Novo’s Victoza beats Bydureon in head-to-head trial
pharmafile | March 4, 2011 | News story | Research and Development, Sales and Marketing | Alkermes, Amylin, Byureon, Victoza, diabetes, exenatide, lilly, type II diabetes
Bydureon has been outperformed by rival Victoza in a head-to-trial, decimating shares in its co-developer Amylin and Alkermes, the company that discovered the type II diabetes drug.
Bydureon failed to show non-inferiority to Novo Nordisk’s Victoza, the primary endpoint of the trial, causing shares in Amylin – whose future is heavily tied to the drug’s success – to fall by 25% yesterday.
Shares in Alkermes, which was set to receive substantial royalties from the drug, also took a dive, dropping by 12 per cent.
The drugs are both injectable GLP-1 treatments, with Bydureon a once-weekly jab to Victoza’s daily treatment regimen.
Bydureon’s lackluster performance is good news for Novo as it looks to gain market share for Victoza following US approval in January last year and a European green-light in mid-2009.
Gwen Krivi, VP of product development at Lilly Diabetes, remained upbeat: “While this study did not meet its primary endpoint, these results reinforce the important role of GLP-1 receptor agonists in the treatment of type II diabetes,” he said.
Krivi added that this was the sixth DURATION study to show Bydureon had a significant A1C reduction from baseline.
“If approved, Bydureon could provide millions of patients a once-weekly treatment option,” he said.
The 26-week, head-to-head, open-label, superiority study involved approximately 900 patients and further evaluation of its data set is underway. When complete the companies say they plan to submit the full study results for publication.
Bydureon is a once-weekly formulation of exenatide, the active ingredient in Lilly’s Byetta injection, which has been available in the US since 2005.
A New Drug Application for Bydureon was submitted to the FDA in 2009 but the US regulator knocked it back in March 2010, issuing a complete response letter and requesting further data.
The companies said they plan to submit a response in the second half of 2011 but this latest trial will prove a major blow.
Ben Adams
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