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The law firm of Milberg LLP is investigating possible violations of the securities laws on behalf of those who have purchased the common stock of VIVUS, Inc. (“VIVUS” or the “Company”) (NASDAQ: VVUS).
VIVUS is a biopharmaceutical company based in California. The Company’s shares dropped $7 per share, or nearly 60%, on July 16, 2010, after a panel of outside advisers to the FDA recommended against approval of its Qnexa diet pill due to safety concerns. The safety concerns mentioned by the FDA include risks of depression, birth defects, and an increased heart rate. According to the panel, these risks combined to trump the efficacy of the drug.
CEO Leland Wilson brushed off these safety concerns during VIVUS’s most recent earnings conference call on May 3, 2010. Below is Wilson’s exchange with an analyst from brokerage firm Jeffries & Co.
1) Cardiovascular issues:
[Thomas Wei of Jeffries]: I just wanted to get your sense of or a reminder of, on a pooled basis, how many major cardiovascular adverse events did you have in those studies versus placebo? Do you know what the raw numbers are off the top of your head?
[Leland F. Wilson, CEO]: Yes. No, we have not – those are something that’s being adjudicated, and we do not have the final data on those at this point. We’re hopeful to have them by the advisory panel, but that’s something that’s outside of our hands right now because of an independent adjudication committee. We feel very strongly, as you know, that the cardiovascular benefits of this drug are really outstanding. And so we’re anxious to present our cardiovascular data. It is outstanding.
2) Depression and suicide:
[Thomas Wei of Jeffries]: [O]n psychiatric adverse events, I’m sure that you – the FDA has probably asked you for a similar meta-analysis like the one that was done for Acomplia. Can you share with us any findings from that analysis on how Qnexa looks versus placebo?
[Leland F. Wilson, CEO]: We have presented all the data that we have on our psychiatric AEs to this point. I mean, clearly, we have probably the most thorough and complete look at – of both depression and suicidality of any product that’s ever been through the FDA through the Phase 3 program….So we think we have a very thorough and very convincing review of the psychiatric adverse events and we’re really very confident that we’re in very good shape here…And so we have just done an A to Z look at this and really in my view there is really nothing here to report.
If you currently hold common stock of VIVUS and would like to learn more about our investigation, or have any questions regarding this matter, please fill out the form to the right or contact the following attorney:
Andrei Rado, Esq.
Milberg LLP
One Pennsylvania Plaza, 49th Fl.
New York, NY 10119-0165
Phone number: (800) 320-5081
Email: arado@milberg.com
Milberg LLP has been representing individual and institutional investors for more than four decades and serves as lead counsel in federal and state courts throughout the United States. Please visit the Milberg website for more information about the Firm.
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