Positive Ergebnisse einer Phase I-Studie

 

Cell Therapeutics and Ariad Pharma Face Challenging Approval Processes

http://www.sys-con.com/node/1721117  

mit Cell; das dauert wohl  noch ein weilchen - mit Sicherheit ein interessanter Wert - der wohl in jeder W - Liste gut  aufgehoben ist -

die brauchen natürlich noch starke Partnerschaften damit Sie Ihre Phase 3 auch bezahlen können - da kommt noch einiges an Kosten auf die zu - Tippe auch auf  weitere Kapitalerhöhungen - im Moment verbrennen  die ja so schon sehr viel Geld -  2010 sind es 147MIo gewesen  und 2009 waren es 117 Millionen

Gruß galway 

 

  Der Anfang einer vielseitigen Präsentation-Show durch die Staaten beginnt 

link:  http://www.thestreet.com/story/11017198/1/...re-conference.html 

 

link: http://www.gurufocus.com/news.php?id=126092 

 

Date(s): 17-Mar-2011 7:36 AM

For a complete listing of our news releases, please click here


CAMBRIDGE, Mass., Mar 17, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that it has
elected to exercise its option with Merck & Co., Inc., to co-promote
ridaforolimus, an investigational mTOR inhibitor, in the sarcoma
indication upon its potential approval in the United States next year.



Based on the terms of the license agreement that ARIAD and Merck entered
into in May 2010 for the development, manufacture and commercialization
of ridaforolimus in oncology, ARIAD has the option to co-promote
ridaforolimus with up to 20 percent of the sales effort for the product
in all indications in the U.S., and Merck will compensate ARIAD for its
sales efforts.


"The decision to co-promote ridaforolimus upon potential launch in 2012
is consistent with our plans to build a fully integrated commercial
oncology company and dovetails with the potential launch of ponatinib,
our investigational pan-BCR-ABL inhibitor, in patients with resistant or
intolerant chronic myeloid leukemia in late 2012 or early 2013," stated
Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.


"By co-promoting ridaforolimus in the U.S., ARIAD will contribute to its
commercial success in the sarcoma indication, gain important commercial
experience in oncology prior to ponatinib's potential approval and
maintain close visibility on Merck's progress and plans for
commercializing ridaforolimus in other cancer indications," he added.


Details of the co-promotion will be finalized in a co-promotion
agreement to be negotiated by ARIAD and Merck. Merck has indicated its
intention to file for marketing approval of ridaforolimus in patients
with metastatic sarcomas this year.
 

 

http://www.thepharmaletter.com/file/102939/...-us-approval.html 

 

Bei Ariad gehen sie wohl alle davon aus, das Ridaforolimus erfolgreich eine Zulassung bekommt. Das ist zwar nicht gänzlich ausgeschlossen, aber das Risiko trägt ja zum größten Teil jetzt Merck & Co, weil die auch die weiteren Entwicklungs- und Zulassungskosten tragen. Dennoch ist so ein Zulassungprozess eine sehr aufwendige Prozedur, und es besteht durchaus die Möglichkeit, dass die Zulassung erst mal versagt wird im ersten Anlauf. Die Versagung der Zulassung hängt nicht alleine davon ab, ob ein Medikament also solches eine Wirksamkeit gegen eine bestimmte Krankheit aufweist. Das sind häufig auch viele andere Formalismen, wie Nebenwirkungen, oder auch bürokratische Hemmnisse. Ridaforolimus als solches ist wirksam gegen verschiedene Krebsarten, das hat die SUCCEED-Studie ja bewiesen, deren vorläufiges Endergebnis bereits im Oktober letzten Jahres kurz angekündigt war. Und es gibt ja schon ähnliche Struktur-verwandte Macrolide, die bereits am Markt erfolgreich eingesetzt sind, aber eben hauptsächlich in der intravenösen Applikation.
Wenn die Zulassung durch die FDA in so einem halben Jahr erfolgen sollte, kann man davon ausgehen, dass sich die Marktkapitalisierung von Merck, aber auch in geringerem Masse bei Ariad weiter erhöht, da man dann auf dem Markt auch verkaufen darf.
Wenn die Zulassung durch die FDA aber, aus welchen Gründen auch immer, im ersten Anlauf versagt wird, dann sehen wir hier eventuell nochmals Kurse bei oder unter $2.00. Das heisst dann aber noch nicht das endgültige Aus für Ridaforolimus, sondern man wird es nochmals probieren, weil das ein wichtiger Markt ist, der bedient werden kann. Und Ariad hat noch weitere, sehr erfolgversprechende Produkte in der Pipeline, deren Zulassung aber noch ein wenig aus ist.  

http://www.tradershuddle.com/20110324190283/...sf-tleo-wdr.html 

 

Nach Hochstufung auf "outperform" bei Kursziel $10.00 durch Williams Capital deutlich erhöhtes Volumen.

"Williams Capital analysts initiated coverage on shares of Ariad Pharmaceutical (NASDAQ: ARIA). They set an “outperform” rating and a $10.00 price target on the stock. They noted that the move was a valuation call."

soeben erschienen

link: http://www.businesswire.com/news/home/...panion-Diagnostic-Test 

 

 

ARIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD to Present New Preclinical Data on Ponatinib at the American Association for Cancer Research Annual Meeting

Date(s): 29-Mar-2011 7:36 AM

For a complete listing of our news releases, please click here


CAMBRIDGE, Mass., Mar 29, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that new
preclinical data on ponatinib,
the company's investigational multi-targeted tyrosine kinase inhibitor,
will be presented at the American Association for Cancer Research (AACR)
Annual Meeting to be held April 2-6, 2011 in Orlando, FL.



ARIAD scientist Joseph M. Gozgit, Ph.D., will present the poster
entitled, "Ponatinib (AP24534), a potent pan-FGFR inhibitor with
activity in multiple FGFR-driven cancer models," on Tuesday, April 5,
2011 between 8:00 am and 12:00 pm. The ARIAD poster will be presented
during the session titled "Experimental and Molecular Therapeutics 25"
in Exhibit Hall A4-C, Poster Section 28, Abstract Number 3560.

About ARIAD


ARIAD's vision is to transform the lives of cancer patients with
breakthrough medicines. The Company's mission is to discover, develop
and commercialize small-molecule drugs to treat cancer in patients with
the greatest and most urgent unmet medical need - aggressive cancers
where current therapies are inadequate. ARIAD's product candidate,
ridaforolimus, is an investigational mTOR inhibitor being developed by
Merck that has successfully completed a Phase 3 clinical trial in
patients with soft-tissue and bone sarcomas and is being studied in
multiple cancer indications. ARIAD's second internally discovered
product candidate, ponatinib, is an investigational pan-BCR-ABL
inhibitor in a pivotal Phase 2 clinical trial in patients with chronic
myeloid leukemia and Ph+ acute lymphoblastic leukemia. For additional
information, please visit www.ariad.com.

SOURCE: ARIAD Pharmaceuticals, Inc.


ARIAD Pharmaceuticals, Inc.
Maria E. Cantor, 617-621-2208
 

 

 a bissl wenig.........finde ich

http://www.streetinsider.com/Analyst+Comments/Barclays+Reiterates+an+Overweight+on+ARIAD+Pharmaceuticals+(ARIA)%3B+Continued+Execution+on+Ponatinib%3B+Preclinical+Solid+Tumor+Data+at+AACR/6396703.html 

 

ARIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD to Present at the Leerink Swann Cancer Roundtable Conference

Date(s): 31-Mar-2011 7:38 AM

For a complete listing of our news releases, please click here


CAMBRIDGE, Mass., Mar 31, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will
present at the Leerink Swann Cancer Roundtable Conference being held at
the Roosevelt Hotel in New York City, New York on Thursday, April 7,
2011. Harvey J. Berger, M.D., chairman and chief executive officer at
ARIAD, will provide an overview of the Company's strong oncology
pipeline and progress on its three lead compounds at 3:30 p.m. (ET).
Timothy P. Clackson, Ph.D., president of research and development and
chief scientific officer at ARIAD, will participate on a lymphoma and
leukemia discussion panel at 2:15 p.m. (ET).



Dr. Berger's 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 of the presentation will be available on the ARIAD website
approximately twenty-four hours after the presentation and will be
archived for three weeks.
 

 

ARIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD Presents New Preclinical Data on Ponatinib in Solid Tumors, Demonstrating Inhibition of All FGF Receptor Kinases

Date(s): 5-Apr-2011 7:35 AM

For a complete listing of our news releases, please click here


ORLANDO, Fla. & CAMBRIDGE, Mass., Apr 05, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced results of
preclinical studies on ponatinib,
its investigational pan-BCR-ABL inhibitor, showing potent inhibition of
all four members of the fibroblast growth factor receptor (FGFR) family
of tyrosine kinases that are abnormally expressed in multiple cancers.
ARIAD scientists are presenting the data this morning at the American
Association for Cancer Research (AACR) Annual Meeting in Orlando,
Florida.



Recent research has established that FGF receptors 1 to 4 are activated
through multiple mechanisms in certain solid tumors and represent
promising targets for antitumor therapy. The new data on ponatinib
demonstrate potent activity against a broad range of tumor cells
activated by all four FGFRs, in vitro and in vivo. In a
panel of 14 cell lines representing multiple different tumor types
including endometrial, bladder, gastric, breast, lung and colon cancer,
ponatinib potently and selectively inhibited FGFR-mediated signaling and
cell growth. Four other tyrosine kinase inhibitors with FGFR inhibitory
activity that are in clinical development were substantially less
active, and none potently blocked all four FGF receptors.


In mouse models of FGFR-driven tumors, daily oral dosing of ponatinib
reduced tumor growth and inhibited signaling in all 3 FGFR-driven models
examined. Ponatinib reduced tumor growth by 80 percent in mouse models
of bladder and endometrial cancers and induced tumor regression in a
model of gastric cancer. Potency was similar to that previously observed
in BCR-ABL-driven models of chronic myeloid leukemia (CML). Importantly,
the Phase 1 trial of ponatinib in CML shows that plasma concentrations
of ponatinib required for inhibition of all four FGFRs can be sustained
at well-tolerated doses in patients.


"These data demonstrate, for the first time, that in addition to its
profile as a pan-inhibitor of BCR-ABL, ponatinib is also an
investigational pan-FGFR inhibitor," stated Timothy
P. Clackson, Ph.D., president of research and development and chief
scientific officer at ARIAD. "The data also show that ponatinib potently
inhibits the activity of all four FGFRs at clinically achievable drug
levels and provide strong rationale for ponatinib's evaluation in
patients with FGFR-driven cancers."
 

 

RIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD Announces Three Exclusive Out-License Agreements to Develop and Commercialize Its ARGENT(TM) Cell-Signaling Regulation Technology

Date(s): 20-Apr-2011 7:31 AM

For a complete listing of our news releases, please  click here

Most Advanced Partnered Programs to Enter Phase 2 Clinical Trials
Maintains Internal Focus on Molecularly Targeted Small-molecule
Anti-cancer Drugs


CAMBRIDGE, Mass., Apr 20, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced execution of
three exclusive out-license agreements for separate aspects of its
ARGENT(TM) cell-signaling regulation technology. The licenses to these
non-core assets provide ARIAD with a combination of equity ownership in
partners, upfront payments, ongoing fees for supply of certain research
reagents, and potential milestone and royalty payments linked to
clinical, regulatory and sales achievements of partners.



The ARGENT technology platform combines chemistry and genetics to allow
specific cell-signaling and gene-expression events to be chemically
activated in whole animals and cultured cells. The technology platform
includes a portfolio of distinct small-molecule "dimerizer" compounds
optimized for specific applications. Dimerizers bring specific proteins
together in cells. The technology is being developed to treat human
disease through cancer vaccines, cell therapy and gene therapy, in each
case featuring small-molecule regulation of cellular activation.


Initial clinical proof of concept has already been demonstrated by
partners and collaborators for two product candidates, which utilize
ARIAD's small-molecule dimerizer drug AP1903, in patients with prostate
cancer and in patients with hematologic malignancies who have undergone
hematopoietic stem cell transplants (HSCT). ARIAD expects its partner to
start Phase 2 clinical trials of both product candidates by early 2012.
AP1903 was discovered and developed by ARIAD scientists.


The technology also provides a family of versatile tools for drug
discovery and biological research. Certain of the underlying
intellectual property was licensed from Harvard and Stanford
Universities. The ARGENT technology was developed and further optimized
by ARIAD scientists using their expertise in structure-based design and
genetics.


"Through the creative licensing of the ARGENT technology in multiple
transactions, we are able to leverage our early investment in this
innovative science and benefit from other companies' expertise in three
distinct areas, while maintaining our focus on our core oncology
therapeutic programs," stated Timothy P. Clackson, Ph.D., president of
research and development and chief scientific officer of ARIAD. "Each of
these transactions provides the opportunity for building short-term and
long-term value for ARIAD, at no further cost to us."


Expanded License Agreement with Bellicum Pharmaceuticals, Inc.


ARIAD and Bellicum Pharmaceuticals, Inc., along with their academic
colleagues at Baylor College of Medicine, have been collaborating for
many years. The two companies have now broadened their previous
agreement as a result of promising clinical data from Phase 1/2 trials
of Bellicum's ARGENT-regulated cancer vaccine and cell-therapy product
candidates, both utilizing AP1903 to achieve chemical induction of
dimerization (CID).


Bellicum's first product candidate, BPX-101 DeCIDe(TM) immunotherapy, is an
autologous dendritic-cell cancer vaccine that includes an
ARGENT-inducible regulatory construct. In the Phase 1/2 trial of
patients with metastatic castrate-resistant prostate cancer at The
University of Texas Health Science Center, Houston, patients received
the Bellicum immunotherapy followed by AP1903 one day later. Data from
the study showed that this small-molecule regulated immunotherapy was
well tolerated and elicited both clinical and antigen-specific immune
responses consistent with patient benefit in prostate cancer.


Bellicum's second product candidate, CaspaCIDe(TM) DLI, is a donor
lymphocyte infusion that contains the ARGENT-inducible safety switch.
This is administered following a T-cell-depleted HSCT. In an
investigator-sponsored Phase 1/2 trial also at Baylor College of
Medicine, pediatric patients with acute lymphoblastic leukemia or acute
myeloid leukemia undergoing HSCT received the CaspaCIDe cell therapy
followed by administration of AP1903 upon diagnosis of graft-vs-host
disease (GvHD). Interim data from the study showed that this
small-molecule regulated cell therapy was well tolerated and rapidly
reversed the deleterious systemic effects of GvHD.


ARIAD's expanded exclusive agreement with Bellicum now covers products
to treat the complications of cell transplantation, such as GvHD, in
addition to certain cancer immunotherapies. ARIAD has an equity stake in
Bellicum and is eligible to receive milestones on regulatory and
clinical progress and royalties on future product sales. Bellicum is
responsible for all manufacturing, regulatory and clinical activities
and will hold the investigational new drug applications for these
programs.


ReGenX Biosciences to Develop ARGENT Gene Therapy Applications


ARIAD and ReGenX Biosciences, LLC along with their academic colleagues
at the University of Pennsylvania Medical Center, have collaborated on
the development of regulated in vivo production of therapeutic
proteins for many years. Previous collaborative studies in non-human
primates established proof of concept showing sustained regulated
production of a therapeutic protein in response to ARIAD's
small-molecule dimerizer drugs for over six years.


ARIAD has exclusively licensed the applications of the ARGENT technology
for regulated gene therapy to ReGenX. ReGenX is combining the ARGENT
technology with its proprietary NAV(TM) gene-delivery technology, thereby
providing a means of pharmacologic control of gene expression and the
potential for greater safety and efficacy in certain disease
applications. The NAV technology is based on over a decade of research
by the founders of ReGenX, funded in part by GlaxoSmithKline plc and
based on a long-standing commitment by the University of Pennsylvania.
ReGenX initially plans to develop the ARGENT products for specific
ocular diseases, metabolic disorders, and infectious diseases, in each
case where precise control of protein production is needed to achieve
the desired patient benefit. Initial applications will involve the use
of another one of ARIAD's portfolio of small-molecule dimerizer drugs,
AP22594, which has been optimized for these uses.


Under the terms of the agreement, ReGenX has exclusive rights to the
ARGENT technology in the development and commercialization of human
therapeutics and vaccines based on in vivo gene delivery. ARIAD
has an equity stake in ReGenX and will receive clinical and regulatory
milestones and royalties on products developed and commercialized
utilizing the ARGENT technology, as well as a portion of sublicensing
revenues.


Research Reagent License with Clontech Laboratories


ARIAD has exclusively licensed the ARGENT technology for use in the
research market to Clontech Laboratories, Inc., a wholly owned
subsidiary of Takara Bio Inc. and a specialty research reagents company
with a substantial profile in molecular and cell biology.


Approximately 2000 academic investigators in over 35 countries worldwide
have used the ARGENT technology in diverse areas of research, including
cancer biology, and more than 400 scientific papers describing its use
have been published. For more than ten years, ARIAD has provided the
ARGENT technology to academic investigators in the form of Regulation
Kits through its web-based Regulation Kit program.


Clontech will assume full responsibility for supplying the technology
worldwide for research applications and will expand ARIAD's current
Regulation Kit program with the goal of making the technology more
broadly available to scientists for in vitro and in vivo
use. ARIAD will continue to manufacture and will supply to Clontech
small-molecule dimerizers specifically designed for use with research
kits. Clontech expects to expand the utility of the ARGENT Regulation
Kit program by combining it with its other core research technologies
including its LivingColors(R) fluorescent proteins and Lenti-X(TM)
viral expression systems, and by expanding access to inducible animal
models of human pathophysiology.


ARIAD will receive an upfront payment from Clontech, as well as payments
for sale of dimerizer reagents to Clontech for its further sale. ARIAD
also will receive milestones based on Clontech achieving predefined
annual sales levels and royalties on net sales of all products
incorporating the ARGENT technology, as well as a portion of
sublicensing revenues.


"These three separate initiatives to license the ARGENT technology
portfolio provide ARIAD with long-term value linked to equity stakes,
milestones and royalties, as well as near-term value through up-front
payments and fees," stated Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. "These licenses allow us to focus on our
core oncology priorities while continuing to benefit from this important
legacy technology that is already showing early clinical promise in
patients with cancer."
 

 

weiter geht die Fahrt nach Norden.........Ach - hier freue ich mich wirklich .......und wohl kein Ende in Sicht..............

 

 

Und kein ende in Sicht. Muss doch Gründe haben?
Kommt da bald was, Übernahme oder Sonstiges?

ARIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD to Webcast Conference Call on Second Quarter 2011 Financial Results

Date(s): 14-Jul-2011 7:35 AM

For a complete listing of our news releases, please  click here


CAMBRIDGE, Mass., Jul 14, 2011 (BUSINESS WIRE) --

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will
host a live webcast of its quarterly conference call at 8:30 a.m. (ET)
on Tuesday, August 2, 2011. Harvey J. Berger, M.D., chairman and chief
executive officer, will host the call. Senior management will discuss
the Company's financial results as of June 30, 2011, key corporate
objectives and additional corporate activities. The Company will
announce the highlights of these topics in a press release to be issued
before the market opens on August 2, 2011 prior to the conference call.



The live webcast can be accessed by visiting the investor relations
section of the Company's website at http://investor.ariad.com.
The call can be accessed by dialing 866-730-5765 (domestic) or
857-350-1589 (international) five minutes prior to the start time and
providing the pass code 69698816. A replay of the call will be available
on the ARIAD website approximately two hours after completion of the
call and will be archived for three weeks 

 

Die Analysten von Jefferies haben das Kursziel für Ariad von $ 11,00 auf $ 160,0 erhöht.

Quelle:
http://www.streetinsider.com/Analyst+Comments/...agement/6640640.html  

bei Ariad.com nachlesbar unter news

und im September bei den Roeadshows gehen wir auf die 20 USD - freue nich schon

 

 

Quartalszahlen sind kombiniert mit sehr gutem Fortschritt bei den Studien. Merck hat bereits Zulassungsantrag für Ridaforolismus gestellt, Zulassung wahrscheinlich im nächsten halben Jahr. Vorläufige klinische Ponatinib Ergebnisse (die zweite Substanz bei Ariad) schon bald erwartet, Patientenaufnahme für die Studien schon abgeschlossen. Die dritte Substanz bei Ariad, der ALK-Inhibitor (anaplastic lymphoma kinase) AP26113, ähnlich dem von Pfizer bereits bekanntem Crizotinib (PF-02341066) ( siehe Wikipedia: http://en.wikipedia.org/wiki/Crizotinib ) geht in die klinische Prüfung.    
Ariad erhält demnach bald weitere Meilensteinzahlungen.

Nachzulesen unter:
http://www.marketwatch.com/story/...s-2011-08-02?reflink=MW_news_stmp  

... dass alle Unterlagen zur Prüfung des Zulassungsantrages für Ridaforolimus vollständig eingereicht wurden:
http://www.marketwatch.com/story/...ational-mtor-inhibitor-2011-10-05

Wie man der Meldung entnehmen kann, wird der Antrag nicht im fast-track Verfahren begutachtet, sondern im normalen Verfahren (Dauer 1 Jahr), weil die FDA anscheinend der Meinung ist, dass es bereits genug gut wirksame Anti-Tumormedikamente am Markt gibt, so dass eine ausreichend gute medizinische Versorgung/Behandlung möglich ist. Allerdings bietet Ridoforolimus eben den Vorteil, dass es einen neuartigen Wirkmechanismus bei oraler Gabe hat, und somit eine bessere Marktdurchdringung geben könnte. Entscheidend wird sein, wie die Patienten auf die Vorzüge gegenüber anderen Mitteln reagieren.
Eine Zulassung kann natürlich auch erst einmal versagt werden, so dass dies in einem solchen Falle sicherlich nochmals zu einem starken Kursrückgang führen wird. Im Moment ist der Kurs recht hoch, und wird bei einer Versagung der Zulassung sicherlich um 50 Proz. oder mehr nochmals einsacken. Jedoch denke ich, dass der neuartige und einzigartige Wirkmechanismus von Ridaforolimus eine Alternative zu herkömmlichen Therapien ermöglicht. Ich schätzte eine Zulassungswahrscheinlichkeit von > 90% für Ridaforolimus spätestens nach dem zweiten Anlauf, wenn der erste Antrag abgelehnt werden sollte.  

hab ich mich verrechnet oder hat die Aktie einen KGV von 77?
Wenn ich mich nicht verrechnet habe ist die Aktie leicht überbewertet! (Sarkasmus!)  

Hast Recht, da stimmt was nicht bei der Aktie, hier gibt's keine Dividende. Ist wahrscheinlich ein Scam, so ähnlich wie bei Genta (WKN A1H6PM ; ISIN US37245M8010). Hab mir neulich auch gedacht, dass die Ariad Aktie viel zu teuer ist, in Anbetracht dessen, das die noch nichts am Markt haben. Der Nennwert der Ariad Aktie ist übrigens bei $0.001. Die Genta Aktie hat den gleichen Nennwert, also $0.001. Genta's Aktienkurs hat derzeit gerade den richtigen Wert, den Nennwert, aber beide Firmen entwickeln schliesslich einen oral wirksamen anti-Tumor Wirkstoff. Ist die Frage, wo man mehr Potential sieht? Sollte also auch noch viel Potential nach unten sein. Wer bringt also schneller ein Medikament durch die Instanzen? Genta oder Ariad?