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AstraZeneca and BGT shelve experimental sepsis drug

Decision follows CytoFab’s poor mid-stage clinical trial results

AstraZeneca has ended its collaboration with BTG to develop a drug to help patients with severe sepsis after it failed in mid-stage clinical trials.

CytoFab (AZD9772) did not show any significant improvements versus placebo in respect of the primary endpoint, ventilator-free day, or secondary endpoint including mortality.

As a result, AstraZeneca has decided to halt further development and handed the asset back to BTG.

“These results are obviously disappointing, as the treatment of severe sepsis remains a major unmet need,” said Louise Makin, CEO of BTG. 

The partnership began in 2009, after AstraZeneca successfully completed a Phase IIa study of AZD9772 (CytoFab), in 70 patients with severe sepsis. Phase IIb, which aimed to assess efficacy and safety, began in in 2010 with 300 patients and involved two doses of CytoFab plus placebo. 

Had the partnership produced a successful drug, annual sales could have generated £1bn per year, Deutsche Bank analyst Richard Parkes told Reuters, with BTG entitled to 25 per cent.

Sepsis is a potentially fatal illness caused when the body has a severe overreaction to an infection. The NHS estimates that there are over 30,000 cases of severe sepsis in the UK every year, with around 3 million world, and an approximate 30-50 per cent mortality rate. 

The decision will have more of a detrimental affect on BTG than AstraZeneca, with the former expected to take a charge of approximately £28m in the current financial year. But Makin said BTG's core business and trading will “continue on track”.

However, CytoFab's failure also casts further doubts on AstraZeneca's research capabilities, after a number of previous pipeline drugs failed to make it past the trial stages.

In March this year, the company pulled out of a research collaboration with Targacept to develop an antidepressant, while last year it decided to discontinue its cancer treatment olaparib.

9th August 2012

From: Research

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