Fostamatinib/Onglyza - AstraZeneca

The developer: AstraZeneca
The drugs: fostamatinib/Onglyza

The scoop: Killing a Phase III program, even one that a company clearly no longer believes in, is close to impossible. Once a Phase III study is fully enrolled, the compulsion to get to the end and see if you've been riding a rainbow is powerful. There's also an ethical responsibility to the patients who enrolled. And, after all, it just might work.

All of those considerations were on display at AstraZeneca ($AZN) when it doggedly continued to pursue a Phase III program for fostamatinib. At one point, the lack of enthusiasm was palpable. It was no surprise, then, to detect an air of relief in the air when it was finally time to call it a profound disappointment at the end of the Phase III program and hand the rheumatoid arthritis drug back to Rigel ($RIGL) in June, washing its hands of another late-stage partnership that had failed to deliver. Then came the Onglyza failure in a Phase III cardiovascular trial--eliminating a blockbuster opportunity for the diabetes drug--and the back-to-back setbacks began to raise some serious questions about AstraZeneca's slow-motion plan to right a badly listing ship.

It's not easy fixing a big research organization after it's derailed, and few had reached the straits that AstraZeneca found itself in when CEO David Brennan was finally shown the door. New CEO Pascal Soriot did what anyone would do in his position: declare a defeat and promise a new day in R&D. The back-to-back fostamatinib/Onglyza failures, though, reminded everyone just how far this company has to travel and question Soriot's timetable.

It fell on Soriot's shoulders to hold the fort against the renewed wave of criticism, pointing once again to long-term plans to build a new HQ/research complex in Cambridge, U.K. Late-stage deals this year were also aimed at satisfying the critics, though some wondered just how important AstraZeneca's new therapies will be if they are ushered into crowded fields.

The fostamatinib/Onglyza failures ended Soriot's honeymoon with some analysts early. Now the company needs to prove it knows how to develop top prospects. And that's a lot of pressure.

For more:
Another drug study flops at AstraZeneca as CEO braces for bumpy turnaround
AstraZeneca tosses another PhIII failure onto the scrap heap
AstraZeneca reports hit-and-miss PhIII for arthritis pill

Fostamatinib/Onglyza - AstraZeneca

Suggested Articles

With a new research team, outlook and more than a little help from the tech world, GSK has been quietly going about shoring up its pipeline.

The World Health Organization has called out Big Pharma for its dearth of antibiotic innovation amid a growing threat of antimicrobial resistance.

The trial hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.