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Arena and Eisai Announce Results of Re-Adjudication of Rat Mammary Tumors from Lorcaserin Carcinogenicity Study
Date:8/9/2011

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 9, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today results from a Pathology Working Group's (PWG) re-adjudication of female rat mammary tumor diagnoses from a two-year rat carcinogenicity study of lorcaserin. Arena convened the PWG in response to the lorcaserin Complete Response Letter (CRL), which questioned the certainty of the female rat mammary tumor classifications. The PWG reviewed relevant tissues and reported that mammary fibroadenomas (benign tumors) were distinguishable from mammary adenocarcinomas (malignant tumors). The PWG reported shifts in the numbers of both tumor types from the initial report included in the lorcaserin New Drug Application (NDA) and that adenocarcinomas were no longer numerically higher than the control group in the lorcaserin low- and mid-dose groups.

"We believe the PWG's report should further clarify the female rat mammary tumor diagnoses which, in combination with other data, may be helpful in assessing human risk," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer.

The PWG's re-adjudication is one of the activities intended to address the observation of mammary tumors in female rats and is part of the overall plan to submit a response to the lorcaserin CRL. Additional activities intended to address the CRL are ongoing.

Findings from Initial and PWG Reports The PWG consisted of five pathologists contracted by Arena. Arena consulted the US Food and Drug Administration (FDA) in selecting these pathologists. According to the PWG's re-adjudication, the incidence of adenocarcinomas was numerically lower than the control group in both the lorcaserin low (10 mg/kg/day) and mid (30 mg/kg/day) dose groups and was statistically higher than the control group in the lorcaserin high
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SOURCE Arena Pharmaceuticals, Inc.
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