BioCentury
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Vivus falls on expected CHMP negative opinion

September 21, 2012 10:58 PM UTC

Vivus Inc. (NASDAQ:VVUS) fell $2.72 (11%) to $21 on Friday after the company said it expects EMA's CHMP to issue a negative opinion next month for an MAA for obesity drug Qsiva phentermine/topiramate. Vivus President Peter Tam told BioCentury that the committee had no product-specific issues with Qsiva. He said preliminary feedback indicated that the committee is concerned with the phentermine component of the fixed-dose combination of phentermine and topiramate. Tam said CHMP expressed "theoretical concerns" stemming from the lack of available long-term safety data for phentermine, as well as EMA's lack of experience with marketed phentermine. He said it is too early to say whether the company will need to conduct additional trials. Vivus expects CHMP's opinion around mid-October. The company said it will either resubmit the MAA or appeal the decision, depending on the nature of CHMP's objections. ...