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More than 200 abstracts at ASH and SABCS reveal potential compelling
patient benefits from Novartis Oncology current and pipeline
therapies |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Tasigna front-line data demonstrating potential in newly
diagnosed patients with a life-threatening type of leukemia to be
featured in two oral sessions at ASH
* Exjade results at ASH to show benefits for chronically transfused
patients by significantly reducing toxic iron that can damage key
organs
* New long-term data from major independent breast cancer trial at
SABCS to report on optimal post-surgery treatment strategy,
Femara vs. tamoxifen
* Multiple Zometa studies at SABCS to affirm anti-cancer activity
in patients with early-stage breast cancer
Basel, December 4, 2008 - More than 200 abstracts from therapies
across the Novartis Oncology portfolio will be presented at two
December medical congresses, providing new data and profiling
potential patient benefits from ongoing collaboration with the
oncology community.
The American Society of Hematology (ASH) annual meeting, beginning
December 6th in San Francisco, CA, will feature 34 oral presentations
on the Novartis Oncology portfolio including 20 on Glivec®
(imatinib), six on Tasigna® (nilotinib), five on Exjade®
(deferasirox) and three on products in development. The CTRC-AACR
San Antonio Breast Cancer Symposium (SABCS), beginning December 10th,
will feature four oral presentations, including three on Femara®
(letrozole) and one on Zometa® (zoledronic acid).
"Our robust portfolio and dedication to oncology research is
ultimately about providing patients and their physicians with new
treatment options to address unmet medical needs," said David
Epstein, CEO and President of Novartis Oncology. "We are pleased that
our ongoing work with experts in the fields of oncology and
hematology continue to provide valuable new insights across multiple
cancer types."
The most significant presentations at ASH include:
* Tasigna data showing its benefit in the first-line treatment
setting for patients with chronic myeloid leukemia, in two oral
presentations (ASH Abstracts #181 & 446; Monday, December 8,
2008; 7:00 AM PST & 1:45 PM PST, respectively)
* Cardiac data from the landmark EPIC trial, demonstrating
significant benefit with Exjade in patients with
transfusion-dependent anemias (ASH Abstract #3873; Monday,
December 8, 2008; 5:30 PM PST). More than 10 additional abstracts
from the EPIC trial in patients with different underlying anemias
will also be presented
* RAD001 data demonstrating benefit in patients with relapsed
and/or refractory Waldenström Macroglobulinemia (ASH Abstract
#1011; Saturday, December 6, 2008; 5:30 - 7:30 PM PST)
* More than 10 abstracts on panobinostat (LBH589), showing early
activity across a broad range of cancers, including acute myeloid
leukemia, cutaneous t-cell lymphoma, multiple myeloma and mantle
cell lymphoma
The most significant presentations at the CTRC-AACR San Antonio
Breast Cancer Symposium (SABCS) will include:
* New data, presented in an oral session, from major international
BIG 1-98 trial evaluating Femara vs. tamoxifen and the sequencing
of the two therapies show evidence of optimal treatment strategy
for postmenopausal women with breast cancer (SABCS Abstract #13;
Thursday, December 11, 2008; 9:45 - 10:00 AM CST)
* The addition of zoledronic acid to neoadjuvant chemotherapy may
influence pathological response - exploratory evidence for direct
anti-tumor activity in breast cancer (AZURE subgroup analysis)
(SABCS Abstract #5101; Saturday, December 13, 2008; 5:00 - 7:00
PM CST). A total of nine Zometa abstracts, of which six will show
the potential anti-cancer benefits of the therapy
* The latest RAD001 data, including six abstracts, and supporting
the need for additional studies to determine its potential role
in the treatment of breast cancer
Other highlights of data to be presented at ASH include:
Glivec
* A Phase III, Randomized, Open-Label Study of 400 Mg Versus 800 Mg
of Imatinib Mesylate in Patients with Newly Diagnosed, Previously
Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Using Molecular Endpoints: 1-Year Results of TOPS (Tyrosine
Kinase Inhibitor Optimization and Selectivity) Study (ASH
Abstract #335: Monday, December 8, 2008; 12:00 PM PST)
* International Randomized Study of Interferon Versus STI571 (IRIS)
7-Year Follow-up: Sustained Survival, Low Rate of Transformation
and Increased Rate of Major Molecular Response in Patients with
Newly Diagnosed CML-CP Treated with Imatinib (ASH Abstract #186:
Monday, December 8, 2008; 8:15 AM PST)
Exjade
* Efficacy and Safety of Deferasirox (Exjade®) in Patients with
Transfusion-Dependent Anemias: 1-Year Results from the Large,
Prospective, Multicenter EPIC Study. (ASH Abstract #3875; Monday,
December 8, 2008; 5:00 PM PST)
* Efficacy and Safety of Deferasirox (Exjade®) during 1 Year of
Treatment in Transfusion-Dependent Patients with Myelodysplastic
Syndromes: Results from EPIC Trial (ASH Abstract #633 - Monday,
December 8, 2008; 3:30 PM PST)
LBH589 (panobinostat)
* Phase II trial of Oral Panobinostat (LBH589) in Patients with
Refractory Cutaneous T-Cell Lymphoma (ASH Abstract #1005 -
Saturday, December 6, 2008; 5:30 PM PST)
* Phase IA/II Study of Oral Panobinostat (LBH589), a Novel
Pan-Deacetylase Inhibitor (DACi) Demonstrating Efficacy in
Patients with Advanced Hematologic Malignancies (ASH Abstract
#958 - Saturday, December 6, 2008; 5:30 PM PST)
* A Phase II Study of Oral Panobinostat (LBH589) in Adult Patients
with Advanced Refractory Multiple Myeloma (ASH Abstract #2774 -
Sunday, December 7, 2008; 6:00 PM PST)
Other highlights of data to be presented at SABCS include:
RAD001
* Multicenter Phase I clinical trial of daily and weekly RAD001
(everolimus) in combination with vinorelbine and trastuzumab in
HER-2-overexpressing metastatic breast cancer with prior
resistance to trastuzumab (SABCS Abstract #406: Friday, December
12, 2008; 7:00 - 9:00 AM CST)
* RAD001 (everolimus) in combination with weekly paclitaxel and
trastuzumab in patients with HER-2-overexpressing metastatic
breast cancer with prior resistance to trastuzumab: a multicenter
Phase I clinical trial (SABCS Abstract #3119: Friday, December
12, 2008; 5:00 - 7:00 PM CST)
About Glivec
Glivec is approved in more than 90 countries including the US, EU and
Japan for the treatment of all phases of Ph+ CML. Glivec is also
approved in the EU, US and other countries for the treatment of
patients with Kit (CD117)-positive gastrointestinal tumors (GIST),
which cannot be surgically removed and/or have already spread to
other parts of the body (metastasized). In Japan, Glivec is approved
for the treatment of patients with Kit (CD117)-positive GIST. In the
EU, Glivec is also approved for the treatment of adult patients with
newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy and as a single agent for patients with
relapsed or refractory Ph+ ALL. Glivec is also approved for the
treatment of adult patients with unresectable, recurrent and/or
metastatic dermatofibrosarcoma protuberans (DFSP) who are not
eligible for surgery. Glivec is also approved for the treatment of
patients with myelodysplastic/myeloproliferative diseases (MDS/MPD).
Glivec is also approved for hypereosinophilic syndrome and/or chronic
eosinophilic leukemia (HES/CEL).
The effectiveness of Glivec is based on overall hematological and
cytogenetic response rates and progression-free survival in CML, on
hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on
hematological response rates in SM, HES/CEL, on objective response
rates and progression-free survival in unresectable and/or metastatic
GIST, on recurrence free survival in adjuvant GIST, and on objective
response rates in DFSP. Increased survival in controlled trials has
been demonstrated only in newly diagnosed chronic phase CML and GIST.
Not all indications are available in every country.
The majority of patients treated with Glivec in clinical trials
experienced adverse events at some time. Most events were of mild to
moderate grade and treatment discontinuation was not necessary in the
majority of cases.
The safety profile of Glivec was similar in all indications. The most
common side effects included nausea, superficial edema, muscle
cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,
arthralgia, hemorrhage, fatigue, headache, joint pain, cough,
dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid
retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well-tolerated in all of the studies that were
performed, either as monotherapy or in combination with chemotherapy,
with the exception of a transient liver toxicity in the form of
transaminase elevation and hyperbilirubinemia observed when Glivec
was combined with high dose chemotherapy.
Rare/serious adverse reactions include: sepsis, pneumonia,
depression, convulsions, cardiac failure, thrombosis/embolism, ileus,
pancreatitis, hepatic failure, exfoliative dermatitis, angioedema,
Stevens-Johnson syndrome, renal failure, fluid retention, edema
(including brain, eye, pericardium, abdomen and lung), hemorrhage
(including brain, eye, kidney and gastrointestinal tract),
diverticulitis, gastrointestinal perforation, tumor hemorrhage/
necrosis, hip osteonecrosis/avascular necrosis.
Patients with cardiac disease or risk factors for cardiac failure
should be monitored carefully and any patient with signs or symptoms
consistent with cardiac failure should be evaluated and treated.
Cardiac screening should be considered in patients with HES/CEL, and
patients with MDS/MPD with high level of eosinophils (echocardiogram,
serum troponin level).
Glivec is contraindicated in patients with known hypersensitivity to
imatinib or any of its excipients. Women of childbearing potential
should be advised to avoid becoming pregnant while taking Glivec.
About Tasigna
In countries where it is approved, Tasigna is indicated for the
treatment of chronic phase and accelerated phase Philadelphia
chromosome-positive chronic myelogenous leukemia in adult patients
resistant or intolerant to at least one prior therapy including
Glivec. The effectiveness of Tasigna is based on confirmed
hematologic and unconfirmed cytogenetic response rates. There are no
controlled trials demonstrating a clinical benefit, such as
improvement in disease-related symptoms or increased survival.
Because taking Tasigna with food may increase the amount of drug in
the blood, Tasigna should not be taken with food and patients should
wait at least two hours after a meal before taking Tasigna. In
addition, no food should be consumed for at least one hour after the
dose is taken.
The most frequent Grade 3 or 4 adverse events for Tasigna were
primarily hematological in nature and included neutropenia and
thrombocytopenia. Elevations were seen in bilirubin, liver function
tests, lipase enzymes and blood sugar, which were mostly transient
and resolved over time. These cases were easily managed and rarely
led to discontinuation. Pancreatitis was reported in less than 1% of
cases. The most frequent non-hematologic drug-related adverse events
were rash, pruritus, nausea, fatigue, headache, constipation, and
diarrhea. Most of these adverse events were mild to moderate in
severity.
Tasigna should be used with caution in patients with uncontrolled or
significant cardiac disease (e.g., recent heart attack, congestive
heart failure, unstable angina or clinically significant
bradycardia), as well as in patients who have or may develop
prolongation of QTc. These include patients with abnormally low
potassium or magnesium levels, patients with congenital long QT
syndrome, patients taking anti-arrhythmic medicines or other drugs
that may lead to QT prolongation. Low levels of potassium or
magnesium must be corrected prior to Tasigna administration. Close
monitoring for an effect on the QTc interval is advisable and a
baseline ECG is recommended prior to initiating therapy with Tasigna
and as clinically indicated.
About Exjade
Exjade is indicated for the treatment of chronic iron overload due to
blood transfusions (transfusional hemosiderosis) in adult and
pediatric patients (aged 2 years and over). It is approved in 90
countries including the US, Switzerland, Japan and the countries
comprising the European Union. The approved indication may vary
depending upon the individual country.
Exjade is contraindicated in patients with hypersensitivity to the
active substance or to any of the excipients.
There have been post-marketing reports of acute renal failure,
hepatic failure and cytopenias in patients treated with Exjade.
Monthly monitoring of serum creatinine, proteinuria, serum
transaminases and blood counts is recommended, and the dose of Exjade
should be modified or interrupted if necessary. More frequent
creatinine monitoring is recommended in patients with an increased
risk of renal complications. Upper gastrointestinal ulceration and
hemorrhage have been reported and caution should be exercised when
combined with drugs with ulcerogenic potential. Skin rashes,
including hypersensitivity reactions, have been reported. Exjade
should be interrupted if severe rash develops and discontinued if
severe hypersensitivity reaction occurs. Auditory and ophthalmic
testing should be conducted annually.
Exjade should not be taken with aluminium-containing antacids.
Caution should be exercised when Exjade is combined with drugs
metabolized through CYP3A4.
The most common adverse reactions are nausea, vomiting, diarrhea,
abdominal pain, rash, non-progressive increase in serum creatinine,
increased transaminases, abdominal distension, constipation,
dyspepsia, proteinuria and headache.
Please visit www.exjade.com for more information.
About Femara
Femara is a leading once-daily oral aromatase inhibitor available in
more than 100 countries, including the US, major European countries
and Japan. It is approved for a number of indications:
* Adjuvant treatment of postmenopausal women with
hormone-receptor-positive early breast cancer
* Extended adjuvant treatment of hormone-dependent early breast
cancer in postmenopausal women who have had prior standard
adjuvant tamoxifen therapy for five years
* First-line treatment in postmenopausal women with
hormone-dependent advanced breast cancer
* Advanced breast cancer in women with natural or artificially
induced postmenopausal status after relapse or disease
progression who have been treated with antiestrogens
* Pre-operative therapy in postmenopausal women with localized
hormone receptor-positive breast cancer which allows subsequent
breast-conserving surgery in patients not originally considered
suitable for this type of surgery
Not all indications are available in every country. Subsequent
treatment after surgery should be in accordance with the standard of
care.
Femara should not be taken by women who have previously had any
unusual or allergic reactions to letrozole or any of its ingredients.
Femara should not be taken by women who are pregnant or
breastfeeding. Only women who are of postmenopausal endocrine status
should take Femara. Patients with severe liver impairment should be
monitored closely. The use of Femara in patients with significantly
impaired kidney function warrants careful consideration.
The most common side effects of Femara are hot flushes, fatigue,
joint pain and nausea. Other common side effects are anorexia,
appetite increase, peripheral edema, headache, dizziness, vomiting,
dyspepsia, constipation, diarrhea, hair loss, increased sweating,
rash, muscle pain, bone pain, arthritis, osteoporosis, bone
fractures, weight increase, hypercholesterolemia and depression.
Other rare, but potentially serious adverse events include
leukopenia, cataract, cerebrovascular accident or infarction,
thrombophlebitis, pulmonary embolism, arterial thrombosis and
ischemic cardiovascular disease.
About Zometa
Zometa is indicated for the treatment of prevention of skeletal
related events (pathological fractures, spinal compression, radiation
or surgery to bone, or tumor-induced hypercalcemia) in patients with
advanced malignancies involving bone. Zometa is approved and
indicated for the treatment of patients with multiple myeloma and
patients with documented bone metastases from solid tumors, in
conjunction with standard antineoplastic therapy. An intravenous
bisphosphonate, Zometa is the only therapy to demonstrate efficacy in
reducing or delaying bone complications across a broad range of tumor
types such as breast, prostate, lung and renal cell cancers in
patients with metastatic disease when administered monthly. Zometa
offers patients, nurses and clinicians a convenient 4 mg, 15-minute
infusion.
In clinical studies, the safety profile with Zometa was similar to
that of pamidronate. Zometa has been associated with reports of renal
insufficiency. Patients should have serum creatinine assessed prior
to receiving each dose of Zometa. Caution is advised when Zometa is
used in aspirin-sensitive patients, or with aminoglycosides, loop
diuretics and other potentially nephrotoxic drugs. Due to the risk
of clinically significant deterioration in renal function, single
doses of Zometa should not exceed 4 mg and the duration of infusion
should be no less than 15 minutes in 100 ml of dilutent.
In clinical trials in patients with bone metastases and hypercalcemia
of malignancy (HCM), Zometa had a safety profile similar to other
intravenous bisphosphonates. The most commonly reported adverse
events included flu-like syndrome (fever, arthralgias, myalgias,
skeletal pain), fatigue, gastrointestinal reactions, anemia,
weakness, cough, dyspnea and edema. Zometa should not be used during
pregnancy. Zometa is contraindicated in patients with clinically
significant hypersensitivity to zoledronic acid or other
bisphosphonates, or any of the excipients in the formulation of
Zometa.
Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients
with cancer receiving treatment including bisphosphonates,
chemotherapy and/or corticosteroids. The majority of reported cases
have been associated with dental procedures such as tooth extraction.
A dental examination with appropriate preventive dentistry should be
considered prior to treatment with bisphosphonates in patients with
concomitant risk factors. While on treatment, these patients should
avoid invasive dental procedures if possible. No data are available
to suggest whether discontinuation of bisphosphonate therapy reduces
the risk of ONJ in patients requiring dental procedures.
Please see full Prescribing Information.
About RAD001
RAD001, an oral once-daily inhibitor of mTOR, is an investigational
drug being studied in multiple tumor types. In cancer cells, RAD001
provides continuous inhibition of mTOR, a protein that acts as a
central regulator of tumor cell division, cell metabolism and blood
vessel growth.
The safety and efficacy profile of RAD001 has not yet been
established in oncology and there is no guarantee that RAD001 will
become commercially available for oncology indications. The active
ingredient in RAD001 is everolimus, which is available in different
dosage strengths under the trade name Certican® for the prevention of
organ rejection in heart and kidney transplant recipients. Certican
was first approved in the EU in 2003.
RAD001 is being evaluated as a single agent or in combination with
existing therapies for renal cell carcinoma, neuroendocrine tumors,
lymphoma, breast, gastric, lung and other cancers, as well as
tuberous sclerosis.
About LBH589 (panobinostat)
Panobinostat (LBH589), is an investigational pan-deacetylase (DAC)
inhibitor which interferes with many of the pathophysiological
mechanisms involved in cancer. Specifically, panobinostat causes an
increased acetylation of both histone and non-histone proteins which
are implicated in oncogenesis and thereby modulates their activity.
In this way, panobinostat selectively induces the death of tumor
cells. To date, objective clinical responses in patients with
hematologic and solid malignancies have been observed with
panobinostat.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "pipeline," "to be,"
"to show," "can," "to report," "to affirm," "will," "may," or similar
expressions, or by express or implied discussions regarding potential
new products, potential new indications for existing products, or
regarding potential future revenues from any such products. You
should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that any new products will be approved for sale in any
market, or that any new indications will be approved for existing
products in any market, or that such products will achieve any
particular revenue levels. In particular, management's expectations
could be affected by, among other things, unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's
ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; government,
industry and general public pricing pressures; the impact that the
foregoing factors could have on the values attributed to the Novartis
Group's assets and liabilities as recorded in the Group's
consolidated balance sheet, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis AG provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2007, the
Group's continuing operations (excluding divestments in 2007)
achieved net sales of USD 38.1 billion and net income of USD 6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 97,000 full-time associates and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
# # #
Novartis Media Relations
Central media line : +41 61 324
2200
Eric Althoff Geoffrey Cook
Novartis Global Media Relations Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862 778 2675 (direct)
+41 79 593 4202 (mobile) +1 973 652 7927(mobile)
eric.althoff@novartis.com geoffrey.cook@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324
7944
Ruth Metzler-Arnold +41 61 324 North America:
9980
Pierre-Michel +41 61 324 Richard Jarvis +1 212 830 2433
Bringer 1065
John Gilardi +41 61 324 Jill Pozarek +1 212 830 2445
3018
Thomas +41 61 324 Edwin Valeriano +1 212 830 2456
Hungerbuehler 8425
Isabella Zinck +41 61 324
7188
e-mail: e-mail:
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--- End of Message ---
Novartis International AG
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WKN: 904278; ISIN:
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