Bydureon fails head-to-head trial with Novo's Victoza

Tools

Eli Lilly ($LLY), Amylin ($AMLN) and Alkermes ($ALKS) have a fresh Bydureon headache on their hands this morning. In a head-to-head study with Victoza, it was Novo Nordisk's new daily GLP-1 diabetes treatment that proved superior to the once-weekly experimental therapy in lowering blood sugar. Patients taking Bydureon, which has been pushed back twice by the FDA, experienced an average reduction in A1C levels of 1.3 percent, compared to a 1.5 percent drop for Victoza, thereby failing the primary endpoint of non-inferiority.

Investors swiftly responded to the fresh batch of troublesome Bydureon results. Amylin shares plunged 26 percent, Alkermes stock dropped 16 percent and Lilly shares declined by 28 cents. Nevertheless, the investigators chose to focus on the upside, noting the data still shows that Bydureon does what it is supposed to do.

"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 2 diabetes," said Gwen Krivi, vice president, product development, Lilly Diabetes. "This is the sixth DURATION study showing once-weekly Bydureon had a significant A1C reduction from baseline. If approved, Bydureon could provide millions of patients a once-weekly treatment option."

Novo Nordisk is likely to be cheered by the news. Victoza has been rapidly gobbling up market share in the GLP-1 drug market. Lilly, Amylin and Alkermes (which has a more limited stake tied to the delivery technology), meanwhile, are working together to respond to the FDA's CRL on Bydureon by the second half of this year.

The trouble with this data, note several analysts this morning, is that marketers would have a tougher time making a case for Bydureon, which is intended to be the much more convenient, next-gen successor to the twice-daily Byetta, the first GLP-1 drug and a blockbuster performer on the market. BMO Capital Markets analyst Robert Hazlett noted that the data "muddy Bydureon's commercial appeal."

- here's the joint release

Related Articles:
Novo benefits from the Bydureon setback
Bydureon - FDA's Top 10 Blockuster Decisions
Amylin shares crater after FDA rejects Bydureon app