March 8, 2010 / 10:27 AM / in 8 years

AstraZeneca's Recentin fails trial, hurts shares

LONDON (Reuters) - AstraZeneca’s cancer drug Recentin failed in a head to head late stage trial with Roche’s

Avastin in colorectal cancer patients, hurting the Anglo-Swedish drugmaker’s shares on Monday.

The company said the data, which analysts had expected to be negative for Recentin, showed the experimental drug did not meet its primary endpoint in the Horizon phase III study.

But it said it would wait for fresh data from a second late stage trial before making any decisions on filing the drug for approval.

AstraZeneca shares lost more than 1.7 percent to trade around 29.42 at 1006 GMT. Roche shares were down 0.5 percent.

“While we recognized that challenging Avastin would be a high hurdle, it is still disappointing, despite evidence of clinical activity with Recentin, not to have met the primary endpoint in this study,” Astra’s head of oncology Alan Barge said in a statement.

Recentin, a pill, was developed to challenge Roche’s injectable treatment Avastin. Both are targeted therapies designed to starve tumors by stopping them from building blood vessels, a process called anti-angiogenesis.

Analysts see Recentin reaching sales of around $329 million by 2013, according to Thomson Pharma consensus forecasts.

Morgan Stanley analysts said they saw a around a 2 percent downside risk to consensus forecasts for Astra’s earnings per share in 2014.

They said an upcoming U.S. ruling on a patent challenge to Astra’s cholesterol-lowering drug Crestor -- the firm’s most crucial sales driver -- was “the next critical catalyst” for the stock, and were “cautiously optimistic” on that.

A verdict on Crestor trial is expected from Delaware district court before the end of July, when the judge in the case is due to retire.

Panmure Gordon analysts said they expected AstraZeneca’s stock to come under pressure but added in a note: “We advocate buying on weakness as the mid-term guidance story remains intact, because Recentin was a high risk development.”

MORE RECENTIN DATA TO COME

Astra, which reaffirmed its financial guidance for 2010, said Horizon III was the first of “two pivotal studies” of Recentin, known generically as cediranib, in colorectal cancer.

The other study, Horizon II, is testing Recentin combined with chemotherapy against chemotherapy alone, and data are expected in the coming months.

Barge said the results of this trial would offer “further information on whether Recentin may provide benefit for patients with colorectal cancer and will inform any decision about possible regulatory filings.”

Ambrian analysts Mike Ward and Paul Diggle said in a note that they expected “a positive outcome for Horizon II.”

In January, AstraZeneca forecast of revenues of $28 billion to $34 billion over 2010 to 2014, including $4 billion to $6 billion of revenues from new drugs, pipeline products and licensing deals..

Last month the first raised its earnings per share forecast for 2010 to a range of $5.90 to $6.30 after settling a tax dispute in Britain.

Results of a separate late stage trial with Recentin in treating recurrent glioblastoma brain tumors are also expected in the first half of this year. Initial data showed it helped stop the fluid build-up caused by glioblastoma and helped mice with the brain tumors live longer.

Editing by Hans Peters

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