Vivus (VVUS) -6.2% premarket after Jefferies downgrades shares to Underperform, citing generic...


Vivus (VVUS) -6.2% premarket after Jefferies downgrades shares to Underperform, citing generic competition. While investors have been concerned about patents for the weight-loss drug Qsymia, the firm thinks doctors may choose to prescribe generics since branded Qsymia is unlikely to be covered by payors and the two generics will be more affordable for patients.

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Comments (22)
  • MexCom
    , contributor
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    Old news. No doctor would risk his practice to prescribe it. Need to prove that a doctor would do so by posting his remarks, LOL.
    17 Aug 2012, 09:31 AM Reply Like
  • phemale60
    , contributor
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    VVUS wouldn't have gone thru years of research and trials, adcomms and FDA if doctors wouldn't prescribe it. What would be the point? Jeffries upgraded VVUS recently and they knew about "generic risk"! Lazard, JPMorgan and others upgraded -- what is Jeffries' motive?
    17 Aug 2012, 10:15 AM Reply Like
  • MexCom
    , contributor
    Comments (3069) | Send Message
     
    Doctors are very protective against law suits. I just can't imagine anyone would write a prescription for an off-label use. Especially so now that the VVUS drug has FDA approval for the exact formulation an pill dosage. If anything goes wrong with the patient, he would lose his ability to practice medicine. The challenge is for Jefferies to produce the comment from any doctor who would risk doing this just to save the patient some money for the drugs.
    17 Aug 2012, 10:35 AM Reply Like
  • billchristie
    , contributor
    Comments (23) | Send Message
     
    $VVUS. Doesn't anyone at Jeffries possess a PharmD or at least know how to work a Bunsen burner? Suggesting Physicians are willing to concoct a "Qsymia Cocktail" and risk potential litigation is at best unethical. This is Jeffries using their misplaced Influence, Ignorance, and Ineptitude to "inform" investors. FUD in action,while in the process severely hurting investors and a fabulous well researched drug.
    17 Aug 2012, 10:48 AM Reply Like
  • Rx Stocks
    , contributor
    Comments (120) | Send Message
     
    Keep in mind, both drugs are formulated in lower doses in Qsymia than the already prescribed individual drugs. It is unlikely that cheaper generic combinations will compete with Qsymia sales.

     

    http://seekingalpha.co...

     

    Sometimes pills can be split easily and liquid formulations are easily titrated, I doubt that will be the case with replacing Qsymia with generic topiramate and phentermine.
    17 Aug 2012, 12:34 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    The two drugs have been prescribed by doctors, so I've read, for weight reduction for some time but Vivus had the "animal spirits" (Kudlow's favorite term) to formulate the two drugs into a marketable named brand. They've jumped through all the hoops, trials, adcomms, tolerated all the positive/negative hoopla yet still standing with one competing drug company Arena. One has to wonder why the day after Arena brought down some by Jim Cramer, Jeffries leveled the playing field by downgrading Vivus, especially since "generic risk" has been known for months. Looks like a game to me, at our expense.
    17 Aug 2012, 12:54 PM Reply Like
  • tmbrcv
    , contributor
    Comments (26) | Send Message
     
    Another question would be how are the Drs insurance policies T's & C's written, would doing what is described by Jefferies invalidate the policy coverage or in anyway transfer any amount of the liability from the insurance company back to the Dr.
    17 Aug 2012, 02:28 PM Reply Like
  • MexCom
    , contributor
    Comments (3069) | Send Message
     
    The Jeffries premise is that "payors" will want them to switch to generics. The doctor still has to write the prescription and stick his neck out for the off label use. I don't believe any medical insurance plan that offers a pharmaceutical benefit would encourage the off label use of any product marketed with an FDA approval or recommend taking an over the counter product. They too would face liability if any harm came to the patient.

     

    My Blue Cross Blue Shield mail order prescription plan provided by CVS Caremark has always filled any prescription written by my doctor. I’ve had problems with pre-approvals, controlled substances, etc where additional documentation was always provided with the effort to provide me with the best medical care. I can’t imagine with the need to decrease obesity disease that a health insurance company would be an obstacle to the end result of a healthier population and overall reduced claims against the insurance.

     

    The market for these products is huge. Approximately 1/3 of the U.S. adult population is obese according to the CDC.

     

    http://bit.ly/OvWqVn

     

    If 100 million Americans are obese and if only 5% choose to take Qsymia at a dosage of 1 pill/day @$4 that would be $7.3 billion of a market the first year. Each additional percent would be $1.46 billion. This is just for the U.S. population that is only a small fraction of the world population. This drug will have a larger market than Viagra. The profitability of it for such a small company like Vivus is simply tremendous.

     

    The Jeffries pan this past week has offered a great opportunity to buy more shares on the cheap. I added to my position. Normally I would not expose my investment risk to more than 2% to any one company. With my confidence in the success of this product, VVUS is now 2.8% of my total investments. The increase was due to my share purchases on Friday (Aug. 17) I bought early in the day and again have a profit in my IRA VVUS position. All I can say is thank you Jeffries for making the stock so cheap.
    18 Aug 2012, 07:36 AM Reply Like
  • MexCom
    , contributor
    Comments (3069) | Send Message
     
    Thomas Wei has been wrong before on his analysis of weight loss drug companies. During August in 2010

     

    "http://bit.ly/TNW813

     

    << Jefferies analyst Thomas Wei conducted an alternative analysis of available data and believes that Arena's data doesn't rule out heart-valve risk to a level wanted by the FDA. He said he believes his method will be preferred by the agency over the company's, citing two guidance documents from the agency and feedback from an FDA consultant statistician..>>

     

    ARNA's diet drug has since been approved by the FDA.
    19 Aug 2012, 03:06 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    Amazing Jefferies can be taken seriously about VVUS -- they are the underwriters for Arena:

     

    http://bit.ly/OFXMgq

     

    among many other articles.
    20 Aug 2012, 08:26 AM Reply Like
  • richpeople
    , contributor
    Comment (1) | Send Message
     
    Let's put things into perspective in regards to a drug’s pharmacokinetics (Absorption, Distribution, Metabolism and Excretion = ADME):
    1. A combination drug such as Qsymia (phentermine and topiramate) is formulated together because of its desired synergistic effects. This means that when given at a specific dose, the drug above is more effective on weight lost than when each component is given separately.
    2. One cannot simply prescribe two different drug components (phentermine and topiramate) separately and hope that they will have the same effect as a combination drug (Qsymia) because they body will ADME them differently. In addition, there is no evidence or study to support the safety or effectiveness of the drugs when given separately at the same time. This is because the dosage and formulation are different for the individual drug components than that of the combination product (Qsymia). Without proper clinical trials or evidence-based studies, no healthcare providers will prescribe two different drug components separately to a patient because the effectiveness, safety, adverse effects and interactions between those products are UNKNOWN and may harm their patients.
    3. Qsymia is formulated as an extended release drug which means it dissolves in the body slowly over time and has been tested and approved by the FDA. Phentermine and topiramate is not available as extended release products which may results in patients experiencing much greater adverse effects, ineffectiveness or discomfort. The dosage formulations for Qsymia (phentermine/topiramate) respectively are: 3.73/23, 7.5/46, 11.25/69 and 15/92mg. For phentermine product alone, it is 37.5mg. For topiramate product alone, they are 25, 50, 100 and 200mg. Clearly one can see that there is no equivalent dosage between the individual product (phentermine or topiramate) and the combination product (Qsymia). More importantly, there is evidence-based practice that Qsymia is safe and effective while there is absolutely no evidence of safety or effectiveness for the two individual products given separately at the same time.
    4. Finally, convenience is a big factor for many patients, especially those on many medications as are expected with overly obese individuals. This means that these patients as well as any other patients would want to carry just one pill bottle in their purse or pocket instead of two.
    24 Aug 2012, 01:17 AM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    Just saw doctors on Squawk Box talking about how obesity is straining healthcare and cost to the country and predicted to be even a worse burden then presently.
    24 Aug 2012, 09:28 AM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    Very true, Phemale...How are you?

     

    Didn't see the Squawkbox piece, but know many people who have gained so much weight, metabolism changes, and difficult to remain constant when they reach plateau....Qysmia & Belviq, at least offer a chance to get the first 10-20 lbs off, follow a new eating & exercise plan, with physician's guidance.

     

    Healthcare costs would dramatically drop, with less diabetes, heart disease, possibly less cancer (according to some reports) & less pressure on those aging knees joints.
    24 Aug 2012, 02:36 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    Yes, so right. I see it everyday -- heavy people straining to walk up subway stairs, or one person taking up two seats on the subway. Never saw this before past few years. Used to be rare - now ordinary!

     

    So hey, we did real good today!!! VVUS was up to snuff!! You see OREX? was up .40!! ARNA did so so -- guess there are some peeved people out there. We all have our ups and downs, have to accept it.
    24 Aug 2012, 04:53 PM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    Phemale,

     

    regarding 1 of our favorites..VVUS

     

    I have been researching past posts & saw article from Seeking Alpha from 2009/ Particularly by posts from

     

    'cadujovne' ( If you view profile...dr of pharmacology, etc on previous clinical trials)

     

    http://seekingalpha.co...

     

    Pretty interesting...I have faith in VVUS
    25 Aug 2012, 07:09 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    Wow, thanks. So easy to get nervous reading all the negative bashing, when looking back one can see the facts that brought VVUS's drug approval! Re-enforcing security in holding!!
    26 Aug 2012, 01:10 AM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    http://seekingalpha.co...

     

    Yes, you saw the background of cadujovne SA writer Spencer Osbourne dated 23 Aug? Go to profile...see comments from 2009?Wow, reinforcing big time
    26 Aug 2012, 02:16 PM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    Yes, people are peeved when emotions+money=blowing off steam( I think someone by the name of grouchie was using my pic for dart practice? ;) Almost took it down...I was even accused by grouchie (not his real name) of being a group using different ID's to post? Really? Okay...back to stocks/drugs, etc. subject...

     

    VVUS & ARNA both did well...looks like a big rally for most all stocks...yeah! I have doubts about OREX, due to some of the cardiac issues raised during Contrave trial. It is (also) a combo of 2 existing generic drugs (bupropion and naltrexone)...but extended release...(Sound familar?) In this case, 1 part is anti-depressant the 2nd part used for alcohol dependence.

     

    There is always room for more to help those struggling with weight gain, morbidly obese. My understanding is all 3 of these new drugs will require BMI of 25-30, or co-morbidity issues, like diabetes, cardiac, etc. to get the RX

     

    I really feel for those people...Their feet must hurt, amongst other things...Think of it..Someone has a bad back, maybe brought on by inactivity, age, use of a drug (such as Prednisone) that contributed to the weight gain (like when Jerry Lewis had some health issues) or added even more weight. If it's hard to move, it's hard to get active enough, adding to frustration...It's as if they try to get up & they are knocked back down. These 2 new drugs, plus doctor, & new healthy eating plan, will be the catalyst that lifts them, so they can move...

     

    All in all...really good news coming down pipeline...
    24 Aug 2012, 05:56 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    You are so right and I admire your compassion. These drugs should give them hope and a new quality of life.

     

    I think I know "Grouchie" -- he's given me a hard time too.
    26 Aug 2012, 01:15 AM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    I think you know grouchie, too...Take with grain of salt...Both Q & A stocks are good...I just didn't buy A, because that's not what I know....IA is probably going to be good, just maybe not as efficient as Q....Me thinks grouchie wants it to rise sooner than later...
    26 Aug 2012, 02:21 PM Reply Like
  • phemale60
    , contributor
    Comments (3026) | Send Message
     
    Oh yeah, he's a real Areniac! And they are loose canons. I've been arguing with him a long time. I've been on these VVUS comment streams since 2010 and the ARNA holders have become more intense with competition. Glad we share the good stuff!
    27 Aug 2012, 10:29 PM Reply Like
  • healthythoughts
    , contributor
    Comments (2988) | Send Message
     
    This is my first year on these msg boards...really something!
    28 Aug 2012, 10:57 AM Reply Like
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