Monday, February 13, 2006

Roche - Avastin: a sixty day safety pause

Poor Roche. They have had to call a 60 day halt to enrollment in a Phase III trial of its cancer drug Avastin (bevacizumab) on concerns over safety, causing its shares to drop up to 5% in early morning trading across Europe.

Recruitment in the AVANT study, which is assessing the drug's efficacy in preventing colon cancer recurrence following surgery, was stopped as it emerged that more deaths had occurred in patients taking a combination of Avastin and Xelox (Roche's Xeloda [capecitabine] plus Sanofi-Aventis' cancer drug Eloxatin [oxaliplatin]) compared to those receiving a regimen of Avastin and the standard chemotherapy combination Folfox (oxaliplatin, 5-fluorouracil, leucovorin), or Folfox alone.

Avastin, one of the fastest growing of Roche's top-five sellers, was the first drug to be approved in a new class of cancer agents that work by inhibiting the formation of blood vessels to the tumour. Referred to by many as "a pipeline in a product," due to its potential application across a spectrum of tumour types, Avastin, which is marketed in the USA by Genentech, pulled in sales of 1.7 billion Swiss francs ($1.3 billion) for Roche in 2005 - its first full year on the market.

Insiders' view: Worrying, hence the share price drop. Even if the study carries on it may mean that risk/benefit ratios will have tilted away from Avastin.

Source: Pharma Times

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