Onglyza fails outcomes trial in a $1B hit for Bristol-Myers, AstraZeneca

Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) have lost out on a $1 billion boost for their diabetes partnership. Onglyza failed to beat placebo in a key outcomes trial, dashing hopes that new data would turbo-charge sales.

The SAVOR trial aimed to show that Onglyza could stave off heart attacks, strokes and other cardiovascular complications in diabetes patients. Participants either had a history of heart disease or multiple risk factors. But though patients who added Onglyza to their standard therapy didn't fare any worse than placebo patients, outcomes-wise, they didn't fare better, either.

The companies released only top-line data from the study because it's up for presentation at the European Society of Cardiology meeting later this year. But it's clear that their bid for a superiority claim has fallen flat. Analysts had said that proving a cardiovascular benefit could have added up to $1 billion to Onglyza's peak sales, pushing the drug to $3 billion by 2020. It brought in $709 million last year.

Succeeding with their diabetes efforts is important to both companies. Not only do they need to grow sales to make up for big patent losses--Plavix in Bristol-Myers' case and Seroquel in AstraZeneca's--they recently staked an additional $7 billion on their partnership. Last year, they amped up with a two-step buyout of Amylin Pharmaceuticals and its diabetes fighters Byetta and Bydureon. Since then, they've literally pooled their diabetes marketing, combining their sales and marketing staffers in their own separate location.

But the SAVOR results are a particular disappointment to AstraZeneca, which has suffered a string of pipeline disappointments lately. New CEO Pascal Soriot is under pressure to turn things around, and he's pegged diabetes as one of the handful of growth drivers he's relying upon.

Onglyza has a history of disappointing the diabetes duo. Approved in 2009, the drug didn't storm onto the market. Sales have built slowly, but still fall short of early expectations. Meanwhile, the partnership's newest drug, Forxiga, recently won approval in Europe after a rejection from the FDA.

- read the release from AZ and BMS
- see the Reuters news
- get more from The Guardian

Special Report: AstraZeneca/Bristol-Myers Squibb - Top diabetes drug pipelines of 2012