Last updated: August 8, 2012 4:56 pm

BTG and AstraZeneca drug trial fails

Shares in BTG and AstraZeneca fell on Wednesday after trials of an experimental treatment for severe sepsis failed and the drug’s development was axed.

BTG said AstraZeneca had ceased its second stage trials of CytoFab – an experimental medicine owned by BTG but licensed to the Anglo-Swedish group – after the drug failed significantly to aid patients.

BTG, the specialist pharmaceuticals group, said results from CytoFab’s trials had not shown any significant reduction in the number of days that patients spent on ventilators compared with the placebo, nor cut the rate of mortality.

CytoFab was seen by analysts as a relatively high-risk gamble, but one that would have been lucrative for both the FTSE 250 drugmaker and AstraZeneca had it paid off.

Had it been approved for general market release, analysts estimated CytoFab’s potential annual sales at £1.2bn, with BTG entitled to about 20 per cent in royalties, and milestone payments during the drug’s development.

But the drug’s success was considered a long-shot, with James Gordon at JPMorgan Cazenove estimating its chance of success at 10 per cent.

Gary Waanders at Nomura Code, who on Wednesday cut his recommendation on BTG shares from “hold” to “sell”, said: “Today’s news is clearly disappointing, but as we highlighted in the past our concerns about the underlying risks associated with CytoFab in this high-risk area, we are not hugely surprised.”

Sepsis, which occurs when the body’s immune system overreacts to an infection and damages vital organs, affects some 3m people a year globally, with a mortality rate of roughly 30 per cent.

CytoFab’s failure has prompted BTG to take a £28m charge in the 2012 financial year, and marked a significant setback to both BTG and AstraZeneca’s development pipelines.

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

The drug’s failure is the latest in a string of problems for AstraZeneca, which last year took a $382m writedown against the failure of two late-stage medicines.

The second-largest pharmaceutical group in the UK by sales last month reported a 15 per cent fall in first-half revenues as the loss of exclusivity patents on some of its most lucrative drugs ran out.

AstraZeneca has a larger patent cliff than some of its rivals, with about half of its $33bn in annual revenue expected to disappear by 2016.

Shares in AstraZeneca fell 2.3 per cent to £30.12, while BTG shares fell as much as 10 per cent before recovering to trade 2 per cent down at 331.7p.

Eli Lilly, the US drugmaker, last year withdrew sepsis treatment Xigris from the market after trials showed that it failed to cut the mortality rate in patients with septic shock.

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