaceutical major Roche's diabetes drug candidate, once-weekly taspoglutide, met its primary end-points in head-to-head study with US drug giant Merck & Co's Januvia (sitagliptin) ' which generated global sales of some $1.4 billion in 2008 - and placebo.

The results of T-emerge 1 showed that, in patients with type 2 diabetes, taspoglutide demonstrated superior HbA1c reduction versus placebo. The study analysis included 373 patients, enrolled into three arms (taspoglutide 10mg once weekly, taspoglutide 10mg once weekly titrated up to 20mg once weekly after four weeks, and placebo).

T-emerge 4 showed that taspoglutide demonstrated superior HbA1c reduction versus sitagliptin. The study analysis included 636 patients, enrolled into four arms (taspoglutide at doses of 10mg and 20mg, sitagliptin 100mg and placebo) in a ratio of 2:2:2:1. In both studies taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.

Further studies to be presented

In addition to the already released T-emerge 2 study, data from T-emerge 1 and T-emerge 4 will be submitted for presentation at upcoming international scientific meetings. In addition, five other phase III trials exploring taspoglutide in patients with diabetes are ongoing, said the Swiss firm. It will also present previously-released positive results from the T-EMERGE 2 trial, which compared taspoglutide head-to-head with Eli Lilly and Amylin's Byetta (exenatide).

Roche exercised its licensing option for taspoglutide from French drugmaker Ipsen in 2006 and acquired exclusive worldwide rights to develop and market the compound, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to co-market the product.

Pancreatic problems seen with Januvia and other drugs

Earlier this year, US Food and Drug Administration said it suspected Merck's Januvia may be linked to serious cases of inflamed pancreas, but company officials said they did not think that existing data established such a relationship. The FDA said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009. Because a number of patients developed the condition soon after taking Januvia, or Merck's related drug Janumet (sitagliptin/metformin), and more than half saw it disappear after they stopped using it, "FDA believes there may be an association" with the drug. Several other rival products, including Amylin's Byetta, have also been linked to an increased risk of pancreatitis, which can be deadly if not treated.

At the time of the FDA comments, Barbara Ryan, an analyst at Deutsche Bank, said the news is unlikely to affect sales of Januvia. Merck has forecast 2009 combined sales of between $2.4 billion and $2.7 billion for the two diabetes drugs. "It's more an issue related to diabetes. You're going to find that irrespective of what therapy people are on," she said, adding: "The question is whether the incidence is higher than what would be expected."