Ariad Pharmaceuticals - der letzte Thread

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 zu 2,25 Ask 10700 zu 2,26  

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.
 

ziel 1 USD  

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.  

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.  

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.
 

Stimme dem zu...!

 

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

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....  

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.  

 

"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"  

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.)
 

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 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
 

Chance bekommt den Hintern nicht hoch die Aktie trotz schon positiven Berichten ueber das Medikament  

 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?

 

Dr. Cortes auf Entscheidungen bei Ariad bzw. der FDA Einfluss haben. Ist Dr. Cortes einer der leitenden Studienärzte gewesen?  

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 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 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.
 

Was hat das jetzt genau zu bedeuten?

 

(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  

aufpassen Kursziel weiterhin unter 1 USD