OCRX - I havent yet done DD here but I did talk with a liver specialist who looked at the results and said that the trial has a good chance of success. However he said there a few ammonia scavenging drugs on the market already, so it was unclear what advantages OC-002 has? Is it differentiated?

http://online.barrons.com/news/articles/SB51367578116875004693704580480132068866168?mod=yahoobarrons&ru=yahoo

ARRY selumetinib figures prominently in AZN slides today:


PIII Commenced Phase Est Filing US EU
selumetinib SELECT-1 2nd line KRAS+ NSCLC Q4 2013 2017 2017
selumetinib ASTRA differentiated thyroid Q3 2013 2017 2017
selumetinib SUMIT uveal melanoma Q2 2014 Q4 2015 Q4 2015

PII
selumetinib# 2nd line KRAS NSCLC Q1 2013

PI
AZD9291 +(MEDI4736# or selumetinib# or volitinib#)
EGFR tyrosine kinase inhibitor + (anti-PD-L1 or MEK inhibitor or MET yrosine kinase inhibitor)
advanced EGFRm NSCLC Q3 2014

ARRY- NVS presentation slides from yesterday still have MEK 162 and LGX818 as NVS pipeline drugs. They have
Mek162+LGX818 filing for BRAF mutant Melanome in 2016
Mek162 filling for NRAS mutant melanoma in 2016
Mek162 filling for LGSOC in 2016
And LGX818 filling for solid tumers 2019+
Thay said analysts are assuming closing in April

Sorry obviously meant arry not aria

Its funnny how aria might start creating value
After quite a few years of holding it - for totaly
Unexpected reasons. But thats usualy how
Things turn out in biotech...
Lokks like the nvs-glx deal far from hurting arry
Was the best thing that happend to them.
Mcbio i hope you still hold some- i have to thank
You (along with the former lehman analyst JB)
For quite a large position

Xoma is not a "well established company" - and neither are most research stage biotechs.
And, if you want to get exact about it - secondaries nowadays mostly refer to private equity... The term used to mean what you refer to as "follow on offering" a while back...

Many secondaries use warrants. Its either
That or give a big discount to the closing price - they
Priced it at yesterdays close. Everything considered
re Xomas recent lenghtning of the timeline I say
Again this could have been worse. To me it looks
Like they found willing investors.

The Xoma secondary terms looks pretty good to - warrants at about 60% higher for only two years. Looks like the market is pricing the warrants at 40-45 cents. Could have been much worse.
You can read from it that there are well educated investors willing to bet
Xoma is 60% higher in at most two years (although they maybe have already shorted the stock and gotten the warrants for free...

Pardon me, but shouldn't they be higher almost by definition? No new patients, longer times horizon, ergo additional AEs, ergo larger numbers...

AZN is actualy a very good fit for many reasons:
They have a huge push in cancer. They commited
To a large revenue growth rate in that area, and ARIA certainly
Reduces some of their pipeline risk.they have also said
In the past that they are looking at small-mid cap aquisitions.
And finally, they need quickly to spend some cash to
Put the PFE thing to rest.

AZN is additionaly showing:
Seq. AZD9291/selumetinib +
docetaxel/Iressa/CTLA-4 & PD-L1 Ph II NSCLC

ARRY - from AZN investor day pr:
"MEDI4736 is being studied in 12 combination trials, including ongoing Phase I development for a ‘triplet’ combination alongside BRAF and MEK inhibitors in melanoma, with results expected in the first half of 2015."

And this from their ESMO CC:

"And we did publish data at the (AACR) earlier this year showing that
we have looked for mechanisms of resistance that occur to 9291 and
seeing that we get MEK pathway activation in some preclinical models.
On the basis of these data, we have now initiated enrollment into a
study which is looking at the combination of 9291 plus our MEK
inhibitor, selumetinib, 9291 plus our MET inhibitor, volitinib, which has
shown activity in MET-amplified patients, and, of course, with PD-L1 in
this study.
So first subjects was dosed in the third quarter in all three
combinations. And, again, I look forward to updating you with data,
potentially ASCO next year, on the results of these studies. "

thanks Iwfal!, very interesting points. I like their straightforwardness and honesty. I am wondering whether I give them too much benefit of the doubt...
Although given the previous trial I find it hard to believe that Gev wont work in Bechets.

I thought the call went fine. They seemed cool and collected, and even HB was not very hypie. They seemed to be very business like - I liked it. My impression was they seemed to be holding back on things - for example Harvey gave the Japan deal as an example of how they want to do things - I thought that was a slip since they never really disclosed a Japan deal yet.

I started selling Aria when it reached 14 and sold out completely around 19. for a while there I was looking stupid. I had no information whatsoever about Pona AE's.
The reason was very simple - I looked at the risk/reward. I had a very large position bought at very low avg prices (remember the $1.75 financing in which HB bought 3 mil.) - so I had much more to lose if anything went wrong (all kind of things can go wrong in a biotech...) than I felt there was reasonale upside given a mktcap of almost 2 $Bil. (By the way this thinking dosent always work out for example INCY where I had a very large position and sold out at prices that now seem funny...)
As to my target now - that is not so simple:
(First of all I have already sold quite a bit in the run up to 9 - I have actualy been buying now in the 5s.). The risk/reward is heavily skewed to the upside (especialy given how negative things look now)
lately there have been biotechs with succesfull drugs that have reached close to 10 bil mktcaps - so I dont see Aria beeing constrained to 2 bil. However, things have to go right - Pona has to start growing big, and 113 has to get to the gate with a good profile. I believe this will happen, so I am comfortable sitting and waiting - without any clear timming in mind (which is why I am not using options on ARIA this time around).
Btwy, my take on the Harvey controversy is that it is all a side show. I remember when everybody hated him, then loved him, etc. In my opinion he
has proved to be a survivor - and in my experiance that is the most important quality in a CEO (I usualy lose money with quitters..)

I bought alot of shares during the recent crash
Couldnt resist the 2-4 stock price. Truth is I was
More lucky than smart selling out of a big positon
Pre-problem.
I do believe Aria is a very good bet here.

Actually, Analysts have very short memories... Just watch how they will be
all tripping over themselves to upgrade and talk highly of ARIA, once the stock price tide turns...

BR is busy covering. Or, Rather the hedge fund who employs
him at $0.5 a word is busy covering. Unfortunately, Volume is down lately
so it is going to be painful at some point

Thanks!
It says sept 12 on the draft is this final version?it says
The vote went 352:0 in favor- so looks final to me.
When did you see it? Why hasnt aria put out a pr?
I tried to read it ... Not very successfuly..
You have to compare it to the previuos annex

I wonder if this means Xoma are even more confident in the results of Eyegaurd B (i.e. they know the unscrubed results already) and are willing to go ahead and commit the money...

This is why:
http://finance.yahoo.com/news/ariad-presents-updated-clinical-data-113500877.html

aria 113 results from ESMO seem very very good to me. Anyone more qualified
care to opine?

http://finance.yahoo.com/news/ariad-presents-updated-clinical-data-113500877.html

ARRY from AZN PR today, notice anticipate first MEK Filling 2015:


selumetinib# SELECT-1
MEK inhibitor 2nd line KRAS+ NSCLC

Q4 2013 Ant. US file 2017 Ant. EU file2017

selumetinib# ASTRA
MEK inhibitor differentiated thyroid cancer

Q3 2013 Ant. US file 2017 Ant. EU file 2017

selumetinib# SUMIT
MEK inhibitor uveal melanoma

Q2 2014 Ant. US file 2015 Ant. EU file 2015

The Aria terms look very good to me as well
And the converts will probably end in good strong
Hands. I am kind of surprised the shares are falling
So much, maybe because the terms are complicated

Not that a 2020 list has any meaning...
Nonethless nice to see they have confidence
In Xoma's Gev ...

Aria pona in GIST - the results were not as feutile as some (here I think)
Speculated - 11 of 22 (50%) heavily pretreated paitents in the KIT exon 11 mutations group
Had a CBR

ARRY - actualy I think returning the MEK rights
To arry from nvs after a successful p3 is an enormus
Positive- there are still enough big onc organizations
That would love to market it and ARRY could negotiate
A very very good deal for an approved agent...
So i guess i dont see the downside in that, someone
Correct me if they think thats wrong

And here ARRY comments on the AZN/PFE Mek:
" So, let’s parse this a bit, in the AZ agreement if AstraZeneca is acquired by Pfizer it’s our belief that they will be able and entitled to assign rights and obligations on to Pfizer. Now I think all we can say about, we think that AZ and Pfizer are very, would be very interested in continuing to support this trial. I mentioned at the open that in the press release issued by Pfizer, they didn’t call out a whole lot, but they did call out KRAS-mutant disease as one of their rationales for being interested in AstraZeneca.

So we think there is a great deal of, there would be a great deal of natural interest in maintaining that plan. Of course uveal melanoma, which they are saying now would be finally in 2015 presumably would be unaffected and represent a quick path to market. And then there is a thyroid pivotal that is ongoing.

There are provisions related to diligent development and commercialization, but I really do believe that the interest of these companies either when -- either AZ on its own or as part of Pfizer would provide a tremendous motivation to move forward. And what's very impressive about the selumetinib program is that there are so many exploratory trials running with it, 52 trials in total over, almost three dozen that are Phase 2 or 3. And so, there is a lot of data that’s already been created or is in the process of being created to support forward plans for AZ and Pfizer."

from the ARRY CC regarding NVS GSK implications for the ARRY MEK:
"It is our expectation at this time that all clinical trials with binimetinib will continue to advance according to current development plan. In the event that Novartis’s binimetinib development and commercialization rights are in fact returning to Array. And Novartis must provide support for ongoing clinical studies as specified in our agreement.

Given a potential 2015 filing for NRAS melanoma, we believe that the possible return of all rights for binimetinib to Array could represent a substantial upside scenario and be transformative to our company and this of course would be an addition to our -- to the remainder of our robust portfolio."

This ARRY ASCO list was posted on Yahoo msg board by dcaf7: (If this is the full list, than I am surprised that not many Selumetinib papers are presented). Any comment welcome

MEK inhibitors from ARRY at ASCO 2014
Abstract #4090
ABC-04: A phase 1b trial of cisplatin, gemcitabine, and selumetinib in patients with advanced biliary tract cancer.
Abstract #2589
Phenformin combines with selumetinib in targeting KRAS mutant non-small cell lung cancer cells with alternative LKB1 status.
Abstract #10018
Phase I study of the MEK1/2 inhibitor selumetinib (AZD6244) hydrogen sulfate in children and young adults with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PNs).
Abstract #9051
A phase 1b dose-escalation study of BYL719 plus binimetinib (MEK162) in patients with selected advanced solid tumors.
Abstract #9009
A phase 1b/2 study of LEE011 in combination with binimetinib (MEK162) in patients with NRAS-mutant melanoma: Early encouraging clinical activity.
Abstract #TPS8122
A phase II cluster study of single agent AUY922, BYL719, INC280, LDK378, and MEK162 in Chinese patients with advanced non-small cell lung cancer (NSCLC).
Abstract #TPS9102
NEMO: A phase 3 trial of binimetinib (MEK162) versus dacarbazine in patients with untreated or progressed after first-line immunotherapy unresectable or metastatic NRAS-mutant cutaneous melanoma.
Abstract #TPS5618
The MEK Inhibitor in Low-Grade Serous Ovarian Cancer (??L?)/ENGOT-ov11 study: A multinational, randomized, open-label phase 3 study of binimetinib (MEK162) versus physician’s choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube, or primary peritoneum.

I was under the impression that MEK-162 is a "new & improved" MEK...
Any comparisons out there with the GSK MEK?

Thanks. Didn't think of that. ARRY should probably talk about
implications of the NVS GSK swap if any. Any other thoughts? competitive pressures or failures that are not self evident?

ARRY, is anybody aware of a particular reason
arry is weak? I would have thought withASCO
Coming up and news of the two MEKs it shouldnt
Be as weak. Any thoughts apreciated...

Dont know if this was posted already or lost in the shuffle but
GS increased their ARIA p/T to $6 and increased Iclusig peak sales estimate to $440mn vs. prior $350mn. They rased their M&A rank back to 2 from 3, btw they have a $14 M&A value.

One should distinguish between being an analyst
And being an investor. Analyst get paid based on how
Smart they sound, investors by how much money
They ACTUALY make... you hope a sell side analyst
Is well connected, talks to alot of people, etc. therefore
Is privy to more info than most. however the QUALITY of
The analysis of that information and the phsycolgical make up of the
Analyst isnt necesserly better then the avg joe.
And in most cases worse...

The reletivly new Barclays bio analyst who went from a 20 something target price on Aria to 2 overnight... does concede a slight positive:
"Slight positive for ARIA: The EMA's decision to allow Iclusig to remain on the market brings a sigh of relief for the company. However, the increased assessment and monitoring of patients recommended by the agency could weigh on physicians and may result in lower use of the product, in our opinion. We continue to believe that Iclusig will be mainly used for T315i mutation patients and as salvage therapy."

These are very vague statements... I wonder how much Tasinga's european revenues were last year (not to mention Gleevac).

Hoe did you arrive at that conclusion? Did you ever see any projection of EU sales for Pona?

If I recall correctly(and im not sure..) in EU you
Sometimes want to be second line because there are
Less pricing restrictions than first line. I am trying to recall the co
That made that argument several years ago.