· Concerns over cognitive tolerability profile are overblown and present opportunity to buy;
reiterate Market Outperform rating and $18 price target on VIVUS. We believe that the
concerns in the market yesterday related to the discontinuations from cognitive events in the Qnexa
Phase III trials are overblown and we remain confident that the safety and tolerability profile of
Qnexa is favorable. Furthermore, we are confident that the overall benefit-risk profile of all doses of
Qnexa provide a compelling argument for approval. Our $18 price target is derived by assigning a
30x multiple to our 2014 EPS projection of $1.67, discounted at 30% per year.
· Drop outs due to cognitive events do occur at a higher rate in full dose Qnexa than placebo
but this is expected, the rate is low, and we do not believe they will inhibit approval or
market potential. Cognitive adverse events are known side effects of topiramate and are reflected
on the current topiramate labels for epilepsy and migraine. In our view the key points to focus on
here are that 1) the rate of cognitive-related events, and discontinuations due to these events, is
expected to be higher than placebo based on the known side effect profile of topiramate, 2) the
event rate with Qnexa is low (less than 5% for any cognitive adverse event), 3) the vast majority of
these events are mild-to-moderate, and 4) when these events were not tolerated, and patients
discontinued, the effects were fully reversible.
· Cognitive tolerability may be improved in Qnexa compared with topiramate monotherapy.
The data released from both the EQUIP and CONQUER trials indicate that CNS and cognitive
adverse events occurred at rates below 5%, with exceptions of paresthesia, insomnia, and
dizziness. In Figure 1 we summarize the rates reported in the topiramate label from the migraine
trials and highlight those viewed by the FDA as dose-related. In EQUIP and CONQUER,
paresthesia was reported in 19% and 21% of patients on full-dose Qnexa (92mg topiramate/15mg
phentermine), respectively, compared with 50% of patients who received topiramate (100mg
monotherapy) in the migraine trials. The frequency of dizziness was also not greater with Qnexa
(6% and 10%) than reported in the migraine trials (9%). Insomnia rates were slightly higher in the
Qnexa trials (8% and 10% vs. 7%), however, insomnia is known to occur at higher rates in obese
people. We would highlight that cognitive events reported in the migraine label including language
The adverse events associated with discontinuing therapy in the topiramate-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%).
If 2.6% dropped out of Qnexa trial due to cognitive side effects, this is really not any lower than topiramate.
Is it possible that the combination is not all it's cracked up to be? That it really does not reduce side effects much compared to each drug alone? If so, this could be another "Alibra" like fiasco where investors had no idea that the combination of drugs used in Alibra were no better than each drug alone, until the FDA rejected Alibra outright. Vivus never released this information to investors back then. I sure hope they haven't made the same "mistake" again.
The most important part of the report was cut off at the end of your post. What were the rates of cognitive side effects in Qnexa trials? If over 2% dropped out due to cognitive side effects, there must be a much higher percentage of patients who experienced that side effect. I can read the Topamax label and get that information. What about Qnexa?
Adverse Event Placebo 50 100 200
Paresthesia 6 35 51 49
Fatigue 11 14 15 19
Nausea 8 9 13 14
Anorexia 6 9 15 14
Dizziness 10 8 9 12
Weight decrease 1 6 9 11
Difficulty with Memory NOS 2 7 7 11
Diarrhea 4 9 11 11
Concentration/Attention 2 3 6 10
Somnolence 5 8 7 10
Hypoaesthesia 2 6 7 8
Anxiety 3 4 5 6
Depression 4 3 4 6
Mood Problems 2 3 6 5
Dry Mouth 2 2 3 5
Confusion 2 2 3 4
Involuntary Muscle Contractions 1 2 2 4
Abnormal Vision <1 1 2 3
Renal Calculus 0 0 1 2
If you can read the label of any drug, it means it's an approved drug, on the market and being used. If any combination of two approved drugs carries no greater risk than the lone drugs, how does it make sense that the FDA would reject that drug out of hand?
if JPM so confident why don't they step in and buy several mil shares .
This is a hype to unload their shares when restriction is lifted .
poor investors who listened to JPM and bought in at $10.50 .
Sad part is these investors can Not sell their shares for 60 days
"if JPM so confident why don't they step in and buy several mil shares This is a hype to unload their shares when restriction is lifted ."
You are a poster who knows how this market works
Yes so they may be protecting their assest. Eventually they will lead the lawsuit claiming the CEO did not revel the data before the stock dilution and after insider sales including his. Lawsuits coming...