A bevy of Street analysts weigh in on Vivus' (VVUS +11%): Cowen says Qsymia has "considerably...

A bevy of Street analysts weigh in on Vivus' (VVUS +11%): Cowen says Qsymia has "considerably better" efficacy over Arena's (ARNA -7.5%) Belviq. Brean Murray says the approval came clean, without any harsh restrictions. Jefferies - after initially being negative on the stock - calls the FDA decision a "major win" for the company and upgrades the shares to Underperform. Wells Fargo is a bit more cautious, saying that despite the big win, the company still faces reimbursement challenges, a restrictive distribution network, and patient compliance.

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Comments (18)
  • montanamark
    , contributor
    Comments (1455) | Send Message
    if its so great - why is it restricted to mail order


    what about the contra indications - sound severe to me
    18 Jul 2012, 01:48 PM Reply Like
  • deercreekvols
    , contributor
    Comments (9513) | Send Message
    Analysts weighing in is great, but I am interested in the doctors who will be writing scripts for this stuff. Where are their opinions?


    It seems to me that WFC is taking the correct "show me what you can deliver" approach to this approval.


    Better to be safe than sorry.
    18 Jul 2012, 02:02 PM Reply Like
  • mfm401kvp
    , contributor
    Comments (91) | Send Message
    Analysts only bother with their truth or the talking points. They don't understand the science nor the actual results such as the best efficacy for Q. comes from the highest dose only which is only available after going through 24 weeks of the lower doses without results that would have the patient DQ'd from Belviq after only 12 weeks at its only dosing level. Ooopsss. And I don't make a six figure salary working for these firms. Easy to lie and hide.
    18 Jul 2012, 02:04 PM Reply Like
  • karlis44
    , contributor
    Comments (63) | Send Message
    Dear Seeking Alpha Commentator Friends:
    So how do you feel about the Qsmyia approval? Many were so upset that I thought this was a good med and likely will get approved. Belviq will not get many sales. Since it affects Serotonin  receptors and thereby not good to use with SSRI and other antidepressants. That eliminates a "big and fat" population. The analysts are somewhat negative of the sales of Qsymia. Do not know why many analysts seem uneducated about fundamentals of medicine and science. When those are correctly understood and in place regarding biotech science principles the market will follow over time. Am sure Qsymia will produce great sales numbers.


    BTW: Just do not know why analysts do not get Erifta (Tesamorelin) distributed by Serono-Merck. It melts body visceral fat in HIV Lipodystrophy. Which means also non HIV people would gain same health benefits as off label usage.
    Disclosure: I am a share holder of THER (Theratechnologies, Canada). Have followed the science of most of the GHRH (Growth Hormone Releasing) peptides for many years. Am a member of the Growth Hormone/IGF-1 Research Society since 1998. Likely hGH testing will get some positive results in athletes at the London Games. Since the IOC doping urine tests can now identify the non-native isomers of hGH numbers/ratios. Any questions?


    Karlis Ullis, MD
    Santa Monica, CA 90405
    18 Jul 2012, 02:06 PM Reply Like
    , contributor
    Comments (261) | Send Message
    So if it will not benefit many people did you feel the need to ask the FDA panel why they bothered to approve it?
    18 Jul 2012, 02:52 PM Reply Like
  • @pharmdca
    , contributor
    Comments (400) | Send Message
    Belviq will not get many sales and am sure Qsymia will produce great sales numbers? Wow, these are really stupid statement I heard from a medical professional. Oral Cleft issues, heart issues, and other nasty side effects of Qsymia will be a big obstacle for Qsymia sales. Good luck prescribing Qsymia to your patients and be watchful for future lawsuits.
    Secondly, are you even aware of subtypes of serotonin receptors. If not, please look into it and try to see which serotonin receptor is being targeted by Arna. Thank you
    18 Jul 2012, 05:14 PM Reply Like
  • karlis44
    , contributor
    Comments (63) | Send Message
    Thanks for your inspiration Punjab! Will do my homework on the Serotonin receptor cascades affected by Belviq. BTW: "Arna does not target any thing", It is a Pharmaceutical Company. Please review your comments before submitting.
    Most "interesting for me" to see how angry people can get when they see MD degree. Looks like people just do not have good medical experiences these days. I hear that all the time.
    Best wishes,
    Karlis Ullis, MD
    Santa Monica, CA 90405
    21 Jul 2012, 01:27 AM Reply Like
  • labratsuccess
    , contributor
    Comments (36) | Send Message
    I have read that Phentermine can only be taken for 12 weeks. The problem then would be to stop taking Q and watch as the weight gets put back on over time.


    This seems very counterproductive. Phentermine is also a stimulant no different than Adderall and Ritalin and each state has its own reporting requirements for scheduled drugs, but the real kicker is how long of a holiday is required after the 12 weeks is reached, how is it determined, and the biggest question of all is Q. a drug users can take for a lifetime or is it a shorter term jump starter to get the process going?
    18 Jul 2012, 02:24 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
    "what about the contra indications - sound severe to me"


    Depends on how much you want to lose weight. Life is a series of tradeoffs. In this case you can lose weight but get heart damage. Your choice!!! Ha Ha!! I wouldn't take it myself, but I do own several hundreds share, especially considering half the country is now obese.
    18 Jul 2012, 03:20 PM Reply Like
  • amatta
    , contributor
    Comments (3) | Send Message
    can someone please explain why the insurance companies would choose to pay the premium for this drug instead of requiring doctors to just write Rx's for the two generic pieces??
    18 Jul 2012, 03:20 PM Reply Like
  • MexCom
    , contributor
    Comments (3069) | Send Message
    Dosage is different in the pill. They can't do it. I can't imagine why my insurance would no co-insure the product under a Drs script. They have never rejected a prescription from my doctor for any reason.
    18 Jul 2012, 03:26 PM Reply Like
  • Scrapula
    , contributor
    Comments (4) | Send Message
    Insurance companies usually don't cover weight loss drugs. Physicians write for the generics instead, so the patient can save money. They've been writing for topiramate and phenterimine for years. Drug makers always change the dosage form to get a patent. In this case, going extended release. However, immediate release drugs work better for weight loss. Take 30 minutes before eating and it really cuts your appetite. Topiramate just has a side effect of mild weight loss, but is an anti-seizure med. I don't see physicians writing scripts for Qsymia.
    18 Jul 2012, 05:44 PM Reply Like
  • Foreverlong07
    , contributor
    Comments (77) | Send Message
    Sounds like Wells Fargo is the only one that gets it about Qsymia for a number of the right reasons. Regardless of the few percentage points it has over Belviq, physicians for the most part, will not prescirbe it because of its know liability. Analyst, Brean Murray is absolutely wrong about the REMS for Qsymia. It was very restrictive. He must have just read the some of the highlights. Go back and read it again Brean. The FDA is not stupid. They knew what they were dealing, and they have set Qsymia up for business failure.


    In contrast to Belviq ( a much safer drug that can be combined with Phentimine to achieve a higher level of efficacy), a woman (between the ages of 18 to 45) wishing to take Qsymia will have to submit to an initial pregnancy test, and one each month thereafter, as long as she wishes to take the drug. She, as welll as, male patients will have to have a BMI of 27 or higher, and must also have a co-morbidity of hypertension, diabetes or dyslipidemia. The drug will only be able to be delivered through mail-order pharmacies. Or, you can can take Belviq, with or without the Phentermine, skip the pregnancy tests and the monthly visits to your physiician's office, and take the script to your nearest drug store and have it filled.


    Now, Brean with that said, do you really think that physcians and their patients are going to be bothered with the Qsymia REMS? Or, given the choice say, "I think that I will take Belviq Doc!"


    Believe me the choice is obvious, and if you don't know the right answer, you deserve to lose your money, but you're not going to lose mine. Belviq is not only the right drug...it is the right investment.
    18 Jul 2012, 04:01 PM Reply Like
  • Scrapula
    , contributor
    Comments (4) | Send Message
    Qsymia is just another combo drug. Weight management doctors will prescribe generic phenterimine and topiramate which are dirt cheap. I don't see it making money. Belviq is at least a novel drug. I'm not a stock analyst, just a pharmacist.
    18 Jul 2012, 05:42 PM Reply Like
  • JimmyMack
    , contributor
    Comments (5) | Send Message
    I agree that Qsymia will not be prescribed as readily due to the higher level of side effects. What about the problems of taking Qsymia by women of child-bearing age? That's a problem.


    Belviq seems to be effective enough and SAFE. Arena Pharma also has a distribution partner that has already engaged its forces, European approval on track, and is really a novel chemical entity with huge potential, including that of being prescribed with Phentermine.


    Qsymia looks like a well-groomed dog and Belviq looks like a young thoroughbred racehorse - both getting ready to race.
    18 Jul 2012, 05:50 PM Reply Like
  • Day Trader001
    , contributor
    Comments (779) | Send Message
    You “failed” to mention this one! How about being objective!!!!


    DOWNGRADE: Vivus (VVUS) downgraded by Brean Murray from Buy to Hold.
    BRIEFING.COM – 1:25 PM ET 07/18/2012
    18 Jul 2012, 06:28 PM Reply Like
  • tahalb
    , contributor
    Comments (261) | Send Message
    You all know that some behind the scene game was played all along between the FDA ,WS and VVUS exect. Bribes and some major kick back in the multi million dollar level was handed over ...why would the market react in such a dangerous manner on Tuesday? Why did the FDA Waite till 7 pm to announce thier half assed decision with approval of already previously approved two drugs? This is all a huge game, that the average investor does not even think of it remotely happen, but it does, I lived in DC for thirty years and I know how events such as this do occur. At the end of the day, VVUS and ARNA will go to market, and time will tell as to when WS will pull the rug from under VVUS and turn into ARNA as the real drug to fight (safely) obesity WORLD WIDE.
    18 Jul 2012, 11:27 PM Reply Like
  • cgarrett101
    , contributor
    Comments (19) | Send Message
    In addition to the stimulant, Qsymia contains topiramate (Topamax) which I took for a short time for migraines. Topiramate is also used for seizures. I did not stay on it for long because it made me stupid- sluggish and unable to reason well. Everyone I have spoken with about this drug has had similar reactions. A friend of mine's daughter who took it in high school for seizures was unable to keep up in her math classes, and without topiramate she is brilliant in math. Not sure losing weight is worth stupidity + speed.
    19 Jul 2012, 03:30 PM Reply Like
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