Biotech Values

[DewDiligence]

Sepsis Drug From AZN to Undergo Additional Midstage Testing

[A delay in CytoFab helps GTCB, who is developing a drug for DIC/sepsis along with partner, Leo Pharma.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20061103:MTFH05418_2...

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Fri Nov 3, 2006 4:09am ET
By Mark Potter and Ben Hirschler

LONDON, Nov 3 (Reuters) - AstraZeneca Plc (AZN) has unveiled a delay in the development of an experimental drug for severe sepsis which it bought in just 11 months ago in a bid to bolster a depleted pipeline of new drugs.

The Anglo-Swedish drugmaker said on Friday it planned to conduct a further intermediate Phase II clinical trial for CytoFab, a treatment for sepsis it licensed from British biotechnology firm Protherics Plc (PTI.L) in a deal worth up to 195 million pounds ($372 million) last December.

The hope is that the new trial, lasting up to 21 months, could lead to quicker progress for the drug in final-stage trials. Industry analysts already view the project as risky, give the high failure rate of past sepsis drug candidates.

Shares in Protherics fell as much as 12 percent in early trade. AstraZeneca shares were little moved.

AstraZeneca, which has struck a string of deals aimed at bolstering a drugs pipeline hit by the failure of several of its own drugs, said the extra Phase II trial was likely to start in the second half of 2007.

AstraZeneca spokesman Steve Brown said the move could in theory delay the progress of CytoFab by 21 months. "But that 21 months might come down if we can shorten the timelines in Phase III, given what we do in the additional Phase II programme," he said.

AstraZeneca had originally hoped to start Phase III trials in 2007 and file the drug with regulators sometime after 2008.

ASTRAZENECA COMMITTED

Piper Jaffray analyst Sam Fazeli said a shorter Phase III trial could limit the delay to around 10-12 months.

Protherics Chief Executive Andrew Heath said AstraZeneca remained committed to CytoFab and that his company was guiding analysts not to change their forecasts for milestone payments due to be received by Protherics during 2007.

At 0855 GMT, Protherics shares were down 9.5 percent at 79 pence, off a low of 76-1/2 pence and valuing the business at about 204 million pounds. AstraZeneca was flat at 31.99 pounds.

"The company has recently completed consultations with regulators in the United States and EU," AstraZeneca said in a statement. "These consultations confirmed that a single Phase III study could be sufficient for regulatory approval. Furthermore, to meet the regulatory needs of both agencies, it is required that AstraZeneca implement a Phase II study programme to support the single global Phase III study," it said.

AstraZeneca said last month that experimental stroke drug NXY-059 had failed a key clinical trial, the latest in a series of blows to its drugs pipeline after earlier failures of cancer drug Iressa, anti-clot pill Exanta, and Galida for diabetes.

The rewards for a successful medicine to treat sepsis, or septic shock, which affects 3 million people a year worldwide, are likely to be substantial.

But the drug industry is littered with previous failures in the area, suggesting there is no guarantee that CytoFab will necessarily get to market. Eli Lilly and Co's (LLY) Xigris is currently the only licensed treatment for sepsis [and it is not a very good drug (#msg-12483101)].
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