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Eli Lilly (LLY) has made it five out of five for positive pivotal data for its brightest pipeline hope, dulaglutide, setting the stage for an end of year filing for the GLP-1 agonist and the company's planned fightback against the dominance of Novo Nordisk (NVO) and Sanofi (SNY) in the diabetes space.

Yesterday Lilly reported results from the Award-2 and Award-4 trials, which put dulaglutide up against the long-acting insulin Lantus. In this test, the project again showed superiority when used as a monotherapy against Lantus, and when both it and Lantus were combined with Humalog. This rare feat for a GLP-1 agonist, repeating the results of previous trials where dulaglutide had shown superiority against Byetta, metformin and Januvia, could mean that despite its late entry to the market, dulaglutide could be a credible threat.

Safety First

Many had expected the data to be positive so there was little impact on Lilly’s share price. But by hitting all of its targets, confidence is growing that the project, which is forecast to achieve sales of $557m by 2018, could challenge not only Bydureon and Victoza, but potentially even the mighty Lantus.

Much of this will depend on what kind of safety profile dulaglutide can boast. Little fresh light was shed on this yesterday. Alongside details about the data, information on adverse events was also missing from Lilly’s release. The closest Lilly got in this direction was to mention gastrointestinal issues, for which GLP-1s as a class are already famed.

This lack of clarity on safety will almost certainly heighten interest in the detailed look at the data expected at the American Diabetes Association conference in June. Also of interest will be how Lantus was titrated during the trial, which could have had a significant impact on the superiority claims for dulaglutide. If it turns out that patients’ blood sugar levels in the Lantus group took a long time to reach the required levels, the drug might not be as efficacious as is being claimed.

Nipping At Heels

However, if dulaglutide can show a clean safety profile and that Lantus was properly tritrated, analysts at Bryan Garnier believe could it become a first-in-class once-weekly product and a real threat to Victoza, despite potentially being fifth to market. Last year, Victoza chalked up sales of $1.64bn.

Dulaglutide certainly has dosing advantages compared with the once-daily administration for the Novo drug. But Victoza is the one product that dulaglutide has yet to take on and beat in the superiority stakes.

Lilly is proposing a head-to-head trial, but Award-6 is not due to start until the end of this year at the earliest and will not form part of the U.S. filing for dulaglutide. So until the results of this trial appear, which might not be until the beginning of 2015, Victoza is unlikely to be toppled from its market-leading position.

Interestingly, Bryan Garnier analysts also argue that dulaglutide could make some inroads into the $6.38bn of sales Lantus is forecast to achieve by 2018. They believe that if dulaglutide does prove superior to Lantus, then it might extend the time diabetics have before they are forced to move to long-acting insulins.

A filing for dulaglutide is expected by the end of the year, and if the project is given the all clear – which will depend on its safety profile – it will not only cement Lilly’s drive to have approved versions of all the newer diabetes drug classes, but could reshape the market.

Trial Comparator Status Trial ID
Award-1 Byetta Completed NCT01064687
Award-2 Lantus Completed NCT01075282
Award-3 metformin Completed NCT01126580
Award-4 Lantus with Humalog Completed NCT01191268
Award-5 Januvia Completed NCT00734474
Award-6 Victoza Planned NCT01624259
Source: Clean Superiority Sweep For Dulaglutide Could Reshape Diabetes Market