Comments on: 5 Winners of ASH 2011 http://www.hammerstockblog.com/5-winners-of-ash-2011/ Biotech stock reviews Sat, 19 May 2012 10:13:33 +0000 http://wordpress.org/?v=2.3.1 By: bellweather http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5124 bellweather Mon, 26 Mar 2012 20:22:59 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5124 Although it's true that generic Gleevec will be available by the time ponatinib(P) is approved first line, it's also true that the body of scientific thought appears to be favoring the use of "best drugs" first, in order to avoid/minimize the development of mutational strains of disease that are more difficult to treat by any means and are more disposed to relapse. Amazingly, so far, no cml mutations to P have occurred, and even if they ultimately do, the order of magnitude of these is likely to be small. Therefore,in addition to the intent to avoid the development of mutations, I believe it's likely(regardless of economic concerns) that P will be the favored first line treatment on approval(particularly for new cases of advanced and blast phase disease), because it's superiority of outcome will be apparent, in such cases, due to long-term data derived from ongoing Phase II and Phase III studies. When you combine this with it's preferred use in all resistant and intolerant cases of a patient population, the prevalance of which continues to grow WW due to dramatically increased survival, P's commerical viabilility(in cml alone)begins to look much more substantial than a face value read suggests. Then, of course, we haven't even begun to discuss P's potential efficacy in solid tumors, and a entire range of other mutational forms of disease, both as mono and combination therapy(see AACR): http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=86650fd2-9bf9-4582-bbf5-0d0c334be4d1&cKey=a6b15caa-9370-4b9f-8ea7-2849b5a582cf&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=1b6c7da6-cd89-44c1-8b8b-2c41067efb90&cKey=dddc6455-cd59-432c-b40d-351d8a42edd6&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d Nor have we even touched on AP26113(Ariad's dual ALK/EGFR inhibitor) which, IMO, has appropriately created a lot of buzz(See AACR Abstract): http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=fb913a97-5c2f-4ae9-a31c-308b356663ff&cKey=4cc676b9-ec16-475d-94f1-161f3127ff23&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d I think all one really needs to know about the perceived quality Ariad's scientific and commerical program was demonstrated by the institutional market response to the recent disappointing FDA review committee evaluation of the joint MRK/Ariad MTor inhibitor(ridaforolimus)- After a very brief and rapid selloff, Ariad ended up about 4% on the day on huge volume. I hope you'll excuse my enthusiasm here, seeing as it's by far my largest position. Best regards, bw Although it’s true that generic Gleevec will be available by the time ponatinib(P) is approved first line,

it’s also true that the body of scientific thought appears to be favoring the use of “best drugs” first, in order to avoid/minimize the development of mutational strains of disease that are more difficult to treat by any means and are more disposed to relapse.

Amazingly, so far, no cml mutations to P have occurred, and even if they ultimately do, the order of magnitude of these is likely to be small.

Therefore,in addition to the intent to avoid the development of mutations, I believe it’s likely(regardless of economic concerns) that P will be the favored first line treatment on approval(particularly for new cases of advanced and blast phase disease), because it’s superiority of outcome will be apparent, in such cases, due to long-term data derived from ongoing Phase II and Phase III studies.

When you combine this with it’s preferred use in all resistant and intolerant cases of a patient population, the prevalance of which continues to grow WW due to dramatically increased survival, P’s commerical viabilility(in cml alone)begins to look much more substantial than a face value read suggests.

Then, of course, we haven’t even begun to discuss P’s potential efficacy in solid tumors, and a entire range of other mutational forms of disease, both as mono and combination therapy(see AACR):

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=86650fd2-9bf9-4582-bbf5-0d0c334be4d1&cKey=a6b15caa-9370-4b9f-8ea7-2849b5a582cf&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=1b6c7da6-cd89-44c1-8b8b-2c41067efb90&cKey=dddc6455-cd59-432c-b40d-351d8a42edd6&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d

Nor have we even touched on AP26113(Ariad’s dual ALK/EGFR inhibitor) which, IMO, has appropriately created a lot of buzz(See AACR Abstract):

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=fb913a97-5c2f-4ae9-a31c-308b356663ff&cKey=4cc676b9-ec16-475d-94f1-161f3127ff23&mKey=%7b2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7d

I think all one really needs to know about the perceived quality Ariad’s scientific and commerical program was demonstrated by the institutional market response to the recent disappointing FDA review committee evaluation of the joint MRK/Ariad MTor inhibitor(ridaforolimus)-

After a very brief and rapid selloff, Ariad ended up about 4% on the day on huge volume.

I hope you’ll excuse my enthusiasm here, seeing as it’s by far my largest position.

Best regards,

bw

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5123 Ohad Hammer Mon, 26 Mar 2012 07:22:51 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5123 Thanks. They are progressing very nicely, still, the read out from a 1st line study is several years away. In the meanwhile, a lot depends on the label they receive for the accelerated approval. Also, don't forget Gleevec will be generic by the time ponatinib receives 1st line approval. Ohad Thanks.
They are progressing very nicely, still, the read out from a 1st line study is several years away. In the meanwhile, a lot depends on the label they receive for the accelerated approval.

Also, don’t forget Gleevec will be generic by the time ponatinib receives 1st line approval.

Ohad

]]> By: bellweather http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5120 bellweather Sun, 25 Mar 2012 18:28:30 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-5120 Hi Ohad, Appreciate the blog, but as of the 3-6-12 Cowen conference(page25): http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MTI5NjAyfENoaWxkSUQ9LTF8VHlwZT0z&t=1 Ariad's head to head trial of ponatinib vs Gleevec is scheduled to begin in Qtr3 2012, not next year. Since the results of this trial are essentially guaranteed to be favorable, this materially increases Ariad's current market valuation relative to the previous expectation. Thought you'd want to know. Best regards, bw Hi Ohad,

Appreciate the blog, but as of the 3-6-12 Cowen conference(page25):

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MTI5NjAyfENoaWxkSUQ9LTF8VHlwZT0z&t=1

Ariad’s head to head trial of ponatinib vs Gleevec is scheduled to begin in Qtr3 2012, not next year.

Since the results of this trial are essentially guaranteed to be favorable, this materially increases Ariad’s current market valuation relative to the previous expectation.

Thought you’d want to know.

Best regards,

bw

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4684 Ohad Hammer Mon, 16 Jan 2012 22:24:09 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4684 wednesday wednesday

]]> By: provocateur http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4683 provocateur Mon, 16 Jan 2012 17:22:50 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4683 Did you get to talk to the CEO of Synta ? Did you get to talk to the CEO of Synta ?

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4646 Ohad Hammer Tue, 10 Jan 2012 16:31:41 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4646 Not likely in my opinion. They would have waited with the financing if they had something to tell. Ohad Not likely in my opinion. They would have waited with the financing if they had something to tell.

Ohad

]]> By: provocateur http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4644 provocateur Tue, 10 Jan 2012 13:18:14 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4644 I have an inkling that something is going to be announced tomorrow.Its too much of a coincidence that the financing closes tomorrow and Synta presents a poster tomorrow of gpib in KRAS tumors. I have an inkling that something is going to be announced tomorrow.Its too much of a coincidence that the financing closes tomorrow and Synta presents a poster tomorrow of gpib in KRAS tumors.

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4622 Ohad Hammer Sat, 07 Jan 2012 19:26:11 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4622 Those are good questions I have no answers to. I saw that presentation that implicitly talks about a Gpib deal in Q1. Will talk with the CEO next week and try to see if anything changed. Ohad Those are good questions I have no answers to. I saw that presentation that implicitly talks about a Gpib deal in Q1.
Will talk with the CEO next week and try to see if anything changed.

Ohad

]]> By: provocateur http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4620 provocateur Sat, 07 Jan 2012 14:39:24 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4620 Usually you get an upfront payment,however small.So it did not even amount to 28 million.Maybe, they like you are still waiting on a larger set of data.So, the deal is really off. I just went to their Jan ppt on their website.It still talks of a partnership.Why continue that line...? Usually you get an upfront payment,however small.So it did not
even amount to 28 million.Maybe, they like you are still waiting on a larger set of data.So, the deal is really off.
I just went to their Jan ppt on their website.It still talks of a partnership.Why continue that line…?

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4618 Ohad Hammer Sat, 07 Jan 2012 05:09:37 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4618 Bear in mind the deal SNTA have been talking about is sale of Asian rights, which shouldn't come with any financial commitment from their end. Therefore, the offering should be viewed as a negative imo. Ohad Bear in mind the deal SNTA have been talking about is sale of Asian rights, which shouldn’t come with any financial commitment from their end. Therefore, the offering should be viewed as a negative imo.

Ohad

]]> By: provocateur http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4613 provocateur Thu, 05 Jan 2012 23:39:42 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4613 Ganetespib has a long road with more flushing out of the genetic profiles needed.I think the deal is done but there might be Synta obligations in the deal which require funding.I am an investor and maybe its coloring my objectivity Ganetespib has a long road with more flushing out of the genetic profiles needed.I think the deal is done but
there might be Synta obligations in the deal which require funding.I am an investor and maybe its coloring my objectivity

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4612 Ohad Hammer Thu, 05 Jan 2012 22:10:35 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4612 David- yep CRIS has done very well over the last year, there is no particular reason for not writing about it. Re CYT387, I agree but YMI must prove the anemia effect is there in a randomized trial. Sam- I think ganetespib is far better than elesclomol because it is active as a single agent and has at least 2-3 good biomarkers for patient selection. Today's news might imply the company could not get the terms it was hoping for. Ohad David- yep CRIS has done very well over the last year, there is no particular reason for not writing about it.
Re CYT387, I agree but YMI must prove the anemia effect is there in a randomized trial.

Sam- I think ganetespib is far better than elesclomol because it is active as a single agent and has at least 2-3 good biomarkers for patient selection. Today’s news might imply the company could not get the terms it was hoping for.

Ohad

]]> By: sam http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4606 sam Wed, 04 Jan 2012 13:50:09 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4606 It appears that maybe skepticism about g-pib may be what is delaying a partnership with synta if and when the results are released (just a guess). It appears that you believe (as many others)that it will be difficult for g-pib to show a benefit. I remember you felt that it would be difficult for eleschomol to show a benefit in the past and you analysis turned out to be correct...do you feel g-pib has a better chance of positive results than eleschomol did? However, there appears to be some smart money opening positions in synta such as RA Management and QVT Financial. It appears that maybe skepticism about g-pib may be what is delaying a partnership with synta if and when the results are released (just a guess). It appears that you believe (as many others)that it will be difficult for g-pib to show a benefit. I remember you felt that it would be difficult for eleschomol to show a benefit in the past and you analysis turned out to be correct…do you feel g-pib has a better chance of positive results than eleschomol did? However, there appears to be some smart money opening positions in synta such as RA Management and QVT Financial.

]]> By: David http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4597 David Tue, 03 Jan 2012 18:54:08 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4597 Ohad Why no mention of your top performing pick, CURIS, its has more than doubled? Also, oncologists will prescribe CYT387 if it works, and won't care if the company can't explain the science behind its effectiveness, Ohad

Why no mention of your top performing pick, CURIS, its has more than doubled?

Also, oncologists will prescribe CYT387 if it works, and won’t care if the company can’t explain the science behind its effectiveness,

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4590 Ohad Hammer Mon, 02 Jan 2012 23:20:14 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4590 Thanks, Sam. No doubt, people are expecting a significant deal in Asia during the coming months. The lung cancer trial should also have PFS readout, it's not going to be easy to show a benefit over taxotere in the general population imo. Subpopulation data could be interesting, though. Ohad Thanks, Sam. No doubt, people are expecting a significant deal in Asia during the coming months. The lung cancer trial should also have PFS readout, it’s not going to be easy to show a benefit over taxotere in the general population imo. Subpopulation data could be interesting, though.

Ohad

]]> By: sam http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4585 sam Mon, 02 Jan 2012 04:32:57 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4585 Thank you Ohad Hammer...your unbiased opinions are always appreciated. Your articles and opinions have always been interesting along with the opinions of others. 2012 will be an exciting year for synta with a partnership or lack there of, lung cancer results that if positive or negative will set the tone for other other cancers being treated. I may being puts just in case something unexpected happens with g-pib. Sam Thank you Ohad Hammer…your unbiased opinions are always appreciated. Your articles and opinions have always been interesting along with the opinions of others. 2012 will be an exciting year for synta with a partnership or lack there of, lung cancer results that if positive or negative will set the tone for other other cancers being treated. I may being puts just in case something unexpected happens with g-pib.
Sam

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4582 Ohad Hammer Sat, 31 Dec 2011 07:47:10 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4582 Basically an approval for BCC is baked in, with a lot of variability in sales projections. I personally think the market as will appear in the label will be quite small but I saw some reports with much richer projections. Expansion to locally advanced disease /BCNS could be the driver here even though safety will play a bigger role (p2 data update in BCNS next year). Other catalysts are - NDA for oral version of CUDC101 and the PI3K/HDAC. To me the most intriguing asset is Debio932, which is supposed to have data at ASCO and a decision by Debiopharm to to start p2 in 1H12. Hsp90 inhibitors are one of most exciting areas imo. Ohad Basically an approval for BCC is baked in, with a lot of variability in sales projections. I personally think the market as will appear in the label will be quite small but I saw some reports with much richer projections. Expansion to locally advanced disease /BCNS could be the driver here even though safety will play a bigger role (p2 data update in BCNS next year).

Other catalysts are - NDA for oral version of CUDC101 and the PI3K/HDAC.
To me the most intriguing asset is Debio932, which is supposed to have data at ASCO and a decision by Debiopharm to to start p2 in 1H12. Hsp90 inhibitors are one of most exciting areas imo.

Ohad

]]> By: sam http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4581 sam Fri, 30 Dec 2011 23:23:14 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4581 Curis has been up sharply in 2011 with an NDA in March 2012. Can you update us on Curis? Thanks. Curis has been up sharply in 2011 with an NDA in March 2012. Can you update us on Curis? Thanks.

]]> By: Ohad Hammer http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4549 Ohad Hammer Sun, 25 Dec 2011 07:14:58 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4549 Thanks , have a great year. Ohad Thanks , have a great year. Ohad

]]> By: Dan http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4548 Dan Sat, 24 Dec 2011 22:40:24 +0000 http://www.hammerstockblog.com/5-winners-of-ash-2011/#comment-4548 Dear Ohad, thanks for your time, effort, and insights via this blog. Merry Christmas and may peace and joy abound you and your family in 2012. Dear Ohad, thanks for your time, effort, and insights via this blog. Merry Christmas and may peace and joy abound you and your family in 2012.

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