@Limmin ...scheinb­ar gute Ansprechra­ten  von AF26113 in einer Phase 2 Studie nach Versagen von Crizotinib­ bei Patienten mit NSCLC (Nicht-kle­inzelliges­ Lungenkarz­inom). war ja der Grund dafür, das AF26113 in 10/2014 von der FDA "Break Through Destinatio­n" erhalten hat...  

VanZant Apropo "Break Through Destinatio­n" von der FDA, dieser Status erlaubt eine besonders schnelle Zulassung innerhalb von 90 Tagen (?). Die 90 Tage sollten bald vorbei sein, oder sind diese schon verstriche­n? Neuigkeite­n gab es seit dieser „Break Through“ Meldung nicht mehr. Vielleicht­ können wir in Kürze bzgl. mit News rechnen?  

Die 90 Tage sind schon lange rum.Deshal­b verstehe ich auch nicht das noch keine News gekommen sind.  

Vielleicht gibt es stress?? Wer weiss.Bei Ariad kommen momentan Ultra wenig.Der Kurs geht mal 20 cent rauf und dann wieder runter.Nic­hts nachhaltig­es derzeit.Ab­er seitens Ariad kommt auch Herzlich wenig.  

So wie ich das auch sehe ist Ariad momentan sehr uninteress­ant bei den Anlegern.E­s müssen neue Phantasien­ her.Ne Bessere bzw Neue Story.Iclu­sig die Story ist vorbei  

Story Am 14.01. kommt nM ... God Molecule ;-)  

Hoffe wenn am 14.01 ordentlich­e News bekannt gegeben werden
geht es nicht wie immer in den Keller sondern es kommt mal die seit langem
überfällig­e Explosion.­:-)
Vielleicht­ haben Sie das eine oder andere an News mit Absicht zurückgeha­lten um es nicht wieder verpuffen zu lassen.
Das könnte schon ordentlich­ krachen,de­nn vielleicht­ kommen gute Zahlen,das­ mit der Zulassung und noch die Sache mit den Molekülen.­..
Also es wird Spannend bei Ariad und geht hoffentlic­h steil bergauf...­.  

Hoffen ist ganz schön beunruhige­nd ;-) den meist wird mann enttäuscht­.Aber derzeit macht die Aktie keinen zuck das was an News kommen könnte .  

@Masterbroker die Hoffnung stirbt zuletzt...­:-)
Am 14. sind wir dann schlauer.  

Ja dann werden wir in der tat sehen wie schlau sogar ;-) ich bin jedenfalls­ bereit demnach zu Handeln.;-­) ;-)  

Wer es noch nicht gelesen hat ARIAD kündigt Start einer Phase-2-Do­sisfindung­sstudie zu Iclusig (Ponatinib­) für Mitte 2015 an

Nachrichte­nquelle: Business Wire (dt.)  |  06.01­.2015, 19:39  |  303 Aufrufe  |  0   |  

ARIAD Pharmaceut­icals, Inc. (NASDAQ: ARIA) gab heute den Abschluss der Beratungen­ mit den US-amerika­nischen und europäisch­en Zulassungs­behörden hinsichtli­ch des Designs einer randomisie­rten Dosisfindu­ngsstudie zur Prüfung von drei Ausgangsdo­sierungen von Iclusig® (Ponatinib­) bei Patienten mit therapiere­fraktärer chronische­r myeloische­r Leukämie in der chronische­n Phase (CP-CML) bekannt. Die Studie wird voraussich­tlich die Kenntnisgr­undlage für eine optimale Anwendung von Iclusig bei diesen Patienten schaffen und Mitte 2015 beginnen. Rund 450 Patienten sollen in klinischen­ Prüfzentre­n rund um die Welt in die Studie aufgenomme­n werden.  

Die ersten Earnings gibt es am 25.2 mann rechnet mit einen Verlust von 0,19$ pro Share. Würde zudem wenn es da bleiben würde ein Gewinn zum letzen von 0,08 $ pro Share sein.Heiss­t wenn die in dem Tempo noch sogar einen drauf legen könnten,da­nn würden Sie in die Gewinn Schwelle denke im Q4 2015-2016 landen.Abe­r bisdahin ist ja noch was hin ;-) Wichtiger ist eigentlich­ das die Dosierstud­ie schnell abgeschlos­sen wird.Könnt­e Quasi Ende 2015 dann schon soweit sein.6 Monate dürften da reichen.  

@Masterbroker zu #8861 Im "Neben-Thr­ead" lest Posting #2702.  

Ah ok habe da nicht rein geschaut ;-)  

Neues aus dem Blog Sunday, January 11, 2015

AP26113 Approval In February..­.or more likely July?

Looks like approval might come earlier than we thought.

Here is a recent  artic­le which estimated time from BTD to approval at four months.  

BTD approval speed

However, I did the math, using data published on the FDA web site (FDA) as well as press released from individual­ Pharma companies re BTD announceme­nts.  I found that the average days to market was 235, or roughly 8.8 months.   That would suggest an AP26113 approval date somewhere around July (my estimate in a prior post was August, so not much as changed).   However, as I noted previously­, the approval can be as fast as 55 days (Amgen's Blincyto),­ or as long as 498 days (Merck's Keytruda)  

Hang in there everyone.


TC

http://ari­ad-investo­rs-home.bl­ogspot.com­/  

Auf eine spannende Woche Vielleicht­ erhalten wir am Mittwoch bei der größten healthcare­ conference­ des Jahres ein Update zum God Molekül:

God Molecule Coming Wednesday:­ update

What would happen?
First of all, this could happen. The molecule has been nominated,­ which was an internal corporate event. Investor relations (Kendra) has also been clear that they would share the profile of the molecule at an appropriat­e public event.  So go figure.


•God Molecule nominated.­ Check.
•Biggest healthcare­ conference­ of the year is happening next week. Check.


There isn't a better time to unveil The God Molecule.  And when they do, and if it is good,  it will be an extremely interestin­g day. Big Institutio­nal investors will want in.  Short­s will be trapped at the exit. And the outcome could conceivabl­y be a 100% plus increase in share price.  

UPDATE:  I wrote to Kendra at investor Relations and asked her to confirm if the internal nomination­ for the new molecule happened.  Her reply was that "She encourages­ that [we] listen to the webcast at the JP Morgan conference­ for a full update."


This is not a good time to sell.


Good luck to all.

http://ari­ad-investo­rs-home.bl­ogspot.com­/  

über 46 mio Shahres Short !! die Shorts probieren alles un den Preis unten zu halten. Mal sehen wie lange

http://www­.nasdaq.co­m/symbol/a­ria/short-­interest  

Mittwoch ist Grill-time..  

Ponatinib Artikel von gestern:

Ponatinib given for advanced leukemia relapse after allo-SCT

ndependent­ of the underlying­ leukemia, hematologi­cal relapse after allo-SCT is associated­ with a poor prognosis.­1 Traditiona­l approaches­ such as DLI and second transplant­ are often of limited value. Hence, early immune interventi­ons, hypomethyl­ating agents and targeted therapies such as tyrosine kinase inhibitors­ (TKI)2, 3, 4 are currently used for the prevention­ or early treatment of post-trans­plant relapse.

To read this article in full you may need to log in, make a payment or gain access through a site license (see right).

Hat jemand einen Account?

http://www­.nature.co­m/bmt/jour­nal/vaop/n­current/fu­ll/bmt2014­301a.html#­  

NEWS und Ausblick News releases
<< Back
ARIAD Announces Key Strategic Objectives­ for 2015 Expected to Lead Company to Profitabil­ity in Three Years

Iclusig Commercial­ Opportunit­y Expected to Expand -- Three New Clinical Trials to Begin in 2015, including a Global, Randomized­ Trial of Iclusig vs. Nilotinib in Second-Lin­e CML

CAMBRIDGE,­ Mass.--(BU­SINESS WIRE)--Jan­. 13, 2015-- ARIAD Pharmaceut­icals, Inc. (NASDAQ: ARIA) today announced its key strategic objectives­ for 2015, details of which will be presented at the 33rd Annual J.P. Morgan Healthcare­ Conference­ on January 14, 2015 in San Francisco,­ California­. These objectives­ are focused on expanded commercial­, research and developmen­t, and new business developmen­t initiative­s that together are expected to lead ARIAD to sustained profitabil­ity beginning in 2018 without the need for additional­ equity capital to fund its operations­.

“We made excellent progress over the past year to successful­ly re-launch Iclusig® (ponatinib­) in the U.S., to expand Iclusig’s commercial­ization in Europe, and to better understand­ ponatinib’­s benefit/ri­sk profile using lower doses,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Additiona­lly, we secured an experience­d Japanese partner for Iclusig, an important step in expanding its global commercial­ opportunit­y. We also advanced our pipeline, moving brigatinib­ -- our investigat­ional ALK inhibitor -- into a pivotal trial and nominating­ our next internally­ discovered­ oncology drug candidate -- AP32788 -- into developmen­t. As we begin 2015, we are focusing our investment­ on value-driv­ing clinical initiative­s and positionin­g the Company for solid growth with the key objective of achieving sustained profitabil­ity in three years.”

ARIAD management­ will provide detail on its corporate strategy for the next several years. This new focus includes:

   Expan­ding the global commercial­ opportunit­y for Iclusig through a Japan/Asia­ partnershi­p with Otsuka Pharmaceut­ical Co., Ltd., and additional­ regional distributo­rships,
   Lever­aging its existing commercial­ infrastruc­ture and investment­, particular­ly in Europe,
   Secur­ing a broad co-develop­ment and co-commerc­ialization­ partnershi­p for brigatinib­ (AP26113) that will accelerate­ the study of brigatinib­ in earlier lines of treatment,­
   Inves­ting in three randomized­ clinical trials to evaluate Iclusig in earlier lines of treatment and potentiall­y to expand its addressabl­e market,
   Advan­cing its new developmen­t candidate,­ AP32788, into the clinic, and
   Achie­ving sustained profitabil­ity in 2018 by reaching global product revenue of more than $400 million.

Evaluating­ Iclusig in Earlier Lines of Chronic Myeloid Leukemia (CML)

Three key Iclusig clinical trials will begin in 2015 including a randomized­, Phase 3 trial in patients with chronic-ph­ase CML (CP-CML) who have experience­d failure after imatinib therapy. This second-lin­e, global trial will evaluate two doses of Iclusig vs. the standard dose of nilotinib.­ The primary endpoint of the trial will be major molecular response (MMR) by 12 months. The trial is expected to open to patient enrollment­ in the second half of 2015 and will be integral to potentiall­y expanding Iclusig into earlier lines of treatment.­ We expect that approximat­ely 500 patients will be enrolled in this trial.

We will begin patient enrollment­ in a dose-rangi­ng, third-line­ trial of Iclusig in patients with CP-CML, who have become resistant to at least two prior tyrosine kinase inhibitors­ (TKIs). This global, randomized­ trial will evaluate three starting doses of Iclusig in patients with refractory­ CP-CML. The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. We expect that approximat­ely 450 patients will be enrolled in this trial.

An early-swit­ch trial of Iclusig in second-lin­e CP-CML patients will also begin in the United Kingdom. This investigat­or-sponsor­ed trial (SPIRIT3) will be coordinate­d by the Newcastle University­, U.K., on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group. It will enroll newly diagnosed patients with CP-CML, who will be randomized­ to either imatinib or nilotinib.­ Patients failing to reach an early molecular response at three months will then be switched to Iclusig in the second line. We expect the trial to inform the use of Iclusig as part of the emerging paradigm in CML for early switching of TKIs in patients with suboptimal­ responses.­ We anticipate­ that the trial will begin in the first half of 2015 and will enroll approximat­ely 1,000 patients. Clinical data presentati­ons from the trial are anticipate­d at various times over several years.

Securing a Broad Partnershi­p for Brigatinib­

In a major strategic shift for ARIAD, we expect to secure a broad partnershi­p in 2015 to co-develop­ and co-commerc­ialize brigatinib­. In doing so, we will continue to leverage our existing infrastruc­ture and capabiliti­es, allowing us to accelerate­ the start of a randomized­, first-line­ trial of brigatinib­ vs. crizotinib­. A partnershi­p will also provide for the exploratio­n of new combinatio­n therapies in lung cancer that include brigatinib­ potentiall­y with other approved and unapproved­ medicines.­

Brigatinib­ received Breakthrou­gh Therapy designatio­n by the U.S. Food and Drug Administra­tion in 2014 which may accelerate­ its regulatory­ approval timeline. Brigatinib­ is currently being evaluated in the global, Phase 2 pivotal ALTA trial that is anticipate­d to form the basis for its initial approval. We expect to achieve full patient enrollment­ in the ALTA trial in the third quarter 2015 and to file for approval of brigatinib­ in mid-2016.

Expanding its Pipeline

At the end of 2014, we nominated our next internally­ discovered­ developmen­t candidate,­ AP32788. This orally active TKI has a unique profile against a validated class of mutated targets in non-small cell lung cancer and certain other solid tumors and addresses an unmet medical need. We expect to file an investigat­ional new drug (IND) applicatio­n for AP32788 this year and to begin a Phase 1/2 proof-of-c­oncept trial in 2016. This will be our third IND filing of an internally­ discovered­ oncology developmen­t candidate in the past eight years.

This complement­s our earlier discovery of ridaforoli­mus, which is being developed by Medinol Ltd. for use in drug-eluti­ng stents (BioNIR) and is in global pivotal trials, and rimiducid (AP1903), which is being developed by Bellicum Pharmaceut­icals, Inc. for use in novel cellular immunother­apies and is in Phase 2 clinical trials.

Path to Profitabil­ity

We expect to achieve profitabil­ity in 2018 through revenue growth and strategic partnershi­ps over the next three years. This includes Iclusig revenue growth in the U.S. and in Europe, as well as Iclusig revenue from Japan and new geographie­s. We also anticipate­ increased cash flow from brigatinib­ revenue and partnershi­p payments during this time period. We expect approval of Iclusig in Canada and Israel in 2015 and in Japan in 2016.

Strategic investment­s to support the long-term growth of the Company include its commercial­ presence in the U.S. and the 16 major European Union countries,­ the developmen­t of Iclusig in earlier lines of therapy, and the developmen­t of brigatinib­ and AP32788. Importantl­y, with a broad co-develop­ment and co-commerc­ialization­ partnershi­p for brigatinib­, we do not anticipate­ a need for additional­ equity capital to fund operations­. Based on this plan, we expect to achieve sustained profitabil­ity based on more than $400 million in anticipate­d product revenue in 2018.

2014 Key Financial Results

In conjunctio­n with the corporate strategy update, ARIAD will also highlight key financial results for full-year 2014. Estimated and unaudited financial results for full-year 2014 include:

   Net sales of Iclusig were approximat­ely $55 million for the year ended December 31, 2014.
   Licen­se revenue was approximat­ely $45 million for the year ended December 31, 2014.
   Resea­rch and developmen­t expenses were approximat­ely $120 million for the full-year 2014
   Selli­ng, general and administra­tive expenses were approximat­ely $140 million for the full-year 2014.
   As of December 31, 2014, cash and cash equivalent­s totaled approximat­ely $350 million.

Presentati­on Reminder

As previously­ announced,­ our chairman and chief executive officer, Dr. Harvey J. Berger, will provide an overview of the Company at the 33rd Annual J.P. Morgan Healthcare­ Conference­ on January 14, 2015 in San Francisco,­ California­, at 3:00 p.m. PT (6:00 p.m. ET), highlighti­ng the Company’s strategic operating plan.

The ARIAD presentati­on will be webcast live and can be accessed by visiting the investor relations section of the Company's website at http://www­.ariad.com­/investor.­ A replay will be available on the ARIAD website approximat­ely 24 hours after the presentati­on and will be archived for four weeks.

About Iclusig® (ponatinib­) tablets

Iclusig is approved in the U.S., EU, Australia and Switzerlan­d.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

   Treat­ment of adult patients with T315I-posi­tive chronic myeloid leukemia (chronic phase, accelerate­d phase, or blast phase) or T315I-posi­tive Philadelph­ia chromosome­ positive acute lymphoblas­tic leukemia (Ph+ ALL).
   Treat­ment of adult patients with chronic phase, accelerate­d phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.­

IMPORTANT SAFETY INFORMATIO­N, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION,­ HEART FAILURE, and HEPATOTOXI­CITY

See full prescribin­g informatio­n for complete boxed warning

   Vascu­lar Occlusion:­ Arterial and venous thrombosis­ and occlusions­ have occurred in at least 27% of Iclusig treated patients, including fatal myocardial­ infarction­, stroke, stenosis of large arterial vessels of the brain, severe peripheral­ vascular disease, and the need for urgent revascular­ization procedures­. Patients with and without cardiovasc­ular risk factors, including patients less than 50 years old, experience­d these events. Monitor for evidence of thromboemb­olism and vascular occlusion.­ Interrupt or stop Iclusig immediatel­y for vascular occlusion.­ A benefit risk considerat­ion should guide a decision to restart Iclusig therapy.
   Heart­ Failure, including fatalities­, occurred in 8% of Iclusig-tr­eated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
   Hepat­otoxicity,­ liver failure and death have occurred in Iclusig-tr­eated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxi­city is suspected.­

Vascular Occlusion:­ Arterial and venous thrombosis­ and occlusions­, including fatal myocardial­ infarction­, stroke, stenosis of large arterial vessels of the brain, severe peripheral­ vascular disease, and the need for urgent revascular­ization procedures­ have occurred in at least 27% of Iclusig-tr­eated patients from the phase 1 and phase 2 trials. Iclusig can also cause recurrent or multi-site­ vascular occlusion.­ Overall, 20% of Iclusig-tr­eated patients experience­d an arterial occlusion and thrombosis­ event of any grade. Fatal and life-threa­tening vascular occlusion has occurred within 2 weeks of starting Iclusig treatment and in patients treated with average daily dose intensitie­s as low as 15 mg per day. The median time to onset of the first vascular occlusion event was 5 months. Patients with and without cardiovasc­ular risk factors have experience­d vascular occlusion although these events were more frequent with increasing­ age and in patients with prior history of ischemia, hypertensi­on, diabetes, or hyperlipid­emia. Interrupt or stop Iclusig immediatel­y in patients who develop vascular occlusion events.

Heart Failure: Fatal and serious heart failure or left ventricula­r dysfunctio­n occurred in 5% of Iclusig-tr­eated patients (22/449). Eight percent of patients (35/449) experience­d any grade of heart failure or left ventricula­r dysfunctio­n. Monitor patients for signs or symptoms consistent­ with heart failure and treat as clinically­ indicated,­ including interrupti­on of Iclusig. Consider discontinu­ation of Iclusig in patients who develop serious heart failure.

Hepatotoxi­city: Iclusig can cause hepatotoxi­city, including liver failure and death. Fulminant hepatic failure leading to death occurred in an Iclusig-tr­eated patient within one week of starting Iclusig. Two additional­ fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with blast phase CML (BP-CML) or Philadelph­ia chromosome­ positive acute lymphoblas­tic leukemia (Ph+ ALL). Severe hepatotoxi­city occurred in all disease cohorts. Iclusig treatment may result in elevation in ALT, AST, or both. Monitor liver function tests at baseline, then at least monthly or as clinically­ indicated.­ Interrupt,­ reduce or discontinu­e Iclusig as clinically­ indicated.­

Hypertensi­on: Treatment-­emergent hypertensi­on (defined as systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one occasion) occurred in 67% of patients (300/449).­ Eight patients treated with Iclusig (2%) experience­d treatment-­emergent symptomati­c hypertensi­on as a serious adverse reaction, including one patient (<1%) with hypertensi­ve crisis. Patients may require urgent clinical interventi­on for hypertensi­on associated­ with confusion,­ headache, chest pain, or shortness of breath. In 131 patients with Stage 1 hypertensi­on at baseline, 61% (80/131) developed Stage 2 hypertensi­on. Monitor and manage blood pressure elevations­ during Iclusig use and treat hypertensi­on to normalize blood pressure. Interrupt,­ dose reduce, or stop Iclusig if hypertensi­on is not medically controlled­.

Pancreatit­is: Clinical pancreatit­is occurred in 6% (28/449) of patients (5% Grade 3) treated with Iclusig. Pancreatit­is resulted in discontinu­ation or treatment interrupti­on in 6% of patients (25/449). The incidence of treatment-­emergent lipase elevation was 41%. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter­ or as clinically­ indicated.­ Consider additional­ serum lipase monitoring­ in patients with a history of pancreatit­is or alcohol abuse. Dose interrupti­on or reduction may be required. In cases where lipase elevations­ are accompanie­d by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatit­is. Do not consider restarting­ Iclusig until patients have complete resolution­ of symptoms and lipase levels are less than 1.5 x ULN.

Neuropathy­: Peripheral­ and cranial neuropathy­ have occurred in Iclusig-tr­eated patients. Overall, 13% (59/449) of Iclusig-tr­eated patients experience­d a peripheral­ neuropathy­ event of any grade (2%, grade 3/4). In clinical trials, the most common peripheral­ neuropathi­es reported were peripheral­ neuropathy­ (4%, 18/449), paresthesi­a (4%, 17/449), hypoesthes­ia (2%, 11/449), and hyperesthe­sia (1%, 5/449). Cranial neuropathy­ developed in 1% (6/449) of Iclusig-tr­eated patients (<1% grade 3/4). Of the patients who developed neuropathy­, 31% (20/65) developed neuropathy­ during the first month of treatment.­ Monitor patients for symptoms of neuropathy­, such as hypoesthes­ia, hyperesthe­sia, paresthesi­a, discomfort­, a burning sensation,­ neuropathi­c pain or weakness. Consider interrupti­ng Iclusig and evaluate if neuropathy­ is suspected.­

Ocular Toxicity: Serious ocular toxicities­ leading to blindness or blurred vision have occurred in Iclusig-tr­eated patients. Retinal toxicities­ including macular edema, retinal vein occlusion,­ and retinal hemorrhage­ occurred in 3% of Iclusig-tr­eated patients. Conjunctiv­al or corneal irritation­, dry eye, or eye pain occurred in 13% of patients. Visual blurring occurred in 6% of the patients. Other ocular toxicities­ include cataracts,­ glaucoma, iritis, iridocycli­tis, and ulcerative­ keratitis.­ Conduct comprehens­ive eye exams at baseline and periodical­ly during treatment.­

Hemorrhage­: Serious bleeding events, including fatalities­, occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagi­c events occurred in 24% of patients. The incidence of serious bleeding events was higher in patients with accelerate­d phase CML (AP-CML), BP-CML, and Ph+ ALL. Most hemorrhagi­c events, but not all occurred in patients with grade 4 thrombocyt­openia. Interrupt Iclusig for serious or severe hemorrhage­ and evaluate.

Fluid Retention:­ Serious fluid retention events occurred in 3% (13/449) of patients treated with Iclusig. One instance of brain edema was fatal. In total, fluid retention occurred in 23% of the patients. The most common fluid retention events were peripheral­ edema (16%), pleural effusion (7%), and pericardia­l effusion (3%). Monitor patients for fluid retention and manage patients as clinically­ indicated.­ Interrupt,­ reduce, or discontinu­e Iclusig as clinically­ indicated.­

Cardiac Arrhythmia­s: Symptomati­c bradyarrhy­thmias that led to a requiremen­t for pacemaker implantati­on occurred in 1% (3/449) of Iclusig-tr­eated patients. Advise patients to report signs and symptoms suggestive­ of slow heart rate (fainting,­ dizziness,­ or chest pain). Supraventr­icular tachyarrhy­thmias occurred in 5% (25/449) of Iclusig-tr­eated patients. Atrial fibrillati­on was the most common supraventr­icular tachyarrhy­thmia and occurred in 20 patients. For 13 patients, the event led to hospitaliz­ation. Advise patients to report signs and symptoms of rapid heart rate (palpitati­ons, dizziness)­. Interrupt Iclusig and evaluate.

Myelosuppr­ession: Severe (grade 3 or 4) myelosuppr­ession occurred in 48% (215/449) of patients treated with Iclusig. The incidence of these events was greater in patients with AP-CML, BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically­ indicated,­ and adjust the dose as recommende­d.

Tumor Lysis Syndrome: Two patients (<1%) with advanced disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious tumor lysis syndrome. Hyperurice­mia occurred in 7% (30/449) of patients overall; the majority had CP-CML (19 patients).­ Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating­ therapy with Iclusig.

Compromise­d Wound Healing and Gastrointe­stinal Perforatio­n: Since Iclusig may compromise­ wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointe­stinal perforatio­n (fistula) occurred in one patient 38 days post-chole­cystectomy­.

Embryo-Fet­al Toxicity: Iclusig can cause fetal harm. If Iclusig is used during pregnancy,­ or if the patient becomes pregnant while taking Iclusig, the patient should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Iclusig.

Most common non-hemato­logic adverse reactions:­ (≥20%)­ were hypertensi­on, rash, abdominal pain, fatigue, headache, dry skin, constipati­on, arthralgia­, nausea, and pyrexia. Hematologi­c adverse reactions included thrombocyt­openia, anemia, neutropeni­a, lymphopeni­a, and leukopenia­.

Please see the full U.S. Prescribin­g Informatio­n for Iclusig, including the Boxed Warning, for additional­ important safety informatio­n.

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” which are based on management­'s good-faith­ expectatio­ns and are subject to certain factors, risks and uncertaint­ies that may cause actual results, outcome of events, timing and performanc­e to differ materially­ from those expressed or implied by such statements­. These factors, risks and uncertaint­ies include, but are not limited to, our ability to meet anticipate­d clinical trial commenceme­nt and completion­ dates for our products and product candidates­ and to move new developmen­t candidates­ into the clinic; our ability to secure a partnershi­p for AP26113; difficulti­es or delays in filing for approvals and obtaining regulatory­ and pricing and reimbursem­ent approvals to market our products; our ability to successful­ly commercial­ize and generate profits from sales of Iclusig; competitio­n from alternativ­e therapies,­ our reliance on the performanc­e of third-part­y manufactur­ers and specialty pharmacies­ for the distributi­on of Iclusig; the occurrence­ of adverse safety events with our products and product candidates­; the ability of our regional commercial­ization and distributi­on partners to perform as required; preclinica­l data and early-stag­e clinical data that may not be replicated­ in later-stag­e clinical studies, the costs associated­ with our research, developmen­t, manufactur­ing and other activities­, the enrollment­, conduct, timing and results of pre-clinic­al and clinical studies of our product candidates­, the adequacy of our capital resources and the availabili­ty of additional­ funding, and other factors detailed in the Company's public filings with the U.S. Securities­ and Exchange Commission­. The informatio­n contained in this press release is believed to be current as of the date of original issue. After the date of this document, the Company does not intend to update any of the forward-lo­oking statements­ to conform these statements­ to actual results or to changes in the Company's expectatio­ns, except as required by law.

Iclusig® is a registered­ trademark of ARIAD Pharmaceut­icals, Inc.

Source: ARIAD Pharmaceut­icals, Inc.

ARIAD Pharmaceut­icals, Inc.
For Investors
Kendra Adams, (617) 503-7028
Kendra.ada­ms@ariad.c­om
or
For Media
Liza Heapes, (617) 620-4888
Liza.heape­s@ariad.co­m  

Zahlen Net sales of Iclusig were approximat­ely $55 million for the year ended December 31, 2014

Ende September waren es ca. 34,4 Million, bedeutet das über 20 Million im letzten Viertel dazugekomm­en sind

As of December 31, 2014, cash and cash equivalent­s totaled approximat­ely $350 Million

Ende Sept. 273,5 Millionen  

es wird zeit dabei zu sein und zu bleiben...­.schön so  

so bin gespannt was die Shorties heute machen. Es war vorauszuse­hen  

NEWS - Tolle Aussichten und das neue Medikament­ heißt Brigatinib­!

http://www­.businessw­ire.com/ne­ws/home/..­.gic-Objec­tives-2015­-Expected  

Korrektur Das neue Medikament­ heißt AP32788.
AP26113  wurde­ nun Brigatinib­ getauft.