(Registrieren)

Amgen to Present Pivotal Data From Four Phase 3 Studies at the ECCO 15 - ESMO 34 Congress

Geschrieben am 16-09-2009

Thousand Oaks, California (ots/PRNewswire) -

- Key Denosumab and Vectibix(R) (Panitumumab) Data to be
Presented

Amgen (Nasdaq: AMGN) today announced it will present detailed
data from four Phase 3 studies as well as other data at the ECCO 15 -
ESMO 34 European Multidisciplinary Congress, September 20 - 24, 2009
in Berlin, Germany.

Researchers will present data from two Phase 3 head-to-head
studies evaluating denosumab versus Zometa(R) (zoledronic acid) for
the treatment of bone metastases in patients with advanced breast
cancer (the '136' study) and the treatment of bone metastases in
advanced cancer patients with solid tumors (not including breast and
prostate cancer) or multiple myeloma (the '244' study).

Detailed data will also be presented from two Phase 3 studies
evaluating Vectibix(R) (panitumumab) in combination with chemotherapy
for the first-line and second-line treatment of metastatic colorectal
cancer (the '203' and '181' trials, respectively).

"Amgen is very pleased to be presenting these important data from
the denosumab and Vectibix development programs," said Roger M.
Perlmutter, M.D., Ph.D., executive vice president of Research and
Development at Amgen. "The data from these trials demonstrate that
both denosumab and Vectibix have the potential to improve outcomes in
patients suffering from cancer."

SELECTED ABSTRACTS OF INTEREST

Identified below are selected abstracts of interest on Amgen
research. Updated data will be presented at the meeting.


Denosumab
-- A double-blind, randomized study of denosumab versus zoledronic acid
for the treatment of bone metastases in patients with advanced cancer
(excluding breast and prostate cancer) or multiple myeloma
Lead Author: Henry, D.
Abstract No. 20LBA (Monday, Sept. 21, 2009, 12:45 -13:00 CEST)
-- Denosumab versus zoledronic acid for the treatment of breast cancer
patients with bone metastases: Results of a randomized Phase 3 study
Lead Author: Stopeck, A.
Abstract No. 2LBA (Tuesday, Sept. 22, 2009, 14:15 - 14:30 CEST)
-- Overall survival in men with and without prevalent vertebral fracture
receiving androgen deprivation therapy for nonmetastatic prostate
cancer
Lead Author: Smith, M.
Abstract No. 7005 (Monday, Sept. 21, 2009, 12:15 -12:45 CEST)
Vectibix
-- Randomized Phase 3 study of panitumumab with FOLFIRI vs FOLFIRI alone
as second-line treatment (tx) in patients (pts) with metastatic
colorectal cancer (mCRC)
Lead Author: Peeters, M.
Abstract No. 14LBA (Tuesday, Sept. 22, 2009, 10:45 - 11:00 CEST)
-- Randomized Phase 3 study of panitumumab with FOLFOX compared to
FOLFOX alone as first-line treatment (tx) for metastatic colorectal
cancer (mCRC): The PRIME trial
Lead Author: Douillard, J.Y.
Abstract No. 10LBA (Thursday, Sept. 24, 2009, 11:00 - 11:15 CEST)


An analyst/investor event will also be held from the Congress on
September 24th, at 6:30 a.m. ET to discuss data presented at
ECCO-ESMO. A webcast of the event can be found on Amgen's Web site at
www.amgen.com, under Investors. The audio webcast will be archived
and available for replay for at least 72 hours.

About Denosumab

Denosumab is the first fully human monoclonal antibody in late
stage clinical development that specifically targets RANK Ligand, the
essential regulator of osteoclasts (the cells that break down bone).
With more than 19,000 patients in trials across indications
worldwide, the denosumab development program is the largest ever
initiated by Amgen. This broad and deep development program
demonstrates Amgen's commitment to researching and delivering
pioneering medicines to patients with unmet medical needs. Amgen is
studying denosumab in numerous tumor types across the spectrum of
cancer induced bone disease. Over 11,000 patients have been enrolled
in the denosumab oncology clinical trials testing the drug for bone
loss and destruction associated with cancer treatment-induced bone
loss in breast and prostate cancers, for the prevention of skeletal
related events due to the spread of cancer to the bone in multiple
myeloma and multiple solid tumors, and for its potential to delay
bone metastases in prostate cancer.

In two phase 3 skeletal related events studies reported to date,
the incidence of adverse events and serious adverse events was
consistent with what has previously been reported for denosumab and
Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in both
treatment groups.

About Vectibix

Vectibix is the first fully human anti-EGFR approved by the U.S.
Food and Drug Administration (FDA) for the treatment of mCRC.
Vectibix was approved in the United States in September 2006 as a
monotherapy for the treatment of patients with EGFR expressing mCRC
after disease progression on or following fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.

In December 2007, the European Commission granted a conditional
marketing authorization for Vectibix as monotherapy for the treatment
of patients with EGFR-expressing mCRC with wild-type KRAS genes after
failure of standard chemotherapy regimens. Vectibix has been launched
in over 20 countries, including Switzerland, Australia and Canada.
Applications in the rest of the world are pending.

The effectiveness of Vectibix as a single agent for the treatment
of EGFR-expressing, metastatic colorectal carcinoma is based on
progression-free survival. Currently no data are available that
demonstrate an improvement in disease-related symptoms or increased
survival with Vectibix. Vectibix has not shown a treatment benefit
for patients whose tumors had KRAS mutations in codon 12 or 13.

Important Product Safety Information

Dermatologic Toxicity: Dermatologic toxicities occurred in 89
percent of patients and were severe (NCI-CTC grade 3 and higher) in
12 percent of patients receiving Vectibix monotherapy. Withhold
Vectibix for dermatologic toxicities that are grade 3 or higher or
are considered intolerable. If toxicity does not improve to lesser
than or equal to grade 2 within 1 month, permanently discontinue
Vectibix. The clinical manifestations included, but were not limited
to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation,
paronychia, dry skin, and skin fissures. Subsequent to the
development of severe dermatologic toxicities, infectious
complications, including sepsis, septic death, and abscesses
requiring incisions and drainage were reported.

Infusion Reactions: Severe infusion reactions occurred in
approximately 1 percent of patients. Severe infusion reactions
included anaphylactic reactions, bronchospasm, and hypotension.
Although not reported with Vectibix, fatal infusion reactions have
occurred with other monoclonal antibody products. Stop infusion if a
severe infusion reaction occurs. Depending on the severity and/or
persistence of the reaction, permanently discontinue Vectibix.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was one
of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our
pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statements

This news release contains forward-looking statements that are
based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those described.
All statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements, including
estimates of revenues, operating margins, capital expenditures, cash,
other financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and prescriber
patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below
and more fully described in the Securities and Exchange Commission
(SEC) reports filed by Amgen, including Amgen's most recent annual
report on Form 10-K and most recent periodic reports on Form 10-Q and
Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and
8-K for additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing
this information as of Sept. 16, 2009 and expressly disclaims any
duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results
may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and become
a commercial product. Further, preclinical results do not guarantee
safe and effective performance of product candidates in humans. The
complexity of the human body cannot be perfectly, or sometimes, even
adequately modeled by computer or cell culture systems or animal
models. The length of time that it takes for us to complete clinical
trials and obtain regulatory approval for product marketing has in
the past varied and we expect similar variability in the future. We
develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates
that are derived from relationships may be subject to disputes
between the parties or may prove to be not as effective or as safe as
we may have believed at the time of entering into such relationship.
Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and products liability claims. We depend on third parties
for a significant portion of our manufacturing capacity for the
supply of certain of our current and future products and limits on
supply may constrain sales of certain of our current products and
product candidate development.

In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and health
care cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with other
companies with respect to some of our marketed products as well as
for the discovery and development of new products. We believe that
some of our newer products, product candidates or new indications for
existing products, may face competition when and as they are approved
and marketed. Our products may compete against products that have
lower prices, established reimbursement, superior performance, are
easier to administer, or that are otherwise competitive with our
products. In addition, while we routinely obtain patents for our
products and technology, the protection offered by our patents and
patent applications may be challenged, invalidated or circumvented by
our competitors and there can be no guarantee of our ability to
obtain or maintain patent protection for our products or product
candidates. We cannot guarantee that we will be able to produce
commercially successful products or maintain the commercial success
of our existing products. Our stock price may be affected by actual
or perceived market opportunity, competitive position, and success or
failure of our products or product candidates. Further, the discovery
of significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our business
and results of operations.

The scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration (FDA) for the products. The products are
not approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses. Only the FDA
can determine whether the products are safe and effective for these
uses. Healthcare professionals should refer to and rely upon the
FDA-approved labeling for the products, and not the information
discussed in this news release.

CONTACT: Amgen, Thousand Oaks
Christine Regan: +1-805-447-5476 (media)
Lisa Rooney: +1-805-447-6437 (media)
Arvind Sood: +1-805-447-1060 (investors)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

ots Originaltext: Amgen Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media, Christine Regan, +1-805-447-5476, or Lisa Rooney,
+1-805-447-6437, or Investors, Arvind Sood, +1-805-447-1060, all of
Amgen. Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO


Kontaktinformationen:

Leider liegen uns zu diesem Artikel keine separaten Kontaktinformationen gespeichert vor.
Am Ende der Pressemitteilung finden Sie meist die Kontaktdaten des Verfassers.

Neu! Bewerten Sie unsere Artikel in der rechten Navigationsleiste und finden
Sie außerdem den meist aufgerufenen Artikel in dieser Rubrik.

Sie suche nach weiteren Pressenachrichten?
Mehr zu diesem Thema finden Sie auf folgender Übersichtsseite. Desweiteren finden Sie dort auch Nachrichten aus anderen Genres.

http://www.bankkaufmann.com/topics.html

Weitere Informationen erhalten Sie per E-Mail unter der Adresse: info@bankkaufmann.com.

@-symbol Internet Media UG (haftungsbeschränkt)
Schulstr. 18
D-91245 Simmelsdorf

E-Mail: media(at)at-symbol.de

225331

weitere Artikel:
  • EANS-Adhoc: Vorstand der Deutsche Balaton Aktiengesellschaft beschließt Aktienrückkauf -------------------------------------------------------------------------------- Ad-hoc-Meldung nach § 15 WpHG übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- 16.09.2009 Der Vorstand der Deutsche Balaton Aktiengesellschaft, Heidelberg, ISIN DE0005508204, hat am 16.09.2009 mit Zustimmung des Aufsichtsrats der Gesellschaft vom 16.09.2009 beschlossen, bis zu weitere 270.000 eigene Aktien mehr...

  • EANS-Adhoc: Vorarlberger Landes- und Hypothekenbank AG / Verkauf der Hypo Investmentbank -------------------------------------------------------------------------------- Ad-hoc-Mitteilung übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- 16.09.2009 Ad-hoc-Meldung gemäß § 48d BörseG Verkauf der Hypo Investmentbank (Liechtenstein) AG Die Vorarlberger Landes- und Hypothekenbank Aktiengesellschaft hat am 16. September 2009 ihre Anteile an der Hypo Investmentbank (Liechtenstein)AG mehr...

  • EANS-Adhoc: Valartis Gruppe erwirbt Hypo Investment Bank (Liechtenstein) AG -------------------------------------------------------------------------------- Ad-hoc-Mitteilung übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- 16.09.2009 Mit dem Erwerb der Hypo Investment Bank (Liechtenstein) AG baut die Valartis Gruppe ihre Private Banking Aktivitäten substantiell aus und steigert die verwalteten Vermögenswerte auf rund CHF 6 Mrd. Die Privatbank in Liechtenstein, mehr...

  • EANS-Adhoc: Valartis Group acquires Hypo Investment Bank (Liechtenstein) AG -------------------------------------------------------------------------------- ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- 16.09.2009 The acquisition of Hypo Investment Bank (Liechtenstein) AG is a substantial addition to the private banking activities of Valartis Group, taking assets under management to around CHF 6 billion. The Liechtenstein mehr...

  • EANS-Adhoc: Le groupe Valartis acquiert Hypo Investment Bank (Liechtenstein) AG -------------------------------------------------------------------------------- Communiqué Adhoc transmis par euro adhoc. L'émetteur est tenu responsable du contenu. -------------------------------------------------------------------------------- 16.09.2009 En acquérant Hypo Investment Bank (Liechtenstein) AG, le groupe Valartis étend considérablement ses activités de private banking et porte ses actifs sous gestion à quelque 6 milliards de CHF. Forte de 50 collaborateurs, cette banque privée du Liechtenstein, une filiale de Vorarlberger mehr...

Mehr zu dem Thema Finanzen

Der meistgelesene Artikel zu dem Thema:

Century Casinos wurde in Russell 2000 Index aufgenommen

durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Exzellent
Sehr gut
gut
normal
schlecht