Comments on: Exelixis – Setting the Facts Straight http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/ Biotech stock reviews Sat, 19 May 2012 10:25:03 +0000 http://wordpress.org/?v=2.3.1 By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4430 Ohad Hammer Wed, 14 Dec 2011 01:08:15 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4430 A disaster... Ohad A disaster…

Ohad

]]> By: Mark http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4425 Mark Tue, 13 Dec 2011 17:07:25 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4425 Hammer, Any thoughts on the ECYT results today? Thanks, Mark Hammer,

Any thoughts on the ECYT results today?

Thanks, Mark

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4305 Ohad Hammer Sat, 26 Nov 2011 04:40:19 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4305 Don't have a clear answer there. It will eventually come down to differentiating MDV3100 from Zytiga based on OS difference and concomitant steroid usage. If you believe MDV3100 will be able to do so then the stock doesn't look overvalued (could be a $1.5-2B drug, 30% of that will go to MDVN based on a 50/50 profit split). Ohad Don’t have a clear answer there.
It will eventually come down to differentiating MDV3100 from Zytiga based on OS difference and concomitant steroid usage. If you believe MDV3100 will be able to do so then the stock doesn’t look overvalued (could be a $1.5-2B drug, 30% of that will go to MDVN based on a 50/50 profit split).

Ohad

]]> By: Ken http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4295 Ken Thu, 24 Nov 2011 12:35:39 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4295 Do you have any thoughts on Medivation? Do you believe it has become overvalued? Do you have any thoughts on Medivation? Do you believe it has become overvalued?

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4288 Ohad Hammer Wed, 23 Nov 2011 12:35:23 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4288 BP- sorry, not following them closely. Provocateur- The trial is very small but the data look strong enough to make you wonder about the role of the different Jaks in RA... Ohad BP- sorry, not following them closely.

Provocateur- The trial is very small but the data look strong enough to make you wonder about the role of the different Jaks in RA…

Ohad

]]> By: provocateur http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4282 provocateur Tue, 22 Nov 2011 21:15:52 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4282 You have never commented on the Galapogos JAK1 inhibitor. Do you see vale there? You have never commented on the Galapogos JAK1 inhibitor.
Do you see vale there?

]]> By: BP http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4281 BP Tue, 22 Nov 2011 18:07:18 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4281 Ohad: I appreciate all work insightful analysis. As long as you have looked at YMI, have you ever taken a look under the hood these 2 other Cand. biotechs IPCI & AEZS??? Thanks again for all your work. Eagle75 Ohad:
I appreciate all work insightful analysis. As long as you have looked at YMI, have you ever taken a look under the hood these 2 other Cand. biotechs IPCI & AEZS???
Thanks again for all your work.
Eagle75

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4277 Ohad Hammer Tue, 22 Nov 2011 10:18:22 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4277 provocateur - I think you need a long term randomized trial to capture the dynamic of anemia and transfusion dependence. In the meantime I will settle for longer follow up from multiple centers in the ongoing trial. Christian - It is hard to interpret these results although they do appear consistent and favorable compared to gistoric controls. The originally intended to to a randomized p2 but there was this hypersensitivity reaction that enabled patients and physicians to know who got placebo or the drug. Hopefully, this issue was dealt with in the current protocol. Ohad provocateur - I think you need a long term randomized trial to capture the dynamic of anemia and transfusion dependence. In the meantime I will settle for longer follow up from multiple centers in the ongoing trial.

Christian -
It is hard to interpret these results although they do appear consistent and favorable compared to gistoric controls. The originally intended to to a randomized p2 but there was this hypersensitivity reaction that enabled patients and physicians to know who got placebo or the drug. Hopefully, this issue was dealt with in the current protocol.

Ohad

]]> By: Christian http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4273 Christian Mon, 21 Nov 2011 22:05:25 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4273 hi Ohad, http://ir.celldextherapeutics.com/phoenix.zhtml?c=93243&p=irol-newsArticle&ID=1632411&highlight= what do you think about these results published by CLDX? does the median PFS for ACTIII with 12,3 (compared to 15,3 and 14,2 for ACTI and II) seem suspicious? by the way, what is the main reason that CLDX did not conduct the PII-trials with a real control group but only with historical control? is that because of costs, or....? I guess this is the main reason why the market does not think that this program is worth a lot. thanks! Christian hi Ohad,

http://ir.celldextherapeutics.com/phoenix.zhtml?c=93243&p=irol-newsArticle&ID=1632411&highlight=

what do you think about these results published by CLDX? does the median PFS for ACTIII with 12,3 (compared to 15,3 and 14,2 for ACTI and II) seem suspicious?

by the way, what is the main reason that CLDX did not conduct the PII-trials with a real control group but only with historical control? is that because of costs, or….? I guess this is the main reason why the market does not think that this program is worth a lot.

thanks!
Christian

]]> By: provocateur http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4261 provocateur Sat, 19 Nov 2011 22:20:20 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4261 Ohad When will the validation come?Do you have an idea? Also is there any other lab doing this other than Dr. Tefferi? Ohad

When will the validation come?Do you have an idea?
Also is there any other lab doing this other than Dr. Tefferi?

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4260 Ohad Hammer Sat, 19 Nov 2011 21:44:09 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4260 Even if YMI's drug is comparable to Jakafi in efficacy it still has value as a fast follower. Jak inhibitors address markets far larger than myelofibrosis. Ohad Even if YMI’s drug is comparable to Jakafi in efficacy it still has value as a fast follower. Jak inhibitors address markets far larger than myelofibrosis.

Ohad

]]> By: provocateur http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4259 provocateur Sat, 19 Nov 2011 19:14:30 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4259 My 2 cents on Jakafi: The differences in the Anemia responses at one time were attributed to the differences in Activity over the JAK 3 of the 4 Jak family.This information was available on YMI website before but the storyline on the differences has moved to now a mutant In the JAK family.I like a passionate doctor but Dr Tefferi has been 'too' passionate..the proof of this is what I consider a hit peice in the form of a letter in NEJM before Jakafi's approval(this gets interesting as Dr Tefferi was at one time in one of Incyte's trials before moving to YMI's CYT387).The conflicts of interest/revenge at work?Also I will be comfortable if CYT387'S results are duplicated in another lab(its all now from Dr Tefferi's lab) but we might have to wait for that until Phase 3.I am not alleging anything but it is certainly interesting.The point I am trying to make is YMI is a 'trading' stock whule Incyte stands on its own. My 2 cents on Jakafi:
The differences in the Anemia responses at one time were attributed to the differences in Activity over the JAK 3 of the 4 Jak family.This information was available on YMI website before but the storyline on the differences has moved to now a mutant In the JAK family.I like a passionate doctor but Dr Tefferi has been ‘too’ passionate..the proof of this is what I consider a hit peice in the form of a letter in NEJM before Jakafi’s approval(this gets interesting as Dr Tefferi was at one time in one of Incyte’s trials before moving to YMI’s CYT387).The conflicts of interest/revenge at work?Also I will be comfortable if CYT387′S results are duplicated in another lab(its all now from Dr Tefferi’s lab) but we might have to wait for that until Phase 3.I am not alleging anything but it is certainly interesting.The point I am trying to make is YMI is a ‘trading’ stock whule Incyte stands on its own.

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4245 Ohad Hammer Fri, 18 Nov 2011 05:43:35 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4245 Jakafi doesn't improve anemia in MF patients and can lead to anemia in some whereas YMI's drug is claimed to resolve anemia. Both are Jak inhibitors (with some limited differences) and I am not aware of a good explanation for this difference. The data from YMI is intriguing but it is still preliminary and not validated. Ohad Jakafi doesn’t improve anemia in MF patients and can lead to anemia in some whereas YMI’s drug is claimed to resolve anemia. Both are Jak inhibitors (with some limited differences) and I am not aware of a good explanation for this difference. The data from YMI is intriguing but it is still preliminary and not validated.

Ohad

]]> By: Mark http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4243 Mark Fri, 18 Nov 2011 00:47:40 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4243 Ohad, Do you have any feel for why YMI's drug would not exhibit the same anemia effects as Jakafi? It seems strange that they target the same target/pathway yet have different anemia profiles. Do you find the depth of data YMI has presented so far convincing? Mark Ohad,

Do you have any feel for why YMI’s drug would not exhibit the same anemia effects as Jakafi? It seems strange that they target the same target/pathway yet have different anemia profiles. Do you find the depth of data YMI has presented so far convincing?

Mark

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4238 Ohad Hammer Thu, 17 Nov 2011 09:14:32 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4238 1. It's old news, Synta already stated they expect to re-partner some of the CRACM assets in the coming months. 2. The main question is the alleged anemia effect of YMI's drug . If proven, it could be a worthy opponent to Jakafi. Ohad 1. It’s old news, Synta already stated they expect to re-partner some of the CRACM assets in the coming months.

2. The main question is the alleged anemia effect of YMI’s drug . If proven, it could be a worthy opponent to Jakafi.

Ohad

]]> By: Chris http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4237 Chris Thu, 17 Nov 2011 09:04:02 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4237 Hi Ohad, 1. In your opinion how would Roche termination of collaboration of "CRACM" will affect SNTA? 2. what do you think of YMI after FDA approval of INCY Myelofibrosis drug? can you comment on If YMI drug also approved in the future, what is the potential for the stock? Thanks Chris Hi Ohad,

1. In your opinion how would Roche termination of collaboration of “CRACM” will affect SNTA?
2. what do you think of YMI after FDA approval of INCY Myelofibrosis drug? can you comment on If YMI drug also approved in the future, what is the potential for the stock?
Thanks
Chris

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4223 Ohad Hammer Tue, 15 Nov 2011 17:10:18 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4223 yeah. It was an interesting call. The selumatinib trial was initiated with PFS as a primary endpoint and along the way AZN changed it to overall survival, which is a little bit unreaslistic for an 80 patient study. The most important thing right now is getting a glimpse of the data and see the PFS difference which was stat significant. Couldn't understand from the call whether the PFS difference was clinically meaningful, though. They're gonna have data for the p38 and ksp programs at ASH. Ohad yeah. It was an interesting call.

The selumatinib trial was initiated with PFS as a primary endpoint and along the way AZN changed it to overall survival, which is a little bit unreaslistic for an 80 patient study. The most important thing right now is getting a glimpse of the data and see the PFS difference which was stat significant. Couldn’t understand from the call whether the PFS difference was clinically meaningful, though.
They’re gonna have data for the p38 and ksp programs at ASH.

Ohad

]]> By: Christian http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4207 Christian Mon, 14 Nov 2011 18:07:15 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4207 Hi Ohad, have you already had the chance to talk to ARRY mgmt? Thanks! Hi Ohad,

have you already had the chance to talk to ARRY mgmt? Thanks!

]]> By: Ohad Hammer http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4189 Ohad Hammer Sun, 13 Nov 2011 02:56:30 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4189 Looks goods, no doubt. Hard to predict how the market will react to that, as it was clear both studies would have encouraging results. Ohad Looks goods, no doubt. Hard to predict how the market will react to that, as it was clear both studies would have encouraging results.

Ohad

]]> By: provocateur http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4182 provocateur Sat, 12 Nov 2011 18:29:53 +0000 http://www.hammerstockblog.com/exelixis-%e2%80%93-setting-the-facts-straight/#comment-4182 Just reviewed the abstracts at AACR: Looks very impressive!This looks like a miracle drug tome active across multiple doses.An approval at MTC can provoke off label expansions. Just reviewed the abstracts at AACR:
Looks very impressive!This looks like a miracle drug tome
active across multiple doses.An approval at MTC can provoke off label expansions.

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