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Not true. How do you think we get to $55-60M in sales by year end? I say one patient at a time. You have to assume total Q1 pts. at 1.5 months average treatment and so 200 pts. yields $3M.
And so 3+10+18+29 = $60M
But don't take my word for it, use Mike King's $56M then.
No question. I'm counting on $36 YE '13.
Here's how.
$24 by Feb 8th - 1st Qtr. Earnings Call
Iclusig Update - launch, attrition of compassionate use/expanded access, sales force
'113 Update MTD, DLT, and recommended dose for PH2 cohorts
Announce timing for 5th molecule IND
$28 by May 8th - 2nd Qtr Earnings Call
Report Q1 Iclusig sales of $3-5M
ASCO abstracts for '113 (3 mos. PH2 results as late-breaking)
Early Iclusig data for GIST and SCC
Half of EPIC trial pts. enrolled (starts clock on 12 mos. readout)
$32 by Aug 8th - 3rd Qtr Earnings Call
Report Q2 Iclusig sales of $10-12M
Half of EPIC trial pts. enrolled (starts clock on 12 mos. readout)
EMA approval of Iclusig (sales not expected until '14)
Initiate PH1 trial of 5th molecule
$36 by YE'13
ESMO - 6 mos. '113 PH2 data for all cohorts
EPIC trial at ASH(3 mos. comparison of safety/tolerability vs. Imatinib)
P.S. Bob's your uncle...
Exercising now means 12 months from now he has the option to sell as a long-term capital gain, so he's seeing upside between now and mid '14. The sell would be a 2014 tax event.
New Hope for Rida?
Seems only current Phase 2 trial is for breast cancer. This article suggests potential in GI.
Hop to it Merck.
http://www.wehi.edu.au/site/latest_news/potential_new_treatment_for_gastrointestinal_cancers_discovered
Iclusig will bring in revenues of $56M in 2013...
Here's how:
1Q $3M (approx. 200 new pts. for 1.5 mos. avg.)
2Q $9M (addl. 250 new pts. 1.5 mos. plus 1Q pts. for 3 addl. mos.)
3Q $17M (addl. 300 new pts. for 1.5 mos. plus 1-2Q pts. for addl. 3 mos.)
4Q $26M (addl. 350 new pts. for 1.5 mos. plus 1-3Q pts. for addl. 3 mos.)
Total $56M with 1100 pts. rolling into 2014.
Do the math...in 2014 if we hold rate of prior pts. plus 25 each qtr. then 2014 ends with $146M total revenue.
But of course second half 2014 should include addl. $$$ for first line and Europe.
Listen to Rachel Minn's question at 36:15...
She gets it. Listen to her question and Haluska's response at 36:15 on the conf. call. She asks a leading question about the data for T315i patients demonstrating much fewer AE's in less heavily pre-treated patients, suggesting front-line use will have more favorable safety profile.
I'm sure Scott Matusow will clarify sales of Icluelis...
I think Rachel Minn's question at 36:15 is key. Essentially she highlights the data for T315i patients as less heavily pre-treated and Frank confirms these patients have much fewer AE's. This suggests front-line use will have more favorable safety profile.
Will we see ASH news Sunday?
Before the 4:30PM PACE 12-month data update?
Can someone explain benefit of orphan drug status?
I mean if dasatinib, nilotinib, bosutinib, and very soon ponatinib all have orphan drug status in US and EU for CML then what is the benefit? Can there really be 7 years of market exclusivity in US and 10 years in EU for four relatively new drugs for the same indication?
Or is orphan drug status just a tax benefit?
Thanks.
Ponatinib 'Best of the Bunch' in Ph-Positive Leukemia?
I like the title of this article about the NEJM publication:
http://www.medscape.com/viewarticle/775207
Curious how this ASH abstract finding resistant mutations with Ponatinib was funded by Novartis and Bristol-Myers Squibb.
https://ash.confex.com/ash/2012/webprogram/Paper47619.html
Abstract #2436 A Niche-Based Cell Mutagenesis Assay Identifies ABL-Kinase Mutations Appearing in BCR-ABL T315I-Mutated Leukemic Cells Treated with Ponatinib
"In conclusion, our assay shows that the hematopoietic stem cell niche could play a crucial role in conferring resistance to Ponatinib, not only via the occurrence of novel mutations but also by providing survival signals. Preliminary results also suggest that the hematopoietic niche could facilitate the emergence of T315I mutation in cells expressing native BCR-ABL. These results could be important to study the mechanisms of the occurrence and selection of ABL-K mutations in patients treated with TKI including Ponatinib, and to develop niche-targeted therapies to overcome TKI-resistance in CML.
Disclosures: Turhan: Novartis, Bristol Myers Squibb: Honoraria, Research Funding."
Timmy C. on the trumpet...
I agree...its time to unpack Pona...
I expect all of the below on Friday:
1. Next indication for Pona with pre-clinical data (FLT-3?)
2. Status of several expected IST trials
3. Announcement that 12-month PACE data will be presented at ASH 2012 in December
4. Status of enrollment of EPIC trial
5. Status of Merck Rida trials (several have completed and new ones started without a peep)
6. Status of dose escalation on '113 - it has been 28 days since 240mg started.
And...wait for it....
7. Announcement of IND for 5th novel, internally discovered drug candidate!!
[Warning! Seems like we are going to need some more $$$.]
Jan '15 calls? Who's with me?
Jan 2015 options start trading tomorrow...get them while they're cheap.
Good luck to all.
Oldie but goodie...
New article on importance of NFKB's role in lung cancer.
Any chance the new molecule inhibits NFKB? Or maybe at least there's still life in those old patents, after USPTO called infield fly rule on them.
http://www.wiley.com/WileyCDA/PressRelease/pressReleaseId-105477.html
New patent awarded on Oct 2...
A little help? Is our new compound inhibiting the Src/ VEGFR pathway? Or is this broader protection for pona?
"The compounds of this invention have a broad range of useful biological and pharmacological activities, permitting their use in pharmaceutical compositions and methods for treating metabolic disorders, bone diseases (e.g., osteoporosis, Paget's Disease, etc.), inflammation (including rheumatoid arthritis, among other inflammatory disorders) and cancer (including solid tumors and leukemias, especially those mediated by one or more kinases such as Src or kdr, or by dysregulation of a kinase such as Abl and mutant variants thereof), including, among others, advanced cases and cases which are resistant or refractory to one or more other treatments. "
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=ariad.ASNM.&OS=AN/ariad&RS=AN/ariad
This is all by HB design. Now the FDA clock starts with 45 days to announce priority review, which I predict will only take 30 days. At which point we will be "launch ready", just in case approval is pre-Thanksgiving. I still believe HB intentionally delayed filing this "minor technical data" to avoid early FDA approval prior to launch ready date of end of October.
I maintain a by Turkey-day approval.
Gobble gobble.
Article referenced stresses FGFRs as targets...
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature11404.html
Just a friendly reminder about Pona and FGFR...
http://mct.aacrjournals.org/content/11/3/690.short?rss=1
Pop Quiz: Who co-founded ARIA, VRTX, & INFI?
Answer: Stuart Schreiber
Good genes lead to good things...
Re: next molecule, I like the way HB put it on recent earnings call....
The next molecule is progressing "very, VERY well" to IND.
Timmy C. added a little more flavor yesterday at Stifel Nicolaus, something like...next molecule will be a TKI targeting established pathway and its resistant mutations.
Don't you agree HB delayed the "complete" NDA on purpose...
Why would he file 99.5% and wait weeks to file "routine CMC data"? We have been preparing "minor, routine, technical" parts of the application for almost a year now.
I think HB intentionally delayed a complete filing to ensure our launch ready date of October 31st happens prior to early approval.
And so why would we be launch ready on October 31st only to carry those expenses for several months into mid-Q1'13?
Because....a mid-September complete filing starts FDA 45-day clock to receive Priority Review by end of October followed by early approval by Thanksgiving.
Gobble gobble...
Didn't see this new potential for Pona posted here...
Haematologica. 2012 Aug 8. [Epub ahead of print]
Ponatinib as targeted therapy for FGFR1 fusions associated with the 8p11 myeloproliferative syndrome.
Chase A, Bryant C, Score J, Cross NC.
Source
University of Southampton, UK.
Abstract
The 8p11 myeloproliferative syndrome is a rare, aggressive myeloproliferative neoplasm characterised by constitutively active FGFR1 fusion proteins that arise from specific chromosomal translocations and which drive aberrant proliferation. Although FGFR1 inhibitors have shown in vitro activity against FGFR1 fusions, none are in use clinically and there is a need to assess additional compounds as potential therapy. Here we use cell lines and primary cells to investigate ponatinib (AP24534). Ponatinib-treated Ba/F3 cells transformed by ZMYM2-FGFR1 and BCR-FGFR1 and the FGFR1OP2-FGFR1 positive KG1A cell line showed reduced proliferation and decreased survival when compared to control cells. Inhibition induced apoptosis and reduced phosphorylation of the FGFR1 fusion proteins and substrates. Ponatinib-treated cells from five 8p11 myeloproliferative syndrome patients showed reduced colony growth compared to controls. In one evaluable patient, ponatinib specifically reduced numbers of FGFR1-fusion gene positive colonies. Ponatinib therefore shows considerable promise for the treatment of patients with 8p11 myeloproliferative syndrome.
HB delayed the "complete" NDA on purpose...
Why would we file 99.5% and wait weeks to file "routine CMC data"? Haven't we been preparing the "minor, routine, technical" parts of application for almost a year now. Either it was incorrect and needs to be re-submitted OR...
HB intentionally delayed a complete filing to ensure our launch ready date of October 31st happens prior to early approval.
Also why would we be launch ready on October 31st only to carry those expenses for several months into mid-Q1'13?
Pona is already Fast Track and will no doubt get Priority Review status by mid-September. Remember there are NO available treatments on market for CML patients with T315I mutuation.
In summary I think we can expect approval by early December.
I prefer HB's version of patient population...
125,000 patients globally for EGFR (50% resistant due to T790M mutation out of 250,000 total)
50,000 patients globally for ALK (5% of NSCLC, small increase in occurence from 4%)
10,000 patients for ROS (1% of NSCLC)
Total potential global patient population = 185,000
'113 Market Share
I assume 30% T790M EGFR (30% Erlotinib, 30% Dacomitinib, 10% Other)
I assume 45% of market in ALK (25% Crizotinib, 30% LDK378, 10% Other)
I assume 30% ROS (30% Crizotinib, 40% Other)
Total market share of global patients for 113 = 37,500 EGFR + 22,500 ALK + 3,000 ROS = 63,000
63,000 patients x $100,000/ year = $6.3B for '113 in 2021
'113...not too shabby....
Ever notice how CML is tip of the iceberg...
Types of Hematological Malignancies
1. Leukemias 30.4%
Acute lymphoblastic leukemia (ALL) 4.0%
Acute myelogenous leukemia (AML) 8.7%
Chronic lymphocytic leukemia (CLL) 10.2%
Chronic myelogenous leukemia (CML) 3.7%
Acute monocytic leukemia (AMOL) 0.7%
Other leukemias 3.1%
2. Lymphomas 55.6%
Hodgkin's lymphomas 7.0%
Non-Hodgkin's lymphomas 48.6%
3. Myelomas 14.0%
Post removed. No harm intended, thought good news publicly re-posted on an independent blogsite was fair.
New abstract on pona combo with chemos...
http://www.ncbi.nlm.nih.gov/pubmed/22778153
That was me, at least half of them. Just adding to my collection of Jan'14 25's. And yes, I'm predicting $43 PPS by then. I've grown quite fond of 800% gains at the LTCG tax rate.
GLTAL.
Balanced view on 2nd & 3rd gen TKI's in CML...
insert-text-here
Good article on pona's next indication...AML
http://www.sciencedaily.com/releases/2012/04/120415150128.htm
Digging new "social stream" view on Nasdaq.com
Fast aggregator of all feeds and comments on Ariad, or any ticker you may prefer.
New Patent on Jan. 31...
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=ariad&s2=ariad&OS=ariad+AND+ariad&RS=ariad+AND+ariad
Patent Number 8,106,191
Looks Rida related...anyone?
26113 potential for breast cancer...
I like what I see in this article from AACR-EROTC as potential for 26113.
Signaling Pathway Linked to Inflammatory Breast Cancer May Drive Disease Metastasis
http://www.aacr.org/home/public--media/aacr-press-releases.aspx?d=2536
Leaps and bounds todays friends...
2013 and 2014 leaps to start trading.
Good luck.
Here's my list for the rest of 2011:
1. Interim PH2 for Pona at ASH
2. New indication PH3 trial for Rida (Endometrial or combo)
3. New indication PH2 trial for Pona (ALL)
4. Ex-US deal for Pona