Roche stock falls on anaemia drug delay
(Updates shares, adds analyst comment, wraps in Avastin)
By Sam Cage
ZURICH, Feb 26 (Reuters) - Stock in Roche Holding AG (ROG.VX) fell on Monday after the Swiss drugmaker said it had suspended enrolment in a trial of its experimental anaemia drug Cera due to safety concerns.
Roche said late on Friday it had suspended enrolment in a mid-stage trial of the drug, which has the brand name Mircera, in anaemic lung cancer patients because of an "imbalance" of deaths across the four arms of the study, a setback analysts said could delay its U.S. approval.
The news deepens growing safety concerns over a class of blockbuster drugs that also includes Amgen Inc.'s (AMGN.O) Aranesp and Epogen, and Johnson & Johnson's (JNJ.N) Procrit and Eprex.
"This news could be slightly negative for Roche certificates in the short term," Zuercher Kantonalbank analysts said in a note. "It could delay the development of Mircera in this indication."
Participation certificates in Roche, its most widely traded form of equity, were 0.6 percent lower at 223.10 Swiss francs by 0846 GMT.
Amgen, the world's biggest biotechnology company, has been seeking to block Cera from entering the U.S. market and competing with its largest products. Aranesp alone generates annual sales of about $4 billion. Cera, like its rivals, is a form of the natural protein erythropoietin, or EPO, which spurs the body to produce more red blood cells.
Some doctors have speculated EPO may feed tumours and help them grow, a possible explanation for higher death rates among EPO users in some recent cancer trials.
Roche has asked U.S. regulators to approve Cera to treat anaemia in patients with kidney disease. It may later seek approval to market the drug for cancer patients that are anaemic.
JAPAN BOOST
Separately, Roche also said its Avastin drug had been recommended for use in Japan in patients with advanced or recurrent colorectal cancer. Approval is expected by mid-year, Roche said early on Monday.
Avastin, tipped by some analysts as a potential $8 billion seller, is one of a new family of drugs that work by starving tumours of their blood supply.
It has already been approved for use in colorectal cancer and non-small cell lung cancer in the United States and Europe.
The drug is marketed by Roche's partners Chugai Pharmaceutical Co. Ltd. (4519.T) in Japan and Genentech Inc. DNA.N in the United States.
((Reporting by Sam Cage,
Editing by Quentin Bryar;
Email: zurich.newsroom@reuters.com
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