Lilly's dulaglutide hits the mark for comparability to Victoza in a blockbuster showdown

Enrique Conterno, president of Lilly Diabetes

Eli Lilly says its closely watched GLP-1 diabetes drug dulaglutide works as well as the market leading therapy Victoza, but isn't superior to the rival drug. That's going to be good enough for Lilly ($LLY) to claim a big win, though, as analysts were ready to hand it a victory on non-inferiority for a once-weekly drug now in the hands of regulators.

Lilly handed out the results in advance to a pair of experienced drug reporters at The Wall Street Journal and Reuters. Sherry Martin, a Lilly senior medical director, told the Journal's Peter Loftus that while the results for dulaglutide in AWARD-6 did not demonstrate superiority, measuring changes in HbA1c over 26 weeks, this was the first time another GLP-1 drug was shown to be non-inferior to the blockbuster competition.

There wasn't much actual data to pick through early Tuesday. Lilly--which is desperate to win some significant approvals--has a tremendous amount at stake on dulaglutide, perhaps its most important new diabetes drug in a portfolio of new drugs. But in addition to an approval, Lilly also must carve out a significant market share in diabetes, a hotly contested disease with major league competition. And that's where the AWARD-6 head-to-head trial will figure in. Lilly has gone 5 years without any major approval, a dry spell that has coincided with the loss of patent protection on key products.

Peak sales projections for dulaglutide are all over the map. Cowen has pegged the potential at $700 million, with Bernstein's Tim Anderson projecting $1.7 billion in 2020. That's not enough to make up for the patent losses, but it would go a long way to providing some credibility for an R&D group that is drawing an increasing level of critical scrutiny. And today's results for Lilly could well boost its projected numbers.

Another dulaglutide bull, ISI's Mark Schoenebaum, notes that Lilly's easier treatment regimen--once weekly versus Victoza's once daily--should woo enough patients to get the drug to about $2 billion in annual sales. Lilly's shares were up only slightly this morning. The pharma giant has already posted data on the superiority of its drug compared to Byetta, Januvia and metformin.

"Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide's highest-approved dose in a Phase III trial," said Enrique Conterno, president of Lilly Diabetes, in a statement. "The AWARD-6 data, along with the previous five AWARD studies, give us confidence that dulaglutide can be an important treatment option for people with Type 2 diabetes. If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use."

Over the past two years Lilly has experienced a series of bitter setbacks in the clinic. But the company has had a good run in recent days, scoring a second round of positive data for its cancer drug ramucirumab and now success in AWARD-6. The clinical advances mark a major step forward in Lilly's quest to gain several new drug approvals per year in coming years, though a promised pair of approvals in 2013 never materialized.

- here's the press release
- read the report from The Wall Street Journal (sub. req.)

Special Report: 10 top drugs in biopharma's late-stage pipeline - Dulaglutide

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