Hapoaliom Views Arena's Lorcaserin As Unapprovable

Hapoalim Securities has published a research report on Arena Pharmaceuticals ARNA after the company completed its End of Review meeting with the FDA concerning Lorcaserin. In the report, Hapoalim Securities writes "Arena announced that it has completed the planned Type A (End of Review) meeting with the FDA to discuss the Complete Response Letter (CRL) and the path forward for lorcaserin as a treatment for obesity. Based on guidance from the agency, Arena plans to do additional pre-clinical studies to examine prolactin (to show a breast cancer mechanism), and brain levels of lorcaserin in rats as well as a 10 patient human trial to examine lorcaserin levels in the cerebrospinal fluid (CSF). Arena expects to receive the FDA meeting minutes in January, prior to finalizing the study protocols and expects to resubmit the lorcaserin NDA by the end of 2011. We continue to view lorcaserin as unapprovable even if it successfully completes the FDA recommended studies. The efficacy of lorcaserin is minimal and therefore we do not expect the FDA to view the potential safety risk of breast cancer and astrocytoma as acceptable considering the limited efficacy. The recently reported BLOOM DM study reinforces our view and brings up the additional safety issue of cardiac valvulopathy." Hapoalim maintains its Sell rating and $1 price target. Arena Pharmaceuticals closed yesterday at $1.80.