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AstraZeneca and BTG sepsis drug fails

pharmafile | August 8, 2012 | News story | Research and Development, Sales and Marketing AZD977, AstraZeneca, BTG, CytoFab, sepsis 

AstraZeneca’s pipeline has suffered another blow with the troubled company halting development of an investigational sepsis drug following poor Phase II results.

Only last month it reported an 18% drop in revenue for the second quarter, hit by major patent losses including its antipsychotic Seroquel, and with major sellers like Crestor wobbling.

The news that AZD9773 (CytoFab) did not show any significant improvement versus placebo for patients with severe sepsis and/or septic shock – conditions triggered by uncontrolled bacterial infection – simply adds to the gloom.

In the global double-blind Phase IIb study which began in 2009, two doses of the drug did not help with the primary endpoint – ventilator-free days – or with secondary endpoints which included mortality.

As a result, AstraZeneca is cutting its losses and handing the product back to UK-based BTG, which discovered it.

BTG will take a charge of around £28m as a consequence of the failure, and will have to hope its other areas of interest, such as antidotes to treat toxicity associated with medicines used for heart conditions and cancer, bear more fruit.

“These results are obviously disappointing, as the treatment of severe sepsis remains a major unmet need,” said BTG chief executive Louise Makin. “Our core business and trading continue on track.”

AZD9773 had been due to become part of the research in a Europe-wide public-private partnership into finding new antibiotics for all manner of bacterial infections, announced in May.

AstraZeneca has had its own well-publicised woes this year: former chief executive David Brennan left the firm in April, after investors expressed their concern over a string of late-stage pipeline failures and poor financial results.

The company forecasts a fall in full-year core earnings to between $5.85 and $6.15 a share, with revenue set to decline by a low- to mid-teen percentage rate this year in constant currencies.

Adam Hill

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