Eli Lilly and Co. (LLY) announced that its Enzastaurin Phase III Study did not meet its primary endpoint in diffuse large B-cell lymphoma. The enzastaurin's PRELUDE study explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma or DLBCL.
According to the company, the study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies.
Lilly said it will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30 million. But, the company said that its previously-issued financial guidance for 2013 remains unchanged.
The company said in April that it reiterated its earnings per share view of $4.10 to $4.25 on a reported basis, or $3.82 to $3.97 on a non-GAAP basis. It still anticipates annual revenue between $22.6 billion and $23.4 billion for fiscal 2013.
Analysts polled by Thomson Reuters expect the company to report earnings of $3.91 per share on revenues of $22.82 billion for fiscal 2013. Analysts' estimates typically exclude special items.
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