By Peter Loftus
Arena Pharmaceuticals /zigman2/quotes/200715023/composite ARNA +1.28% Inc. and Eisai /zigman2/quotes/203064480/delayed JP:4523 +13.74% Inc. said Wednesday they expect to resubmit their application for U.S. regulatory approval of proposed diet drug lorcaserin by the end of 2011, following additional testing.
The Food and Drug Administration had rejected lorcaserin in October amid questions about its effectiveness, as well as the drug's association with breast-tumor growth in female rat studies.
Arena executives said Wednesday they met with agency officials "a few days ago" for an "end-of-review" meeting and discussed what additional information the agency needed to reconsider.
Based on the talks, Arena expects to resubmit an application for lorcaserin by the end of 2011, and may be able to shorten the timeline, the company said.
"We are encouraged by the outcome of the end-of-review meeting," Arena Chief Executive Jack Lief said on a conference call with analysts. "We have additional clarity on next steps as we seek to obtain the FDA's approval of lorcaserin. We're confident we have a path forward."
San Diego-based Arena said it would conduct additional experiments and studies to address the data linking lorcaserin to rat tumors. The company will attempt to demonstrate the mechanism by which lorcaserin causes such tumors, and to show that it's "reasonably irrelevant" to human risk.
Also, as part of a safety assessment, Arena will conduct a small clinical study of about 10 volunteers to measure concentrations of the drug in blood and cerebrospinal fluid.
Arena's share price and trading volume spiked on Monday on the Nasdaq Stock Market, rising 44% to $2.38 in 4 p.m. trading. In early trading Wednesday, shares were trading at $1.88.
CEO Mr. Lief was asked about the timing of the FDA meeting and the trading spike on the conference call. After saying Arena met with the FDA a few days ago, Lief said "our stock is typically volatile. I have no idea why our stock traded as many shares as it did."
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