AstraZeneca (AZN) on Monday said that its experimental oncology drug Recentin failed a late-stage, head-to-head trial with Roche's (RHHBY) Avastin as a treatment for colon cancer. The issue for AstraZeneca's drug is less severe than some trial failures -- Recentin simply failed to prove non-inferiority in progression-free survival compared to Avastin.
To put it simply: There was "no statistically significant difference" between the results for Recentin and Avastin. AstraZeneca's drug wasn't better, but it wasn't appreciably worse either.
"While we recognized that challenging Avastin would be a high hurdle, it is still disappointing," says Alan Barge, head of oncology at AstraZeneca. Both therapies are designed to starve tumors by stopping them from building blood vessels.
High hopes surrounded the drug: Recentin is a pill that could replace the injected medication Avastin. But AstraZeneca said it will wait to see the results of a second late-stage trial before it makes a decision regarding a marketing plan and whether to file for regulatory approval of the drug. Investors knocked AstraZeneca down in late-day trading to $44.70, down 1.76%.
At Stake: Up to $329 Million By 2013
The other study is testing Recentin combined with chemotherapy against chemotherapy alone, and data are expected in the coming months. The study would provide more information on whether Recentin can benefit colorectal cancer patients and will help inform decisions about the program's future. But clearly, the drug already faces rough sailing ahead. Two years ago, AstraZeneca didn't continue to Phase 3 in lung cancer due to elevated safety concerns compared to lung cancer patients receiving chemotherapy alone.
AstraZeneca is no different than most pharmaceutical companies, trying to stave off revenue fall-offs by improving its drug pipeline. Analysts expected Recentin to reach sales of around $329 million by 2013, according to Thomson Pharma consensus forecasts.
Still, AstraZeneca reaffirmed its financial guidance for 2010 and its planning assumptions through to 2014, suggesting it doesn't expect a material impact on earnings over that period. But it's clear that investors see more risk to the company's earnings.
AstraZeneca also said results of a separate late-stage trial with Recentin in treating recurrent glioblastoma brain tumors are also expected in the first half of 2010. Initial data were encouraging.