VIVUS, Inc. (VVUS) Sees CHMP Feedback on Qsiva Resubmission as 'Generally Positive'

As previously reported, VIVUS, Inc. (Nasdaq: VVUS), or the Company, had submitted to the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial, or AQCLAIM/OB-401, to support the resubmission of the marketing authorization application, or MAA, for approval in Europe of Qsiva for obesity under the centralized procedure. On December 20, 2013, CHMP provided feedback to the Company regarding AQCLAIM/OB-401. The Company views the CHMP feedback as generally positive and continues to review the feedback with its US- and EU-based Clinical and Regulatory advisors to gain alignment regarding the pathway forward for AQCLAIM/OB-401 and for the resubmission of the MAA.

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