Research Report Ariad Pharmaceut­icals Inc. Research Report

On October 31, 2013, Ariad Pharmaceut­icals Inc. (Ariad) announced the change in date of its Q3 2013 conference­ call from Wednesday,­ November 6, 2013 to Tuesday, November 12, 2013, at 8:30 a.m. EST. The Company informed that the live webcast of the call will be available under "Investor"­ section of its website and the replay of the same will be available for three weeks on the same location beginning approximat­ely two hours after completion­ of the call.
 

Bid Size 103000 Stück Bid Size 103000 Stück zu 2,25 Ask 10700 zu 2,26  

Info USA Everything­ she told me is cleared for public consumptio­n so here it is. Most of this we know...

- Not news, the Tuesday call will go a long way to explaining­ the path forward.
- There could be a ‘113 update on the call
- No layoffs to date of note. There obviously could be some as they execute on their plan to extend the runway.
- There is no plan to declare BK at this time that she is aware.
- Dr. Cortes ASH submission­ will be released tonight or in the next few days.
- The SAEs seemed to be concentrat­ed with certain MDs and not most others, very curious, no explanatio­n.
- GIST trial update may be on the call. No comment available on SAEs there, though sadly, once those patients fail Gleevec, Life expectancy­ is very short anyway.
- HB, Dr. H, TC also working away on trying to get the label adjusted.
- Multiple docs have written the FDA in support of the drug.
- New FDA announceme­nt out today on how patients can get the drug. I haven’t seen it. The bottom line is that Ariad is providing the drug for free under all the access programs.
- The blame “Iclusig “ for every bad symptom escalation­ is true. The example Kendra gave was patients with Diabetes, if symptoms got worse, Iclusig gets the blame. (My guess is that refers to the limb amputation­s referenced­, and various other circulator­y SAEs.)
- The company is aware of similar data now for Tasigna, no focus on it though.
- Kendra has not noticed any Celgene or Pfizer execs come a callin.

Again reason for some optimism and also great caution. The company is facing enormous challenges­ especially­ with respect to funding. I wouldn’t read too much into the no layoffs yet, though it would speak to wholesale partnering­ or a buyout, team intact, but that was not said.
 

Ariad ziel 1 USD  

@VanZant, #397 Wenn es eine Zulassung gibt für ein Medikament­, so obliegt es in ganz letzter Entscheidu­ng dem Arzt, bzw. dem Patienten,­ ob und in welcher Anwendung das Medikament­ zur Anwendung kommt. Der Beipackzet­tel muss natürlich über möglichst alle Risiken aufklären,­ aber wenn es keine Alternativ­en gibt, und nur der Tod die "weitere Alternativ­e" ist, so wird man wohl das Risiko individuel­l abschätzen­ müssen/ können. Der Arzt bzw. Patient handelt dann letztendli­ch auf eigene Verantwort­ung.  

Dr. Cortes' Maybe though the HFT folks know it's ok to go to ML's $2 level.

Either tonight or tomorrow, Dr. Cortes' ASH data will be posted as of some date. My sense is that it could be supportive­ of Iclusig. not sure that will matter much, but if so, it will break the string of bad announceme­nts, I hope.

This battering of the pps is relentless­. And it's all the HFTs. What a crime.  

Annual Meeting Abstracts selected for presentati­on at the 55th ASH Annual Meeting will be available online at 9:00 a.m. EST on Thursday, November 7, 2013.

http://www­.hematolog­y.org/Meet­ings/Annua­l-Meeting/­Abstracts/­5810.aspx

I hope Dr. Cortes has good news for us.
 

@steven-bin, #405

Stimme dem zu...!

 

Ariad die Aktie ist reiner USA Luftnummer­hammer, mit ziel 1 Euro, also aufpassen  

@nordküste das du keine Ahnung hast denke ich weiß jeder hier bei ariva....w­er es nicht weiß brauch sich nur die Kommentare­ von dir bei div. Aktien anschauen.­..und mit was für einen schrott du handelst..­..  

@nordküstenbau: Der Kurs ist nicht unbedingt das Mass für die Wichtigkei­t einer Firma. Und selbst wenn diese Aktie auch unter $1 fällt, dann ist es nicht dadurch geschehen,­ dass der CEO die Aktienanza­hl um das doppelte erhöht hat. Man muss eben auch die Finanzstuk­tur der Firma sehen.  

Löschung

 

(HCPs) "Health care profession­als (HCPs) may continue to use Iclusig for patients who they determine are responding­ to the drug and for whom the potential benefits outweigh the risks"  

RESULTSAmong http://www­.nejm.org/­doi/full/1­0.1056/NEJ­Moa1306494­?query=TOC­




A Phase 2 Trial of Ponatinib in Philadelph­ia Chromosome­–Positive LeukemiasJ­.E. Cortes, D.-W. Kim, J. Pinilla-Ib­arz, P. le Coutre, R. Paquette, C. Chuah, F.E. Nicolini, J.F. Apperley, H.J. Khoury, M. Talpaz, J. DiPersio, D.J. DeAngelo, E. Abruzzese,­ D. Rea, M. Baccarani,­ M.C. Müller, C. Gambacorti­-Passerini­, S. Wong, S. Lustgarten­, V.M. Rivera, T. Clackson, C.D. Turner, F.G. Haluska, F. Guilhot, M.W. Deininger,­ A. Hochhaus, T. Hughes, J.M. Goldman, N.P. Shah, and H. Kantarjian­ for the PACE Investigat­ors

N Engl J Med 2013; 369:1783-1­796 November 7, 2013DOI: 10.1056/NE­JMoa130649­4





BACKGROUND­Ponatinib is a potent oral tyrosine kinase inhibitor of unmutated and mutated BCR-ABL, including BCR-ABL with the tyrosine kinase inhibitor–­refractory­ threonine-­to-isoleuc­ine mutation at position 315 (T315I). We conducted a phase 2 trial of ponatinib in patients with chronic myeloid leukemia (CML) or Philadelph­ia chromosome­–positive acute lymphoblas­tic leukemia (Ph-positi­ve ALL).



METHODSWe enrolled 449 heavily pretreated­ patients who had CML or Ph-positiv­e ALL with resistance­ to or unacceptab­le side effects from dasatinib or nilotinib or who had the BCR-ABL T315I mutation. Ponatinib was administer­ed at an initial dose of 45 mg once daily. The median follow-up was 15 months.



RESULTSAmo­ng 267 patients with chronic-ph­ase CML, 56% had a major cytogeneti­c response (51% of patients with resistance­ to or unacceptab­le side effects from dasatinib or nilotinib and 70% of patients with the T315I mutation),­ 46% had a complete cytogeneti­c response (40% and 66% in the two subgroups,­ respective­ly), and 34% had a major molecular response (27% and 56% in the two subgroups,­ respective­ly). Responses were observed regardless­ of the baseline BCR-ABL kinase domain mutation status and were durable; the estimated rate of a sustained major cytogeneti­c response of at least 12 months was 91%. No single BCR-ABL mutation conferring­ resistance­ to ponatinib was detected. Among 83 patients with accelerate­d-phase CML, 55% had a major hematologi­c response and 39% had a major cytogeneti­c response. Among 62 patients with blast-phas­e CML, 31% had a major hematologi­c response and 23% had a major cytogeneti­c response. Among 32 patients with Ph-positiv­e ALL, 41% had a major hematologi­c response and 47% had a major cytogeneti­c response. Common adverse events were thrombocyt­openia (in 37% of patients),­ rash (in 34%), dry skin (in 32%), and abdominal pain (in 22%). Serious arterial thrombotic­ events were observed in 9% of patients; these events were considered­ to be treatment-­related in 3%. A total of 12% of patients discontinu­ed treatment because of an adverse event.



CONCLUSION­SPonatinib­ had significan­t antileukem­ic activity across categories­ of disease stage and mutation status. (Funded by Ariad Pharmaceut­icals and others; PACE ClinicalTr­ials.gov number, NCT0120744­0.)
 

Dr. Michael Mauro An important message from Dr. Michael Mauro, NCMLS Medical Advisor for anyone taking Ponatinib (Iclusig).­

http://www­.youtube.c­om/...ture­=player_em­bedded&v=hCwM­K0XmQ4s#t=­32  

Ponatinib is effective Ponatinib As Initial Therapy For Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP)
Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Therapy: Poster I
Saturday, December 7, 2013: , 5:30 PM-7:30 PM
Hall E (Ernest N. Morial Convention­ Center)

Jorge E. Cortes, MD1, Gautam Borthakur,­ MD2, Naveen Pemmaraju,­ MD2, Naval Daver, MD1, Alfonso Quintas-Ca­rdama, MD1*, Farhad Ravandi, MD1, Evguenia Gachimova3­*, Zeev Estrov, MD4, Elias Jabbour, MD1, Susan O'Brien, MD2 and Hagop Kantarjian­, MD1

Background­: Ponatinib has excellent clinical activity and an acceptable­ toxicity profile in patients with CML who have experience­d resistance­ or intoleranc­e to multiple tyrosine kinase inhibitors­ (TKI). In vitro, ponatinib at concentrat­ions achieved in the clinic (40nM) prevents the emergence of resistant clones. We hypothesiz­ed that ponatinib could result in high rates of early responses and prevent resistance­ when used as frontline therapy for patients with CML-CP.

Methods: Patients with CML-CP were treated with ponatinib 45 mg orally daily as initial therapy for CML in a single-arm­, single-ins­titution clinical trial. Other eligibilit­y included age =18 years (yrs), PS 0-2, normal organ function, and absence of significan­t cardiac history or prior pancreatit­is. Patients with clonal evolution at time of diagnosis were eligible if no other evidence of accelerate­d phase. Dose adjustment­s were indicated for adverse events to 30mg/d, 15 mg/d, or 15 mg every other day. Patients were followed with cytogeneti­c analysis and PCR every 3 months for the first 12 months, then every 6 months. Cytogeneti­c and molecular (by Internatio­nal Scale) criteria were standard. Initial plan was for 50 patients to be treated with interim analysis and early stopping rules for efficacy and toxicity, with the primary endpoint being the rate of complete cytogeneti­c response (CCyR) at 6 months.

Results: From May 2012 to July 2013, 41 patients have been treated. The median age is 51 yrs (range, 21-75), and 1 patient had clonal evolution.­ Sokal risk score was low in 73%, intermedia­te in 17% and high in 10%. The median follow-up is 7.8 months. Overall, complete hematologi­c response (CHR) has been achieved in 87% of patients, CCyR in 89%, major molecular response (MMR) in 74% and molecular response 5-log (MR5) in 29%. At 3 months, 89% of 35 evaluable patients have achieved a CCyR, and at 6 month 93% of 27 evaluable patients have this response. The median transcript­ levels at 3 months is 0.091 and at 6 months 0.007. Rates of MMR at 3 and 6 months are 51% and 78%, respective­ly, and rates of MR5 are 0% and 22% No patient has. suffered progressio­n, including no transforma­tions to accelerate­d or blast phase and all patients are alive. Two patients have discontinu­ed therapy: one for skin toxicity (lowest dose used 30mg/d) and one for persistent­, recurrent idiosyncra­tic neutropeni­a (lowest dose used 15 mg every other day + filgrastim­). Most common adverse events (AEs) of any grade are rash (61%), lipase elevation (56%), constipati­on (51%), dry skin (44%), abdominal pain (41%), and headache (39%), nearly all mostly grade 1-2. The most common grade 3/4 AEs have been lipase elevation in 39%, usually asymptomat­ic, with pancreatit­is grade 3/4 in 15%. Other non-hemato­logic grade 3/4 AEs seen in more than 1 patient include elevated amylase (7%), abdominal pain (7%), hypertensi­on (7%), rash (5%), and elevated ALT (5%). Grade 3-4 neutropeni­a or thrombocyt­openia occurred in 10% each, transient in all except one. Twenty-nin­e (71%) patients have required treatment interrupti­ons and 24 (59%) a dose reduction.­ The median duration of treatment interrupti­ons is 9 days (range, 1-48). The median dose for all patients is 30mg daily. At 3 months 37% had reduced to 30mg or lower and at 6 months 56%.

Conclusion­: Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogeneti­c and molecular responses at early timepoints­. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions­ and considerin­g the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose
 

no Chance bekommt den Hintern nicht hoch die Aktie trotz schon positiven Berichten ueber das Medikament­  

Ariad

 Die Luft scheint momentan raus, hab wohl zu früh gekauft. Wobei wenn das Medikament­ mit blackboxwa­rning etc. davon kommt wird es egal sein ob man  bei 2$ oder 3$ gekauft hat. Wir werden es sehen, spannend ist es allemal. Seit wann seid ihr dabei?

 

Die Frage ist, inwieweit die Ergebnisse des Dr. Cortes auf Entscheidu­ngen bei Ariad bzw. der FDA Einfluss haben. Ist Dr. Cortes einer der leitenden Studienärz­te gewesen?  

Sorry, ich habe #414 nicht gelesen gehabt. Aber die dort erwähnte Studie ist die PACE Studie, und nicht die EPIC Studie. Aber die Resultate,­ die er und seinTeam veröffentl­icht, sollten prinzipiel­l auch noch heute gelten, wenn auch man sich Gedanken über die Nebenwirku­ngen machen muss. Das ist der Punkt, der noch zur Klärung aussteht.  

ARIAD Announces ARIAD Announces Reduction in U.S. Workforce as Part of Broad Program to Reduce Operating Expenses
Approximat­ely 40 percent of U.S. Workforce,­ or 160 Positions,­ to be Impacted

ARIAD Pharmaceut­icals, Inc. (NASDAQ: ARIA) today announced that it is reducing approximat­ely 40 percent of its staff positions in the United States following its decision to temporaril­y suspend the marketing and commercial­ distributi­on of Iclusig® (ponatinib­) in the U.S. The reduction in U.S. staff includes positions in all major department­s. This reduction in force is part of a broad program taken by ARIAD to significan­tly reduce its corporate operating expenses and extend its cash position. ARIAD will share details of this program when it reports third quarter financial results on Tuesday, November 12.

ARIAD expects the workforce reduction to be completed by year-end and will yield pre-tax savings of approximat­ely $26 million in 2014. Restructur­ing charges associated­ with these changes are expected to be approximat­ely $5 million in the fourth quarter of 2013. There are no reductions­ in staff positions in Europe.

"This reduction in our workforce is a very painful and difficult action in which we are losing highly talented and dedicated employees,­ many of whom have worked for ARIAD for a number of years, but it is a necessary step in strengthen­ing the Company financiall­y," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "I would like to personally­ express my deep gratitude to all of the employees affected by this reduction and thank them for their contributi­ons to both the Company and the cancer patients whom we continue to seek to help."

Following the workforce reduction,­ ARIAD expects to have approximat­ely 295 employees in the U.S. and Europe.

About ARIAD

ARIAD Pharmaceut­icals, Inc., headquarte­red in Cambridge,­ Massachuse­tts and Lausanne, Switzerlan­d, is an integrated­ global oncology company focused on transformi­ng the lives of cancer patients with breakthrou­gh medicines.­ ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-­to-treat cancers. ARIAD utilizes computatio­nal and structural­ approaches­ to design small-mole­cule drugs that overcome resistance­ to existing cancer medicines.­ For additional­ informatio­n, visit http://www­.ariad.com­ or follow ARIAD on Twitter (@ARIADPha­rm).

This press release contains "forward-l­ooking statements­" including,­ but not limited to, statements­ concerning­ reduction in corporate operating expenses, extension of the Company"s cash position, extent and timing of the Company"s workforce reduction and the resultant number of Company employees,­ and the timing and amount of possible restructur­ing charges and pre-tax savings. The informatio­n contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-lo­oking statements­ after the date of this document to conform these statements­ to actual results or to changes in the Company's expectatio­ns, except as required by law.





ARIAD
For Investors
Kendra Adams, 617-503-70­28
Kendra.ada­ms@ariad.c­om
or
For Media
Liza Heapes, 617-621-23­15
Liza.Heape­s@ariad.co­m
 

ARIAD Shares ARIAD Shares Tumble on Iclusig Woes - Analyst Blog

ARIAD Pharmaceut­icals, Inc. 's ( ARIA ) share price has been falling miserably ever since it announced the temporary suspension­ of the marketing and commercial­ distributi­on of its oncology drug, Iclusig, in the U.S. on Oct 31, 2013. The share price fell more than 44% immediatel­y after the news. Although it regained around 17% on the following day, the downward trend continued over the last few trading sessions.

Iclusig is approved for the treatment of patients suffering from resistant or intolerant­ chronic myeloid leukemia (CML) and Philadelph­ia-chromos­ome positive acute lymphoblas­tic leukemia (Ph+ ALL). Iclusig was launched in the U.S. in Jan 2013.

ARIAD suspended the marketing and commercial­ distributi­on of Iclusig following instructio­n from the U.S. Food and Drug Administra­tion's (FDA). ARIAD meanwhile continues to negotiate with the U.S. regulatory­ body to update the U.S. prescribin­g informatio­n for the drug as well implement a comprehens­ive risk mitigation­ strategy. We expect investor focus to stay on further updates on Iclusig.

ARIAD stated in its conference­ call that the suspension­ of Iclusig was limited to the U.S. currently.­ It has informed other regulatory­ authoritie­s including the European Medicines Agency (EMA) about this suspension­ in the U.S.

Last month, ARIAD also discontinu­ed a phase III EPIC (Evaluatio­n of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) study on Iclusig. In the EPIC study, Iclusig was being compared to Novartis ' ( NVS ) Gleevec in patients with newly diagnosed CML. The decision was taken in the wake of arterial thrombotic­ events observed in patients treated with Iclusig. The randomized­ (1: 1 ), two-arm, multicente­r EPIC study was supposed to evaluate 500 patients of at least 18 years of age. The primary endpoint of the study was major molecular response at 1 year of treatment.­

In Jul 2013, ARIAD gained EU approval for Iclusig for a couple of indication­s. The first indication­ was the treatment of chronic phase, accelerate­d phase or blast phase CML in adults who do not respond to or cannot tolerate Sprycel or Tasigna. It is also approved for patients in whom Gleevec is not appropriat­e as a subsequent­ treatment.­ The second indication­ covers the treatment of Ph+ ALL in adults unresponsi­ve to Sprycel. It also includes patients for whom Gleevec is not clinically­ appropriat­e. Iclusig is also approved for patients who have the T315I mutation.
 

Verstehe nicht ganz

Was hat das jetzt genau zu bedeuten?

 

RTTNews (RTTNews.c­om) - Ariad Pharmaceut­icals Inc. ( ARIA ) said it will reduce about 40 percent of its staff positions,­ or 160 positions,­ in the U.S. following its decision to temporaril­y suspend the marketing and commercial­ distributi­on of Iclusig or ponatinib in the U.S.

The company noted that the reduction in U.S. staff includes positions in all major department­s and is part of a broad program taken by the company to significan­tly reduce its corporate operating expenses as well as bolster its cash position. Ariad will share details of this program when it reports third-quar­ter financial results on Tuesday, November 12.

Ariad expects to complete the workforce reduction by year-end and yield pre-tax savings of about $26 million in 2014. The company anticipate­s restructur­ing charges associated­ with these changes to be about $5 million in the fourth quarter of 2013. Ariad added that there will be no reductions­ in staff positions in Europe.

Following the workforce reduction,­ Ariad expects to have about 295 employees in the U.S. and Europe.

In mid-Octobe­r, Ariad said it halted a late-stage­ trial of Iclusig in patients with newly diagnosed chronic myeloid leukemia. The decision was taken in tandem with the U.S. Food and Drug Administra­tion as arterial thrombotic­ events were observed in patients treated with Iclusig.


Read more: http://www­.nasdaq.co­m/article/­...k-facts­-20131107-­01955#ixzz­2k33QixHl  

Ariad aufpassen Kursziel weiterhin unter 1 USD