Rx Stocks

Biotech, healthcare, long only
Rx Stocks
Biotech, healthcare, long only
Contributor since: 2012
Hadn't heard of class actions to recover short selling losses, but there is a lot of info out there on short selling around class action lawsuits, see http://bit.ly/1CWFIgA .
My opinion on most class action suits is it result ins pennies on the dollar after legal fees.
Exercise was in both arms.
Both arms of the Light trial had "Behavioral: Weight Management Program A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
Other Name: WeightMate (Tm)" form Clinicaltrials.gov
Its reasonable to speculate that contrave decreases cardiovascular risk, notably, in patients with high BMI and cardiovascular risk (enrollment criterion for the Light Trial).
Mechanism? Maybe , as you say, weight loss. Or is it something else. Contrave changes lipid markers in a favorable direction see http://seekingalpha.co... for a link to the briefing document.
Artisides Capital,
Stats aside, the trial needs to continue, look at the graph, don't you want to know whether longer term benefit changes, simply put, the lines may converge, diverge further, ... ?
Be nice to test whether there is cardiovascular benefit in patients with high BMI, but not the cardiovascular risk criteria of the light trial.
CER4040,
Both arms of the Light trial had "Behavioral: Weight Management Program
A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
Other Name: WeightMate (Tm)" form Clinicaltrials.gov
Its reasonable to speculate that contrave decreases cardiovascular risk, notably, in patients with high BMI and cardiovascular risk (enrollment criterion for the Light Trial).
Mechanism? Maybe , as you say, weight loss. Or is it something else. Contrave changes lipid markers in a favorable direction see http://seekingalpha.co... for a link to the briefing document.
Good find, thx. I think Mysimba will be approved, so the info you found tempers my buy enthusiasm only a little I suppose, admittedly, this whole space even after the approvals is speculative. It seems like one of these drugs should be a blockbuster eventually, but then again, obesity drugs usually are not. Some of the articles back in 2011 mentioned the poor sales of some of the drugs taken off the market.
1. There is more data on cardiovascular safety for Mysimba than belviq or Qsymia currently.
http://on.wsj.com/1uGfxlO
"Orexigen execs say they are unfazed. “It’s very clear that regulatory authorities are focused on long term cardiovascular outcome events,” Preston Klassen, an Orexigen senior vice president and head of development, told us last month when asked about the objections raised by Prescrire. “But this was a far larger data package that has ever been reviewed for safety and efficacy for an obesity drug.”"
2, BUT, Belviq or Qsymia are not approved in the EU.
Not sure about the putative bupropion / stimulant hypothesis and from the article apparently buproprion alone lowers risk.
"In a follow-up statement, he maintained that “there is extensive patient experience with bupropion in Europe across a number of clinical indications, including depression and smoking cessation. With respect to the latter indication, a comprehensive meta-analysis of clinical trials of smoking cessation therapies concluded that bupropion lowers the risk of major cardiovascular events among these patients.”"
3.
OK, not sure I buy your admittedly well-reasoned argument, but if insulin would take market share from GLP-1 agonists, hasn't it already mostly happened with injectable insulins? Why is inhalable, vs injectable, going to change a decision choice largely guided by the physicians?
Gaining market share from faster acting insulins, yes. Did not follow the logic for switching from GLP-1 agonists to inhalable insulin or any insulin for that matter. Different drug classes and MOA, different appearance in sequence of treatment progression, different adverse effects, etc., especially since a GLP-1 agonist is approved for obesity and insulin is associated with weight gain. The common denominator in the article seemed to be price"and injected vs inhalable, so switch? Not seeing that as a reason for switch, seems speculative at best?
Thanks for the response, it is always good to get first hand information.
Interesting, the draft solicitation is very brief on specs as you point out, there are many issues to be addressed. And there will be other layers of complexity that have nothing to do with the design of the gun, ammo choice / nato, where it is made, pricing of maintenance parts, which politicians find a way to benefit, I mean represent their constituents :) , ...
Acquisition?, interesting, been the opposite so far, Thompson center, etc.

printedit
"Those who cannot remember the past are condemned to repeat it"
George Santayana (1905) Reason in Common Sense, p. 284, volume 1 of The Life of Reason
sharinky, Just saying your insight that drugs to delay diabetes or knee replacement or whatever may be better than treating it later with drugs or surgery is interesting, I think Qsymia also decreased type 2 onset ( http://bit.ly/1pYRbms ), have not looked into Contrave. Many, myself included discuss the unknown cardiovascular risk or lack of risk that is being delineated now in trials, but we forget about the risk of not treating obesity. The FDA did take this into consideration, allowing Belviq and Qsymia on the market before adequate cardiovascular risk trials, BUT the drugs are only indicated for the higher risk obese patients (BMI over 30 and a risk factor).
Lance,
"One long-term investment strategy would be to invest in all of the pharmaceutical companies who have obesity drugs in their pipelines. This will probably produce a number of losers but possibly a spectacular winner."
and your losers will decrease the tax burden on your winner by your top tax rate.
A poster is on the internet on the Belviq phentermine pilot study.
http://bit.ly/1GSMkwf
sharinky, Interesting points. Metformin is associated with weight loss and delaying type 2 diabetes in prediabetic patients. 2 for 1?
Jonas500_,
for clarity for other readers, ETRM (stock symbol) is developing vagal nerve stimulation requiring a laparoscopic procedure for obesity treatment.

sbilhei,
Have to look into Contrave, interesting point on substituting generics.
Quick response on Qsymia, the doses of phentermine and topiramate are lower in Qsymia than the generic version pills, so it would be difficult to split the pills to achieve the proper dosing and the safety would be compromised if you just used generic two pill approach with higher doses.
Interesting on black box warning. Suicidal ideation increase in patients suffering depression resulted in blackbox warnings on most antidepressant drugs. Psychiatrists are looking for ideation when starting therapy with antidepressants, but there is a difference in the incidence of ideation and suicide. There is evidence that the blackbox warnings decreased prescriptions for at least adolescent patients with depression, and controversial whether that is good or resulted in under treatment of depression. Not really ready to predict (guess) how it will affect prescriptions for patients being treated for obesity, although depression and obesity are often comorbid.
Interesting point, anyone know if the actual Contrave clinical studies picked up an increase in suicidal ideation? This is a different patient population.
From the Contrave label;
"WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND
NEUROPSYCHIATRIC REACTIONS
See full prescribing information for complete boxed warning
 Increased risk of suicidal thinking and behavior in
children, adolescents, and young adults taking
antidepressants for major depressive disorder and other
psychiatric disorders. (5.1)
 Monitor for worsening and emergence of suicidal
thoughts and behaviors. (5.1)
 Serious neuropsychiatric events have been reported in
patients taking bupropion for smoking cessation. (5.2)
 CONTRAVE has not been studied in pediatric patients.
(5.1)"

Spencer,
Interesting on the AF reports. A lot of drugs are associated with AF.
http://bit.ly/1sy8Xvf
Would the current trial pick up a difference in incidence of AF between placebo and Belviq?
Do you think that is worrisome with regard to Arena valuation?
SP500ChartCom
Interesting point on drop out rates.
Isn't efficacy the reverse order; Contrave - Qsymia - Belviq ?
What es that foretell?
Jim, and more so for other investors that may not have followed the initial approval of Lorcaserin, the FDA required a post-marketing safety trial for Lorcaserin with MACE as the primary outcome.
http://bit.ly/MAt8bt
From Arena; "As part of the approval of BELVIQ, the companies committed to conduct post-marketing studies to assess the safety and efficacy of BELVIQ for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with BELVIQ on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments."
A trial is underway.
http://1.usa.gov/1sy0Vm1
from clinical trials.gov
"Primary Outcome Measures:
Time from randomization to first occurrence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
MACE events include: myocardial infarction, stroke and cardiovascular (CV) death
Time from randomization to conversion to type 2 diabetes mellitus (T2DM) for subjects without any type of diabetes at Baseline [ Time Frame: Baseline, and specified timepoints up to 5 years ] [ Designated as safety issue: No ]
Time from randomization to first occurrence of MACE+ [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
MACE+ events include: myocardial infarction, stroke, CV death, and hospitalization due to unstable angina, heart failure, or any coronary revascularization"
I repeat, cardiovascular risk for Belviq (at a level low enough to make benefit outweigh adverse effect) remains unknown --- and the trial is underway.
The small bel-Phen study / poster is in the article. A link to a photo of the poster of the small study of bel- Phen lacking any control groups ( no drug, bel, or Phen) is in the article for the reader's convenience and analysis. Emphasis seemed to be more on efficacy rather than safety in the study.
? Tramadol is a μ-opioid receptor agonist amongst other activities, however pain relief is only partially antagonized by naloxone (and presumably naltrzone). It's schedule IV, not "non-addictive". Agree on the contraindication obviously. The labeling includes tramadol in patients should be opiod free before starting Contrave.
Thx, but you shouldn't thank me for providing reinforcement, "all cause mortality", explain that concept to someone recovering from an MI.
WOSCOPS and AFCAPS/TexCAPS show reductions in MI and other coronary events in the primary prevention (mostly) on reduction in non-fatal events. Not to mention the Jupiter study, as published showing reductions in events (which you say was "fudged" and others hold a similar view discounting the study because it was halted early and other reasons). Non fatal MIs are an important outcome with regard to statins.
I can agree that Statin treatment should be stratified according to risk, but statins should not be excluded from primary prevention. The first link had some thoughts on CAC scans for risk stratification.
The other point being glossed over is the Jupiter study was in patients with normal cholesterol levels, and high c reactive protein levels, which is affirmation in a large clinical study that stains have multiple mechanisms of action in reducing risk.
here's another supporting your view, since I never quite got the convoluted subtraction argument the first time around that makes non-fatal MIs of little importance. This one takes the all cause mortality approach.
http://bit.ly/1wVUDB8
and one that brings up the debate well
http://bit.ly/1wVUDBb
I think it would be more accurate to say the NNT is higher for primary prevention and the ratio of NNT to NNH needs to be considered more carefully for primary than secondary prevention. And that is why a tool used to measure risk needs to be correlated with outcomes, and the study we started this discussion on is important.
Never?
Yes, the study shows that the new guidelines were a little better than the old in this patient population, which is a retrospective study of patient's getting angiograms. But meaningless? New vs old guidelines is a current controversial subject. And the last sentence excludes patients that don't meet the criteria for statin therapy.
But that doesn't negate the prevailing view that statin benefit outweighs diabetes risk for primary prevention, of course according to risk which is why I mentioned guidelines, and definitely for secondary prevention.
Most conclude statin benefits outweigh diabetes risk. http://bit.ly/1nG7ZBC. New study shows the accuracy of matching statins to atherosclerotic burden with new guidelines are even better, I thnk very impressive. http://bit.ly/1nG7ZBE
Maybe he meant "advertise", interesting though, atypical antipyschotics are definitely advertised on TV as adjunct therapy, but phentermine is more the adjunct drug here. Would "marketing" the use of the combination be wise if the company decides to develop a patentable single formulation?
Yes, labeling change, thank you.
You stated "If Eisai and Arena seek a labeling change, then the FDA may want another confirming study that does not have to be from a statistical standpoint any larger or longer than the current study."
I doubt it. As you state "You don't know at all if the FDA will require another study". True enough, but for approval of a labeling change, it is a safe bet the FDA would require a larger trial. Future trials should be powered to rule out an increase in a low frequency of adverse events, I would speculate that MACE would be the primary outcome and valvulopathy as a secondary outcome just like CAMELLIA-TIMI. The current phentermine/belviq trial is 225 subjects in 3 arms. From clinicaltrials.gov, the current safety trial for Belviq (CAMELLIA-TIMI) with MACE as the primary outcome is recruiting "Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1".
That's a 50 fold difference!
But on the flip side and in support of your position, the safety hurdle for approval of obesity drugs regarding cardiovascular risk was lower than the hurdle for current new diabetes drugs, at least for Arena and Vivus, not as much so for Orexigen.
Nothing to do with investing, but in the prescribing information, it states that patients may be more responsive to opiates immediately after stopping Contrave (presumably to take opiate pain meds), so lower opiate doses may be appropriate.
Yes, I meant to say thanks, Rod27. thank you healthythoughts.
worth considering, there is likely overlap in patient populations requiring chronic pain relief and candidates for obesity drugs, but how much?
Nice examples, overly restrictive labeling (liver function testing), which created the perception that these drugs may not have an excellent safety profile, may well have slowed the implementation of the most effective class of drugs for reducing risk from atherosclerosis. But Baycol (Cerivastatin) use, many cases involving co-administration with gemfibrozil, is attributed with 52 deaths. Caution on combination use, in retrospect, was warranted for fibrates, but probably not so much for Niacin. Niacin efficacy, well that became controversial recently as you note. Your comment "So go with the best information you have, make your best choice, and be prepared to change." addresses Niacin well indeed.
Your approach to informed consent, more when risk is unknown or greater, is commendable. You wrote "There's always informed consent. This is true with any medication. A little more informed consent for sure when you're waiting on the safety study on B+P. A discussion of risk and benefits always required. "
But clinical trials require informed consent in a fashion meeting standards and approved by an Institutional Review Board (IRB) for the explicit protection of human subjects. Prescribing drugs, informed consent is up to the prescribing physician, nurse practitioner, or Physician's assistant.
Prospective clinical trials are less likely to result in economically devastating lawsuits like other serious drug safety problems picked up in other ways.