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Other drug stocks reacting after hours to the FDA's approval of Vivus' (VVUS) Qnexa/Qsymia: OREX...
Tuesday, July 17, 2012, 8:14 PM ET
Other drug stocks
reacting after hours
to the FDA's approval of Vivus' (
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OREX Wants to be the 3rd
17 Jul 2012, 08:51 PM
Stephen J Melnykevich
17 Jul 2012, 08:54 PM
And we need 3?
17 Jul 2012, 09:01 PM
Vivus, the company that makes Qnexa/Qsymia..... The drug Fen-phen combined fenfluramine and phentermine one of the two drugs in Qsymia that caused heart valve problems and a lot of lawsuits. I had seen a review where only half the patients lost only 10% of their weight.
Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February. "I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer writes in Tuesday issue of the Annals of Internal Medicine.
I see major problems in the future and lawsuits, especially with the cardiologist statement like “severe, even fatal, consequences...” As a doctor I do a lot of weight loss and I will NOT be prescribing Qnexa to any of my patients, especially when we have Lorcaserin that has fewer side effects and works equivalent and possible even better when combined with phentermine.
17 Jul 2012, 09:34 PM
Dr. John 01 is exactly right. Qsymia is an inherently dangerous drug. Why the FDA approved this drug is beyond me, but they have surrounded it with a REMS that will severely limit Qsymia's use.
So, while VVUS and institutional investors are celebrating FDA approval tonight, you must remember one thing, physicians prescribe medications, and for the most part this is not a drug that they will be comfortable with. It's an understatement to say that the REMS requirements are onerous for Qsymia, and it is mal-practice attorneys dream come true. Belviq will become the drug of choice, both by the patients and their physicians.
17 Jul 2012, 11:16 PM
the sm guy gets the raw deal? the stock goes from 29 to 20 then back to 29 then to 24, why did they wait till after hours??? they kill all the stop orders
17 Jul 2012, 09:42 PM
From another physician, I agree ,will only prescribe Lorcaserin when available.
17 Jul 2012, 09:47 PM
the VVUS drug will only be available via mail order
17 Jul 2012, 10:00 PM
In and out of VVUS several times. I'm very in now and plan to stay awhile. A popular host on CNBC told us to get out and take profits. I don't plan to do that right away. I hope he's wrong. We need these drugs!
17 Jul 2012, 10:05 PM
Whats about the Topamax effect versus the other?
17 Jul 2012, 10:06 PM
Lets all get used to the name change...its Qsymia now, (not Qnexa).
And the article at Forbes was laden with phrases like "birth defects", "contraindicated for people with HBPressure and qlaucoma",
Hah, I'd rather be fat.
Im sticking with Arna. I predicting a 2.00 jump by the closing bell tomorrow, up from the current 10.25.
Breaking 12.00 anyone?
17 Jul 2012, 10:08 PM
Best thing for Vivus and us long term people is to have it bought out by a co. that has the marketing ability in place. Don't forget Vivus has Stendia too which needs good marketing to knock Viagra down a few pegs.
17 Jul 2012, 10:10 PM
I do not see a problem having competition in the marketplace. The product approved today has so many negative restrictions I do not see how it can stack up against Arena's product. VVus products is extremely limited in its marketplace in this country and will get approval in the EU and surrounding countries. Therefore I see them as a flea on the back of an elephant. What will hurt Arena early on are the hedge funds and unscrupulous market makers that want to see VVUS succeed over ARNA. Theses hedge funds and market makers will run for the hills at the first sign of a lawsuit against against VVUS.
17 Jul 2012, 10:18 PM
Wow, the FDA approved this? With all these restrictions and REMS? I was hoping for a two-way battle with VVUS and ARNA. IMHO--ARNA wins by a first round knockout.
17 Jul 2012, 10:23 PM
most shareholders of arna did not expect approval of vvus product because of several reasons, the most obvious one, was that fda would not approve two related drugs during two months period?? why the heck they waited till late evening. they must be indecisive? i was planning to sell 50% holding of arna, and grab some vvus. depending on the pricing for first couple of hours tomorrow, i still might do that otherwise sleep on arna for a while.
good luck everyone.
17 Jul 2012, 10:55 PM
I'm holding ARNA and have traded VVUS today! Looks like I made the right choice!
17 Jul 2012, 10:59 PM
What does this do for ARNA stock price tomorrow?
18 Jul 2012, 12:47 AM
What does this means for ARNA stock price tomorrow?
18 Jul 2012, 12:49 AM
It most likely will drop in the PM or first hour of trading, some people panic, some people find it an opportunity to short. arna.
some people will try get out of arna and go for orex, expecting the same run up on orex when lorcasercin was approved.
All these may lead to high selling, driving down the price..
Whether the stock will come back up, it depends on the sentiment of the market.
For example, if people start to be taken back by the side effects of the Qsymia, then stock of arna may rise back. (Regarding the restrictions that FDA put on QSYMIA, you have to do your own diligence by listening to the conference call in VVUS website, i slept really late, and cant be bothered to listen to it.)
If the restrictions, and the general sentiment of the market is that even though Qsymia was approved but it is really hard for doctors to prescribe, then arna will start popping. Because many believe that Lorcaserin should be prescribed first and if patients show no effects, doctor then will move on to Qysmia. Market share of Lorcaserin is not affected, vvus drops, arna goes up. (THis is for long term)
arna may not rise back, and vvus may pop, if the REM gave FDA enough confidence that Qsymia's benefits outweight its side-effects, and doctor can prescribe them without much cautious..
once again, you have to do your own research, now it will be mainly on the restrictions FDA posts on Qsymia, as it is the deciding factor on ARNA and VVUS stock price..
Just some of my humble opinions, have a nice day
18 Jul 2012, 01:32 AM
In the coming days when all the dust goes way all who try to keep ARNA down will have to buy it at a higher price.Arena has the better product by far while VVUS has two old problem drugs together. have been watching the markets and the all people in the media day after day speak negative about ARNA. Now all of them will see in the coming days and months that ARNA will be the winner by far.
18 Jul 2012, 02:17 AM
I am a Pharmacist and Arena has the best drug by far. Just hold on you can not lose.
18 Jul 2012, 02:18 AM
Re: The significance, or rather insignificance, of Qsyemia approval 18-Jul-12 03:07 am
Posted from YMB......
Now let’s get to the meat of the restrictions:
The FDA press release simply said that reproductive age women should have a negative pregnancy test before starting Qsyemia. However, we must always read between the lines and it is clear in the following statement from the Prescription Label:
“Qysemia REMS. Because of the teratogenic risk associated with Qsyemia therapy, Qsyemia is available through a limited program under the REMS. Under the Qsyemia REMSS, only certified pharmacies may distribute Qsyemia.”
Interpretation (based on the Accutane REMS to avoid fetal exposure):
As a requirement of the REMS program, access is restricted. This means that all patients, prescribers, dispensing pharmacies must register and be active in this REMS program which is designed to eliminate fetal exposure to Qsyemia. This REMS will require all patients meet qualification criteria and monthly program requirements (eg, pregnancy testing). What will likely be included will be a requirement that providers can only prescribe a maximum 30-day supply at each monthly visit and they must counsel patients on this REMS program and there will be a required confirmation of counseling via an automated system. So for each month of therapy, female patients must return to their physicians for evaluation, counseling, education.
Usually what is required is that women will need to have two negative urine pregnancy tests (there are false positives and negatives with urine pregnancy tests) before receiving the initial pregnancy test. Usually the second pregnancy test must be conducted at a certified laboratory specified under the REMS. Furthermore, what will likely be required is that physicians must certify expertise in the diagnosis and treatment of obesity, and knowledge of the risk and severity of birth defects.
I have gone through the experience. What will happen before an obesity expert prescribes and commits himself or herself to this REMS they will exhaust all available methods and therapies for obesity first. I can guarantee they will be reluctant to commit to such intensive surveillance just as are dermatologists with Accutane.
As part of the program Accutane patients also have a large amount of paperwork to fill out and they have to watch a video on birth defects so that they understand the risks. By the way, I have firsthand experience with this process.
For more information on the Accutane REMS – which will be very similar to what is required for Qsyemia – go to:
This is time-consuming, labor intensive, and expensive.
Furthermore, under the Pharmaceutical Lexi-Comp Online Drug Interaction Monograph the combination of topiramate and contraceptive pills have a Risk Rating of D: Consider therapy modification – contraceptive failure is possible (reliability rating: good).
Patients should be advised to report any changes in bleeding patterns but that loss of contraceptive effectiveness can occur without any change in bleeding pattern. The FDA is aware that topiramate can decease the serum concentration of both the estrogen and progestin components of the birth control pills and therefore contraceptive failure is possible. This will have to be disclosed to the patients.
Another serious potential problem is that it is recommended that Qysemia be discontinued immediately in the event an unplanned pregnancy occurs. Now how will they harmonize the following warning in the Prescription Label with this recommendation – to not stop Qysemia abruptly because this may precipitate a seizure. Did they somehow forget this very important detail?
professional comments from YMB
18 Jul 2012, 06:41 AM
You said it and I totally agree. As a doctor who treats a lot of weight loss patients I will not prescribe or even make a referral to another doctor to prescribe. There are serious issues with this drug and Dr. Daniel did a good job at covering some major issues.
Not to mention the WARNING statement by Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February. "I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer writes in Tuesday issue of the Annals of Internal Medicine.
I really find it hard pressed for a prescribing physician to risk his license and a potential law suit on a drug like this.
An article had this statement “Doctors tested the pill in more than 4,430 overweight and obese patients. About half lost 10 percent of their weight -- enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death. “
A 10% loss in body weight in 50% of the patient population (as described in the article above) is not good numbers in my opinion. There are safer and better methods to lose 10% body weight with far less risk. My personal numbers in my clinic are far better with little to no side effects.
18 Jul 2012, 09:18 PM
If doctors won't prescribe it and the company has no sales force, why is stock higher?
18 Jul 2012, 09:03 AM
Is this the stock that some the OFFICERS were dumping some of their shares over the past few weeks?
18 Jul 2012, 09:23 PM
Ah, Yes DocJohn01. That would be the one!!!!! They knew what was coming and why.
19 Jul 2012, 01:20 PM
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