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AVEO Pharmaceuticals, Inc. Message Board

  • weightbayou weightbayou May 4, 2013 11:37 PM Flag

    FDA rejected Vanda's drug then approved it months later

    This happened years ago. Th same thing could happen with Aveo. Fox Business thought Aveo would get their drug approved.
    Aveo’s stock has fallen from a high of around $20 to close to $7.50 as of April 26. The collapse in the stock price began when the FDA expressed ‘concern’ about the overall survival (OS) data. Aveo has since submitted additional OS data to the FDA.
    The concern was that in the TIVO-1 Phase 3 study, Sorafenib (Nexavar) posted an OS of 29.3 months versus Tivozanib’s 28.8 months. Close, but maybe no cigar. At first glance, it would appear Tivozanib underperformed the comparator, a second line therapy, already approved for RCC. A deeper dig strongly suggests something else is going on.
    Meanwhile, short sellers, sensing blood in the water, have shorted roughly 10% of the outstanding shares in a bet the ODAC will vote against approval. We believe shorts (who borrow and sell shares in hopes of buying them back later at a lower price) are worthy of respect, however, in this case we think they are wrong.
    The Tivo-1 study was designed so patients who were on Sorafenib could cross over to Tivozanib at disease progression. For the first 6 months, OS was comparable between the two arms, but then the OS trend line shows a slow separation occurring with Sorafenib outperforming, though not by a statistically significant amount.
    But at 6 months, 15% of patients in the Sorafenib arm had already switched to Tivozanib. At 18 months, 53% had switched, and by 26 months 67% were on Tivozanib. So was Sorafenib’s OS of 29.3 months mostly a result of the efficacy of Sorafenib or Tivozanib?
    If Tivozanib reached OS of 28.8 months with minimal crossover compared to the Sorafenib arm, we believe a strong case can be made that Tivozanib contributed the lion’s share of Sorafenib’s TIVO-1 OS result.
    In the TARGET study, Sorafenib was compared to placebo. The primary endpoint was overall survival. The final median OS for Sorafenib was 17.8 months.

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    • First, I lost a lot of money on Aveo and was shocked the vote was 13-1. Can anyone explain the lopsided decision? AT worst it was a close call. Second, because of that vote, the decision will not be overtuned IMO.

    • I own aveo so nothing would please me more than to see FDA approve TiVo in July. I can tell you now that there is less than 1% of that happening. If you watched the ODAC webcast, you will know what I mean. There was terrible communication and cooperation between FDA and aveo. Aveo should have known better.

      Also, the article you posted was written by Chris Rees (tenstocks) a few weeks ago. Fox likely just redistribute it.

    • I remember the VNDA story. One day after hours the stock jumped 6 fold as I remember. Can you tell us more about the FDA story involving VNDA? Why did they reject it first and approve it later? what was the indication they were targeting?

      Sentiment: Buy

      • 1 Reply to ml_expert
      • Here is some info. Aveo is in better shape because it had about $192 million in cash and cash equivalents at the end of March. glta
        Hell froze over Wednesday night, right before a squadron of flying pigs took to the sky. These things must be true because the U.S. drug regulators also approved Vanda Pharmaceuticals' (VNDA) treatment for schizophrenia.

        The surprising -- some would say shocking -- approval of Vanda's drug Fanapt by the Food and Drug Administration sent shares of the company leaping more than 800% in Wednesday's after-hours trading session to just under $10 a share.

        And no, that's not a typo. 800%. You read that correctly.

        Wall Street had long ago left Fanapt for dead after the FDA rejected the drug in July 2008. The "not approvable" letter issued by the FDA at that time raised concerns about the efficacy of Fanapt and asked Vanda to conduct a new clinical trial and collect additional safety data.

        Vanda didn't run a new clinical trial for Fanapt, choosing instead to resubmit the drug to the FDA last November with additional data from its existing clinical trials.

        To say that investors considered this strategy to be long shot would be an understatement. Vanda's stock price fell well below $1, which valued the company at less than its cash on hand. Analysts either dropped coverage or downgraded the stock to a sell. The company was forced to lay off employees and cut back on other drug research programs.

        On top of all that, activist hedge fund Tang Capital Partners bought up 3.96 million Vanda shares, or just under 15% of the company, and started a proxy fight for board seats in order to force Vanda to shut down and liquidate the remaining assets back to shareholders.

        Sentiment: Strong Buy

    • Part 2 from Fox:
      That said, in our view, the real superiority of Tivozanib comes not only with its PFS data but with its tolerability and safety. RCC patients on Sunitinib endure a wide range of toxic side effects. In the COMPARZ study, patients reported a preference for Pazopanib over Sunitinib because of a more favorable side effect profile.
      In the PISCES study 70% of patients preferred Pazopanib over Sunitinib. Yet, when the ODAC reviewed Pazopanib for approval, the main concern of the panel was for toxicity—specifically liver toxicity. Indeed, the current labeling for Pazopanib contains a box warning regarding episodes of fatal hepatotoxicity.
      As the FDA point out in the Pazopanib briefing document “drugs possessing less hepatotoxicity than pazopanib in other settings (non-cancer therapeutic areas) have been withdrawn after being marketed because of fatal hepatic failure.”
      In the COMPARZ study, 44% of patients on Pazopanib required dose reductions and 24% dose discontinuations due to adverse events. In the TIVO-1 study 12% of patients on Tivozanib required dose reductions and only 4% required dose discontinuation.
      When we look at PFS and OS, RCC patients are now living a longer life than a few years ago. But as survival lengthens, the quality of that additional life becomes more relevant. The treatment related adverse event data suggests Tivozanib may offer the best quality of life yet.
      For the investor, global RCC pharmaceutical sales are running around $2 billion a year and climbing. They rose 17% from September 2011 to September 2012. In the US, sales grew 33% over the same period. The sales growth drivers include expanded treatment options, price increases (in the US), general population growth, and an increase in RCC incidence.
      According to Pfizer’s 10K filing with the SEC, Sunitinib (Sutent) had sales of over $1 billion in 2012. Decision Resources, a research and advisory firm, forecasts that Pazopanib will reach annual sales of $640 million by 2018 as it

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