In a setback to Eli Lilly, a late-stage study found that a closely watched experimental drug failed to meet its primary endpoint in combating breast cancer. Although expectations on Wall Street had already been low, the compound, called ramucirumab, did not demonstrate progression free survival and also missed a secondary endpoint – overall survival.
The drug, however, did yield a statistically significant benefit for the same endpoints in treating gastric cancer in a separate Phase III trial. Only top-line results from the studies were released (here is the Lilly statement). Nonetheless, the breast cancer findings hinder hopes that Lilly executives held to market the drug for a wide range of tumors which, of course, would provide the largest possible commercial opportunity.
Wall Street “expectations were low for (the drug in treating breast cancer), but they were not quite this low,” writes ISI Group analyst Mark Schoenebaum in note to investors. He recently forecast that sales for a breast cancer indication could reach $600 million in peak annual sales, but only if the clinical trial data was “great.”
The potential for recognize revenue to fight metastatic breast cancer was “significant when benchmarking” against Avastin, a drug sold by Roche, Sanford Bernstein analyst Tim Anderson wrote in an investor note this week. He pointed out that, in 2010, Avastin generated about $1 billion in sales in the US for that indication, although the following year, the FDA revoked approval for that indication after deciding the drug was not safe and effective for that use (back story).
Based on the outcome, Lilly (LLY) does not plan to seek FDA approval an indication to use the drug as a first-line treatment for breast cancer. The drugmaker plans to release complete data from the gastric cancer trial at an upcoming scientific conference, probably during the first half of next year. Meanwhile, Lilly continues to study the compound for treating other cancers, such as lung and colorectal.
Lilly is betting on winning approvals to treat various cancers to help compensate for various big-selling medicines that will lose patent protection. But the rdugmaker has suffered setbacks in other areas were large bets have been placed, notably Alzheimer's (read more here).
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