Comments on: Pfizer’s failure provides clarity for Arqule http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/ Biotech stock reviews Sat, 19 May 2012 10:34:26 +0000 http://wordpress.org/?v=2.3.1 By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1666 Ohad Hammer Tue, 31 Aug 2010 12:46:23 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1666 Will answer that in tomorrow's article. Ohad Will answer that in tomorrow’s article.

Ohad

]]> By: sam http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1662 sam Mon, 30 Aug 2010 04:14:03 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1662 Imgn seems like dead money until results in 2012? Imgn seems like dead money until results in 2012?

]]> By: Jolly Rancher http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1660 Jolly Rancher Sun, 29 Aug 2010 14:33:17 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1660 sam, I don't want to clog Ohad's blog with too much off-topic posts, so you're welcome to email me at jolly_rancher36@yahoo.com. I don't have a lot of positions and nothing changes very often -- so I don't even use computers that much and check email about once or twice per week. Best regards. JR sam, I don’t want to clog Ohad’s blog with too much off-topic posts, so you’re welcome to email me at jolly_rancher36@yahoo.com. I don’t have a lot of positions and nothing changes very often — so I don’t even use computers that much and check email about once or twice per week. Best regards. JR

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1655 Ohad Hammer Sun, 29 Aug 2010 07:50:56 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1655 Will try to publish something on IMGN this week. Will try to publish something on IMGN this week.

]]> By: sam http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1654 sam Sat, 28 Aug 2010 22:10:50 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1654 You made some nice calls jolly rancher what other stocks do you own? thanks You made some nice calls jolly rancher what other stocks do you own?
thanks

]]> By: sam http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1651 sam Sat, 28 Aug 2010 06:01:17 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1651 hello ohad, what stocks are you personally long in the portfolio? In the seekingalpha article you disclosed that you were long arql, phizer, and incy (of course those were the only bio's mentioned in that article). thanks hello ohad,

what stocks are you personally long in the portfolio?

In the seekingalpha article you disclosed that you were long arql, phizer, and incy (of course those were the only bio’s mentioned in that article).

thanks

]]> By: Jolly Rancher http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1648 Jolly Rancher Fri, 27 Aug 2010 14:21:17 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1648 Hi Ohad, I bought IMGN this morning. Good cash position, having just issued 9M shares. The selloff is over done. JR Hi Ohad, I bought IMGN this morning. Good cash position, having just issued 9M shares. The selloff is over done. JR

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1647 Ohad Hammer Fri, 27 Aug 2010 12:53:35 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1647 In the short run -very bad news In the long run - no meaningful effect as the phase III trials are more important for T-DM1's commercial success. This rejection doesn't mean anything in terms of the value of IMGN's technology. Will try to publish something next week Ohad In the short run -very bad news
In the long run - no meaningful effect as the phase III trials are more important for T-DM1’s commercial success.

This rejection doesn’t mean anything in terms of the value of IMGN’s technology.

Will try to publish something next week

Ohad

]]> By: Dan http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1646 Dan Fri, 27 Aug 2010 11:35:44 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1646 Ohad, FDA just rejected fast track of TDM1...pushed back to mid 2012...what's your analysis on this announcement? Is there still promise in TDM1 and IMGN's guided missile technology? Thanks. Ohad, FDA just rejected fast track of TDM1…pushed back to mid 2012…what’s your analysis on this announcement? Is there still promise in TDM1 and IMGN’s guided missile technology? Thanks.

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1644 Ohad Hammer Thu, 26 Aug 2010 09:01:06 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1644 I am still following them but following the deal with AZN, I don't see a lot of important catalysts in the coming year or so. The rest of the pipeline is pretty early. Ohad I am still following them but following the deal with AZN, I don’t see a lot of important catalysts in the coming year or so. The rest of the pipeline is pretty early.

Ohad

]]> By: Seneo http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1643 Seneo Thu, 26 Aug 2010 08:34:04 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1643 No more interest for you in RIGL? No more interest for you in RIGL?

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1642 Ohad Hammer Thu, 26 Aug 2010 04:44:53 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1642 Toby, It is hard to say. I guess that they are seeing activity and a reasonable safety profile but their data is still early and limited (and unpublished). JAK looks like a great arena but don't forget there are plenty of active programs and companies like YM will probably have to face at least one established JAK inhibitor in the market. You now have Sanofi,Onyx and AZN in the race as well, so YM will have to differentiate their product. Ohad Toby,

It is hard to say. I guess that they are seeing activity and a reasonable safety profile but their data is still early and limited (and unpublished). JAK looks like a great arena but don’t forget there are plenty of active programs and companies like YM will probably have to face at least one established JAK inhibitor in the market.
You now have Sanofi,Onyx and AZN in the race as well, so YM will have to differentiate their product.

Ohad

]]> By: Toby http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1641 Toby Thu, 26 Aug 2010 04:34:06 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1641 Hello Ohad, you mentioned the JAK inhibitor of INCY. Have you an opinion to the JAK inhibitor CYT398 of YM BioSciences? They say their data is consistent with INCY's 18424, has an improved selectivity and a favorable side effect profil. Regards Toby Hello Ohad,

you mentioned the JAK inhibitor of INCY. Have you an opinion to the JAK inhibitor CYT398 of YM BioSciences? They say their data is consistent with INCY’s 18424, has an improved selectivity and a favorable side effect profil.

Regards Toby

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1640 Ohad Hammer Thu, 26 Aug 2010 04:32:34 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1640 The fact ARQ 197 generated such an OS signal is even more impressive given the fact 40% of the control arm crossed over to receive the combination. btw, a handful of crossover patients achieved actual tumor shrinkage, which is also a nice indication.I doubt the p3 trial will allow patients to cross over. Ohad The fact ARQ 197 generated such an OS signal is even more impressive given the fact 40% of the control arm crossed over to receive the combination. btw, a handful of crossover patients achieved actual tumor shrinkage, which is also a nice indication.I doubt the p3 trial will allow patients to cross over.

Ohad

]]> By: JQ http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1639 JQ Wed, 25 Aug 2010 17:48:06 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1639 Sutent trial didn't allow crossover from Traceva arm to Sutent+Tarceva arm as ARQ197 phase II did. Here is trial detail: http://clinicaltrials.gov/ct2/show/NCT00457392?term=sutent+tarceva&rank=4 Sutent trial didn’t allow crossover from Traceva arm to Sutent+Tarceva arm as ARQ197 phase II did. Here is trial detail:

http://clinicaltrials.gov/ct2/show/NCT00457392?term=sutent+tarceva&rank=4

]]> By: Ohad Hammer http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1637 Ohad Hammer Wed, 25 Aug 2010 06:00:06 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1637 Sorry JR, I don't follow CHTP. Looks liky they have an important binary event next month. Sam, I think you brough up a good point so I'll try to tackle it anyway. Yes, ARQ-197 did not meet the predefined primary endpoint but unlike the Sutent study, Arqule's phase II was not a registration trial and was intended to generate a signal. It indeed generated some interesting signals such as a stat sig improvement in non-squamous patients as well as an improvement in OS (which was just a trend). Even if you look at the entire population, factoring in imbalances which are validated wrt Tarceva response, the data looks positive. If ARQ-197 doesn't meet the primary endpoint in the phase III study which will hopefully be balanced and optimally designed then we can say the drug failed as well. Ohad Sorry JR, I don’t follow CHTP. Looks liky they have an important binary event next month.

Sam, I think you brough up a good point so I’ll try to tackle it anyway. Yes, ARQ-197 did not meet the predefined primary endpoint but unlike the Sutent study, Arqule’s phase II was not a registration trial and was intended to generate a signal. It indeed generated some interesting signals such as a stat sig improvement in non-squamous patients as well as an improvement in OS (which was just a trend). Even if you look at the entire population, factoring in imbalances which are validated wrt Tarceva response, the data looks positive.
If ARQ-197 doesn’t meet the primary endpoint in the phase III study which will hopefully be balanced and optimally designed then we can say the drug failed as well.

Ohad

]]> By: sam http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1636 sam Wed, 25 Aug 2010 01:38:32 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1636 too bad I cant delete my previous comment disregard it please. too bad I cant delete my previous comment
disregard it please.

]]> By: sam http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1635 sam Wed, 25 Aug 2010 01:36:53 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1635 sutent failed the primary endpoint of overall survival but passed the second endpoint of progression free survival. Didnt a similar thing happen to arq197? http://www.minyanville.com/businessmarkets/articles/cancer-non-small-cell-lung-cancer/8/24/2010/id/29779 sutent failed the primary endpoint of overall survival but passed the second endpoint of progression free survival.

Didnt a similar thing happen to arq197?

http://www.minyanville.com/businessmarkets/articles/cancer-non-small-cell-lung-cancer/8/24/2010/id/29779

]]> By: Jolly Rancher http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1634 Jolly Rancher Tue, 24 Aug 2010 19:39:52 +0000 http://www.hammerstockblog.com/pfizer%e2%80%99s-failure-provides-clarity-for-arqule/#comment-1634 Thank you so much for this. I bought a few chares of ARQL today. It's a bargain. Not to belabor the point, but have you checked out CHTP lately, which I mentioned a couple of times? I sold it at $4. Happy hunting. JR Thank you so much for this. I bought a few chares of ARQL today. It’s a bargain. Not to belabor the point, but have you checked out CHTP lately, which I mentioned a couple of times? I sold it at $4. Happy hunting.
JR

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