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Lilly, Amylin diabetes drug disappoints

Bydureon, a longer-acting version of Lilly and Amylin's Byetta, was not as effective as Novo Nordisk's Victoza in a newly released 900-patient study

Bydureon (exenatide extended-release for injectable suspension), an experimental drug that is a longer-acting version of Lilly and Amylin's Byetta, was not as effective as Novo Nordisk's Victoza (liraglutide) in a newly released 26-week, 900-patient study.

Bydureon, which is being developed by Lilly and Amylin in partnership with Alkermes, is a once-weekly injection that makes use of Alkermes' proprietary Medisorb technology for long-acting medications. Victoza, a daily injection, was approved in the US in January 2010. Both drugs, like Byetta, are GLP-1 receptor agonists that stimulate insulin production to regulate blood sugar in type 2 diabetes patients.

The topline results from the open-label Duration-6 study, which was conducted by Lilly and Amylin, found that patients on Bydureon had a reduction in A1C, a measurement of average blood sugar, of 1.3 percentage points from their baseline levels, compared with a 1.5 percentage-point reduction in those receiving Victoza. The pre-specified primary endpoint of the study had been Bydureon's non-inferiority to Victoza in this measure.

However, the study did show that gastrointestinal adverse events, including vomiting and diarrhoea, occurred less frequently in the Bydureon group than in the Victoza group. With Victoza, nausea was reported among 20 per cent of patients, vomiting in 11 per cent, and diarrhoea in 13 per cent. With Bydureon, nausea was reported in 9 per cent, vomiting in 4 per cent, and diarrhoea in 6 per cent.

The companies said they plan to submit the study for publication once a full evaluation of the data has been completed.

The disappointing study results are another setback on what has been a difficult road for Bydureon. In October, the US Food and Drug Administration (FDA) issued a complete response letter requesting that a new clinical study be added to the marketing application to evaluate the cardiovascular safety of levels of exenatide higher than typically used therapeutically. It was the second complete response letter that the FDA had issued for the application, which was submitted in May 2009.

The first complete response letter was issued in March, 2010, with requests for clarification on the drug's manufacturing process, finalisation of the product labelling and a risk management strategy.

4th March 2011

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