dakyne

Vivus: Obesity Experimental Drug Has Promising Outlook

Nice post Philly Dan. I'm astounded at what passes as (professional) analysis these days.

You touched upon the high points: the limited data points for the Qnexa clinical trials and the long exclusion criteria, relative to Lorcaserin's. There are reasons for this discrepancy: the adverse side effects of phentermine and topamax (both generic compounds, btw). Even if approved, and prescribed to a limited pool, the profit margin on Qnexa would be questionable.


On Jul 08 02:06 PM PhillyDan wrote:

> Only 756 patients in a 28 week study, not a significant study size.
> Exclusions for this study read like a medical dictionary. Weight
> loss results were achieved with highest dosage of both parts of the
> combo drug. Qnexa needs long term safety data like Lorcaserin has
> achieved with the two year Bloom study with over 3000 patients enrolled.
> They have the Sequel study which is an extension of the Conquer study
> to provide this data. Qnexa will not be ready for NDA until late
> 3rd quarter of 2010 and the earliest it could receive PDUFA is July
> or August 2011.
>
> Safety and tolerability will be more favorably viewed than weight
> loss efficacy by the FDA. Most Doctors don't like prescribing combo
> drugs because of the "unintended consequences from overlapping side
> effects". Phentermine raises concern with a number of MD's because
> it only can be prescribed for a certain amount of time, then needs
> to be stopped and restarted.
>
> In my opinion, Qnexa does have a lot of potential but still needs
> to prove itself in safety and tolerability. What the author conveniently
> forgot to mention is the dropout rate of patients in the Qnexa study
> which is quite high.
>
> The Blossom results for Lorcaserin will be announced in September.
> The Blossom study enrolled over 4000 patients at over 131 clinical
> centers around the United States. In addition, the Bloom-DM study
> will be completed soon and that study is tailored to patients with
> Type-II diabetes. Arena will file NDA in December with expected
> PDUFA in October of 2010. Arena has their own manufacturing facility
> in Switzerland that is ramped up and ready to go. That facility
> already does contract manufacturing for other drug companies.
>
> Recommend that you read about Ed Sussman's successful results on
> Medpage Today. Ed is a medical writer for MedPage who was overweight.
> He lost over 52 pounds (the likely assumption is that he was on Lorcaserin
> not the placebo) in 52 weeks. He was able to reduce both BP and
> Diabetes medications as a result of this weight loss.
>
> The obesity market is very large and will be able to handle more
> than one player to provide treatment for people suffering from the
> effects of being overweight or obese. What the author and other
> proponents of either Lorcaserin or Contrave forget to mention in
> their zealousness to promote the one they favor is the fact that
> people are all different. Some people may do better on Lorcaserin,
> others may do better on Qnexa or Contrave to help them lose weight
> and improve the other secondary endpoints. The main thing is that
> they are SAFE first and tolerable. Efficacy is important but should
> be the third thing that is considered in MD's recommending what to
> prescribe for their overweight and obese patients.
>
> I also strongly recommend you do your own due diligence if you wish
> to invest in any or all of these three companies. Based on your
> own due diligence and research, you will make an informed decision
> on which of the three (and there will be more, in fact Neuro Search
> is another company with a promising obesity drug candidate) is the
> best investment for you.

Arena Pharmaceuticals: Near Term Gamble May Be Worth It

After reading this thread and comments, I sure am glad I'm already long ARNA. Some of you are coming up with the right conclusion, but using flawed logic.

David, your instincts are correct--part of due diligence requires fundamental and subjective analysis of the scientific data. Looking at charts alone could steer you wrong.

Having said that, this is a binary event that could go either way. If you are long, you have to understand that with biotechs, the odds are against you, as most drugs fail clinical trials.

With ARNA, after some due diligence, the probabilities of success are higher than the average biotech, but it certainly is no guarantee.

Good luck to longs.