pharmaman

Vivus: A One Trick Pony

Seems as though there is room for more than 1 drug in the huge obesity business. However, the question is good -- how do these drugs compare on efficacy -- is there too wide a gap?

When will the data from the second Arena trial become available -- I thought they had said end September with NDA filing by end December?

A Biotech Triple Play: Dendreon, BioCryst and Arena

Why is Arna buling up on equity at $4 if its price will go up when good results become available in September?

Vivus: Obesity Experimental Drug Has Promising Outlook

Hey PhillyDan,

What do you think are the shortcomings of Lorcaserin -- do you have an analysis on that?

Pharmaman


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.

Vivus: Obesity Experimental Drug Has Promising Outlook

Hey PhillyDan,
Yours is a well considered, analytical response.
Why could the author of this article not have done his homework?
Your analysis makes the author if this article look like a dilettante merely interested in getting an article on the web. I would like to hear his response.

Pharmaman


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.

Adult Stem Cell Drugs and Therapies Are the Next Big Market

There is gold in them thar hills !!!!
Yes - but when will it surface??????

On Jun 20 11:20 AM cytxcell wrote:

> Among all who are digging for gold in goldmines everywhere, which
> one would you bet your money on? Don't know about you, I'll bet on
> the only one who is selling picks and shovels to everyone to dig...
> and that one is Thermogenesis(seekingalpha.com/symbo...),
> no real competition and it'll be the 1st stem cell related companies
> to become profitable.
>
> KOOL's management guided fy 2010 to become profitable and fy 2010
> starts July 01, 2009 less than 10 days away and i won't be surprised
> if they are profitable from 1st quarter(july-sep, 2009) on.

Arena Pharmaceuticals: Near Term Gamble May Be Worth It

Now that you have seen the data from the Bloom Trial, what is the view of the experts about approvability by the FDA and also about the comparison with the competition -- Vivus and Orexigen?