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Avanir Pharmaceuticals, Inc. Message Board

  • superichkid superichkid Oct 17, 2013 10:53 AM Flag

    Cowen - Oct. 17, 2013 - ANDA Filing Trial Over: Settlement? or Ruling?

    Yesterday, we had the opportunity to catch up with Avanir management regarding the status
    of the legal trial surrounding the ANDA filers which wrapped up on Tuesday of this week.
    Post-trial briefings will be submitted to the judge by November 15th. Based on the briefings,
    the judge will most likely render a decision by the end of December when the 30-month
    stay period ends. The judge's decision will be communicated to lawyers first, then to the
    companies. Thus, the final press release date may spill into the beginning of January 2014.

    The company has stated that nothing has been unexpected in the trial and that the
    ANDA filers' claims are mostly based on a prior outlier case in which a single patient was
    administered a lower dose of Nuedexta with therapeutic effect. AVNR believes that a single
    outlier case does not merit the claim of "prior art". The company communicated to us that
    Judge Leonard P. Stark presided over a similar case involving ANDA filers who attempted
    to use three outlier cases to make the case for "prior art". The judge ruled against them and
    the company is confident that the judge will not contradict himself in the current case. The
    company told us that should the judge render a decision against the company, that AVNR will
    appeal the case.

    Recall, the patents in dispute are the Pharmaceutical Composition '155 patent that expires
    in 2016 and Method of Treatment '242 and '484 patents that expire in 2023 and 2026,
    respectively. While we do not rule out the possibility of a settlement given the subtleties and
    the stakes involved in the trial, based on our discussions with company, we believe AVNR will
    likely come out a victor in the case. We continue to be bullish on the outcome of the trial and
    reiterate out Outperform rating on AVNR shares. Price Target: $12.

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Cowen or an anonymous poster with an agenda?

      Sentiment: Strong Buy

    • Cowen positive comments...

      Sentiment: Strong Buy

    • "We continue to be bullish on the outcome of the trial and reiterate out Outperform rating on AVNR shares. Price Target: $12."

      Sentiment: Strong Buy

    • greatdayforinvestments greatdayforinvestments Oct 21, 2013 11:23 PM Flag

      "We continue to be bullish on the outcome of the trial and reiterate out Outperform rating on AVNR shares. Price Target: $12"

      Sentiment: Strong Buy

    • $12.00 Price Target, thanks Cowan for the Summary!

      Sentiment: Strong Buy

    • Price Target $12.00. The anonymous Short Bashers thank you for the cheap shares..

      Sentiment: Strong Buy

    • "Avanir will likely come out a victor in the case" but then again the anonymous short bashers would like you not to read that portion...

      Sentiment: Strong Buy

    • "The company communicated to us that
      Judge Leonard P. Stark presided over a similar case involving ANDA filers who attempted
      to use three outlier cases to make the case for "prior art". The judge ruled against them and
      the company is confident that the judge will not contradict himself in the current case. The
      company told us that should the judge render a decision against the company, that AVNR will
      appeal the case."
      These comments said to be by Avanir strike me as legally unwise. I don't think you want to make public statements prejudging the judge's decision (saying he would be "contradicting himself" if he views an outlier case as "prior art") and saying you will appeal if the decision goes against you without even knowing the substance of the decision. I think most Judges would look upon such comments unfavorably, although theoretically the decision should be the same, based solely on interpretation of the law and not emotion.

      • 1 Reply to rayonmanl
      • "I think most Judges would look upon such comments unfavorably, although theoretically the decision should be the same, based solely on interpretation of the law and not emotion."

        Avanir has stated in previous conference calls that they will vigorously defend their patents, and that Avanir is confident their patents will uphold in a court of law; in so many words... Common sense Avanir will appeal the decision if Judge Stark were to invalidate all 3 patents... but then again, we all know that Judge Stark ruled in Avanir's favor on ALL the Markman Rulings in 2012...

        Sentiment: Strong Buy

    • Yep, quite a heads up...

      Sentiment: Strong Buy

    • "...The company has stated that nothing has been unexpected in the trial and that the
      ANDA filers' claims are mostly based on a prior outlier case in which a single patient was
      administered a lower dose of Nuedexta with therapeutic effect. AVNR believes that a single
      outlier case does not merit the claim of "prior art". The company communicated to us that
      Judge Leonard P. Stark PRESIDED OVER A SIMILAR CASE involving ANDA filers who attempted
      to use three outlier cases to make the case for "prior art". The judge ruled against them and
      the company is confident that the judge will not contradict himself in the current case...."

      GALDERMA VS. TOLMAR LABS is that case...

      "...The court (Judge Stark) disagreed that this reference was significant, because while the data sheet identified an identical excipient gel, it did not identify the use of a 0.3% adapalene formulation. The court next considered a prior art Phase I clinical study (“Vershoore”) conducted in 1997 where a 0.3% adapalene solution was applied to the backs and forearms of healthy patients. The court agreed with Galderma that the fact that the 0.3% solution did not result in significantly higher side effects during the clinical trial than the 0.1% solution would not have been obvious to one skilled in the art because the test subjects and area of treatment (back vs. face) were different from the population and disorder treated with Differin..."

      Sound familiar??

      Generics....LOSE!

      Sentiment: Strong Buy

      • 1 Reply to placesontherun37
      • Galderma vs. Tolmar Labs...analysis thereof, continued:

        "...The court found that the prior art references taught away from increasing the concentration of adapalene from 0.1% to the claimed 0.3% formulation. Specifically, the court identified studies where an increased irritation was observed when adapalene concentrations were increased from 0.03% to 0.1%. The available prior art references in combination seemed to indicate that tripling the then-accepted 0.1% concentration adapalene formulation would have resulted in a substantial increase in irritation. Coupling the aforementioned findings with two secondary considerations of non-obvious—unexpected results and commercial success—that the court found to be well supported, the court held that the asserted claims were not obvious..."

        Again, sound familiar? Generics....LOSE!

        Sentiment: Strong Buy

    • View More Messages
 
AVNR
12.94-0.26(-1.97%)Oct 31 4:00 PMEDT

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