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Spencer Osborne

 
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  • Belviq - 2015 Sales Expectations [View instapost]
    Jakes...

    Not really singling out wei. He happens to be the analyst with the most bullish outlook. His latest report is looking for about 1 million bottles to sell
    Dec 11, 2014. 08:05 AM | Likes Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    Jakes....

    I would say that they will be mulling it over after q1. It all depends on how well each. Of these sell
    Dec 11, 2014. 08:01 AM | Likes Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    Jim...

    We simply do not know. maybe it was more strenious....maybe it was so simple that people did not like it because they were not feeling anything.

    The point is that that study essentially spins data. when data is spun it weakens any debate. When holes can be pointed into something like this, it makes the company look bad.

    Example. You presented this spun data. I showed you how it may essentially be meaningless. I have brought this up with you before when you compare responders to the total averages. I am not trying to be a jerk. I am actually trying to be helpful. If data is spun and has holes in it, it takes away from the credability of the presenter as well as the company. Simply stated, don't compare responders with one drug to the entire pool of the other, and do not take what on its face is a poor study and a poor conclusion and use it to try to make an example.

    I saw the presentation you refer to. It is one persons "study" of the phase III. It is a piss poor study and a piss poor conclusion. Any reasonable person could poke holes in the conclusion in a matter of one or two minutes. That "study" of the data is about as apples to apples as the sun and the moon.

    You can refer to it if you like, but in doing so you are placing your faith in a scientifically weak, weak, weak, weak, weak, weak assessment of the various data.

    personally, when I see presentations like that I laugh them off for the nonsense that they tend to be.

    What types of data can be drawn from the same study?

    - The placebo group of Contrave was 80% more likely to leave the trial due to "adverse reactions

    - People on contrave are more likely to lose 5%

    - People on contrave were more likely to lose 10%

    - People on Contrave were more likely to have an adverse reaction

    - people on Contrave are less likely to progress to diabetes.

    It is ironic. I will be crucified for pointing out the weakness in this study when everyone that read it knows the weakness. The study, in my opinion, was a very poor spin job
    Dec 10, 2014. 07:37 PM | Likes Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    Mark....

    Not sure where you are going with this. Are you aware that many drugs have black box warnings?

    As I said, every antidepressant has had one since 2004.

    Top selling drug in 2013 was Abilify from Otsuka. Had $1.6 billion in sales - has a black box

    Third best selling driug in 2013 was Humira from AbbVie. Had $1.5 billion in sales - Has Black Box

    Fifth best selling drug during 2013 was Advair from GSK - Had $1.2 billion in sales - Has Black Box

    Sixth best selling drug in 2013 was Enbrel from Amgen - Had $1.2 billion in sales - Has Black Box

    seventh best selling drug in 2013 was Cymbalta from Eli - Had $1.1 billion in sales - has black box

    eighth best selling drug in 2014 was remicade - Had $1 billion in sales - Has black box

    Six out of the top 10 selling drugs in 2013 carried a black box warning. In my opinion many people that are active on the net play the black box card as something much bigger than what it is. Usually this dynamic is something that is banter between investors in competing companies.
    Dec 10, 2014. 04:25 PM | 1 Like Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    To head off a firestorm debate between Contrave fans and Belviq fans....


    BELVIQ
    8.6% quit from belviq arm
    6.7% quit from placebo arm

    47.1% lost 5% (22.4% lost 10%) vs. 21.6% in placebo (8.7% lost 10%)

    ----------------------...
    Contrave saw this COR study:

    24% in contrave quit from adverse reactions
    12% in placebo quit for adverse reactions

    42% lost 5% (21% lost 10%) vs 21% placebo (7% lost 10%)

    COR BMOD was this.

    57% lost 5% (35% lost 10%) vs 43% of placebo (21% lost 10%)

    To try to compare the chances of quitting from an adverse reaction to weight loss of 5% may appear interesting, but does it tell a whole story or just part of one?

    1. The placebo quitters was highest with Contrave, and least with Belviq. This factor would seem to indicate that there was an aspect of the trial design outside of the drugs that had the placebo quitting at a rate 1.8 times higher than Belviq for Contrave. This is relevant because the way the data is presented does not illustrate these aspects of the data, but must realistically be considered.

    2. Does the higher placebo quit rate translate to a possible higher quit rate in the drug arm? I would say that a person twice as likely to have an event with high dose qsymia vs. placebo. I would say that a person is also twice as likely with Contrave. I would say that a person is only slightly more likely in Belviq. That does demonstrate that Belviq would have the mildest side effects. However, how does that compare to weight loss? What is more important....losing more weight or possibly having more side effects? That may differ from person to person.

    3. What happens when the criteria is aimed at 10% weight loss instead of 5%?

    From a medical standpoint the best drug for a patient is the one that works best for that patient. In that context, I am glad they are all available.

    From an investment standpoint, the best drug may not really matter. Which company can sell the most and bring about the best chances of better portfolio profits?
    Dec 10, 2014. 04:04 PM | Likes Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    Jim....

    Contrave does have an easier path with insurance, as well as price point.

    I do not want to get into a debate about this study about these ratios. There are other considerations that go far beyond that cursory analysis that the doc made.

    A few clarifications:

    You use adverse event in your description, whereas the studies use adverse reactions. There are two different definitions.

    The placebo group quit rate was much different. Was that related to a more stringent non-pill program? For example, 6.7% of patients in Belviq placebo quit, while 12% in the Contrave placebo quit. In theory, the pills had nothing to do with these people quitting in placebo, so what caused the substantial difference? Was the Contrave diet and exercise regiment mare harsh causing people to quit? We do not know, because there was no direct comparison.

    My opinion is that the study you are referring to is a very, very, very, very, very poor study to place a debate on because it is so easy to punch holes into. The same is true when people try to compare "responder data" to the data of an overall pool comparing both responders and non-responders. My opinion is that these types of stances, when taken, fool the naive, but become ammunition for those that think more deeply.

    Dec 10, 2014. 03:44 PM | Likes Like |Link to Comment
  • Assessing The Beginnings Of The Orexigen Launch Of Contrave [View article]
    Mark....

    This is not a medical article. It is an investment article. Should I mention all of the side effects on each and every anti-obesity drug. I do not really like the side effects of any of these. The black box exists because the drug contains Welbruton (an anti-depressant). All anti-depressants got black boxes back in 2004.
    Dec 10, 2014. 03:31 PM | 1 Like Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    dax....

    The material information of the label would be identical. If there is a difference, and the sample labels are the bad labels, then we would need to consider an early demise to the sample program. The FDA and DEA have pretty specific rules about sampling a scheduled drug. If that gets messed up, then there could be hell to pay. All I can say is that they better have all of the paperwork ducks in a row. If anything is lax, it would not be pretty if it involved free samples.

    It is a scary thought.
    Dec 8, 2014. 11:15 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    jakes....

    Any setback is disappointing. I am not going to sweat the issue unless it demonstrates that it is bigger than we thought. The company stated it is small, limited, and should not impact sales. If that turns out not to be the case, it will be a setback to confidence in what the company tells us.

    My opinion is this....

    Address the issue. Preoperly frame expactations.

    They have addressed it...hopefully they framed expectations correctly.

    From what I outlined, Eisai will pay NOTHING. This is the negligence of Arena. By contract, Arena will bear the costs. If Eisai were to pay half of this and I were invested in eisai, I would sell every share I had and then short 100 times more than I held. This is a labeling issue and Arena is responsible for labeling.

    The terms....

    Any recall or withdrawal expenses shall be shared equally by the Parties; provided that to the extent any such recall or withdrawal resulted from a Party's material breach of its obligations hereunder or the negligence or willful misconduct of such Party or any of its Affiliates, such Party shall bear the expense of such recall or withdrawal to the extent of its or its Affiliates responsibility.

    Arena's negligence....Arena pays
    Dec 8, 2014. 11:11 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    vito....

    This assumes that Teva wants to further invest into a product that is seeing mediocre sales.

    Arena has made no real indication of disappointment...though I think everyone expected more in the sector.

    Bottom line is that sector is weaker than many hoped for.

    Teva buying anything at this stage....IMO....nope
    Dec 8, 2014. 10:12 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    Jakes....

    Arena is responsible for manufacturing, bottling, and labeling. Arena is responsible to create a finished product to Eisai. If there is a labeling issue, it is Arena's issue. In no way does this fall onto Eisai.

    Arena owns the manufacturing facility and operates it. I would be stunned if a third party was involved. Even if there was a third party, they would be under Arena's supervision and not Eisai.

    The term "negligent" may seem strong, but that is how it would boil down from a contractual standpoint. We have three choices. material breach, negligence, or willful misconduct.

    Why would Eisai pony up any dollars for this. The manufacture, bottling, etc. is Arena's responsibility. In essence they were negligent in their side of the duties.
    Dec 8, 2014. 09:14 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    dax.....

    second question first.

    Brazil and the Swiss collaborate on several things.

    Resoving tumors.....It can only come with time. New study's with Rats can perhaps help.

    I will share some of my thoughts with you offline.
    Dec 8, 2014. 08:38 PM | 1 Like Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    Dax....

    I get it.....BUT....

    Clearly these issues were not addressed because the Swiss had similar concerns. Now it appears that Canada will join the pack.

    I suspect most of this witch hunt simply is the overwhelming desire of some to minimize these issues.

    The next shoe may be Brazil.....we shall see
    Dec 8, 2014. 08:24 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    sharinky....

    Previous applications were the EU application and the Swiss application.

    Arena has stated that the Swiss concerns were similar to the EU. That has been well established for quite some time.

    The EU issues were tumors, psychiatric, and cardio.

    This is pretty simple.

    Cardio has been an issue with ALL of the obesity meds. ALL of them have post marketing requirements surrounding cardio testing.

    I realize that some folks want to pretend that this is not the case, but it is. the EU made it crystal clear.

    Your opinion seems to be that the only concern is tumors......That is fine. You will certianly find a few dozen message board posters to believe that. heck, you have convinced the same few dozen that I delete comments even though I have no ability to do that. See what happens when people let their imagination take control over rational and logical thought.

    The EU offered its stance.

    Here is what Arena stated Just last month:

    "With respect to the European Union, in 2013, the EMA’s CHMP identified major objections related to nonclinical and clinical issues, including tumors in rats, valvulopathy and psychiatric events, and the CHMP requested that we further justify BELVIQ’s overall benefit-risk balance taking these issues into consideration. The major objections needed to be addressed before the CHMP could have recommended BELVIQ for marketing approval in the European Union. We did not believe we could resolve the major objections related to the results of nonclinical studies prior to the time we expected the CHMP to issue its final opinion, and, therefore, we withdrew the BELVIQ MAA for the European Union. We also previously filed an MAA for approval of BELVIQ in Switzerland, and Swissmedic provided us feedback that included major objections that were similar to those identified with respect to our MAA for the European Union and determined not to approve our application. We expect Eisai to potentially submit for regulatory approval in Europe at a later date, but BELVIQ may not be submitted for regulatory approval in Europe when expected or ever."

    By the way....please note that Arena stated nonclinical and clinical.


    Dec 8, 2014. 07:51 PM | Likes Like |Link to Comment
  • Arena's Belviq - Regulatory Update And A Recall [View article]
    Hopefully this will close the issue regarding the bulk of discussion in the comment section:

    CHMP stated:

    "Based on the review of the data and the company’s response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Belviq could not have been approved for weight control in obese and overweight patients."

    Translation - CHMP reviewed the data as well as the responses to questions about the data, and determined that the drug could not have been approved. This would seem to indicate that more data that shows the benefit of Belviq OR shows the safety with respect to concerns is needed.

    CHMP stated:

    "Although a modest benefit in terms of weight loss was seen in the main studies, the Committee was concerned about the potential risk of tumours, particularly with long-term use, based on the results of laboratory tests."

    Translation - CHMP is of the opinion that the weight loss from Belviq is modest in nature. The committee wants more data about the possibility of tumors with long term use. The data supplied was not sufficient enough to alleviate these concerns

    CHMP stated:

    "The CHMP also had other safety concerns, including the potential risk of psychiatric disorders (such as depression) and valvulopathy (problems with the heart valves), which were seen in some patients during the studies."

    Translation - The data that was presented on psychiatric issues and cardio issues was not sufficient enough to bring about a positive outcome in terms of approval. The answers to questions about these issues were also not sufficient enough to tip the scales to approval. More data will be needed regarding these concerns to demonstrate that they are minimimal, or at least that they do not outweigh the "modest benefit".

    CHMP stated:

    "Therefore, at the time of the withdrawal, the CHMP was of the opinion that the
    benefits of Belviq did not outweigh its risks"

    Translation - There may or may not have been other issues regarding Belviq, but the three main ones were tumors, psychiatric, and cardio. These three alone may be viewed as presenting to much risk vs. the "modest benefit" and therefore the drug application was withdrawn in lieu of getting a rejection.

    Arena stated that the Swiss outlines "similar concerns" and seemed to group Canada into that category as well.

    Thus, more data in support of belviq is needed in order to satisfy these regulators.

    As an aside, would it be possible to gain approval for short term use? For smoking? These are things that investors can contemplate.

    Cheers All!
    Dec 8, 2014. 04:59 PM | Likes Like |Link to Comment
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