SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K for the month of February 2002
Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
-------------
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant
files or will fill annual reports under cover of
Form 20-F or Form 40-F.
Form 20 F X Form 40-F _
-
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Section Exchange Act of 1934.
Yes __ No X
-
Enclosures:
1. New England Journal of Medicine data demonstrate improved CML response rates
with Glivec(R)(February 28, 2002)
2. Data recently published in New England Journal of Medicine demonstrates
zoledronic acid dosed once yearly is effective in increasing bone mineral
density in post menopausal women with osteoporosis (February 28, 2002)
3. Eczema improves in 82% of adults treated with Novartis' new non-steroid,
Elidel(R)Cream (February 25, 2002)
4. FDA approves Novartis drug Zometa(R)for the treatment of cancer-related bone
complications (February 22, 2002)
5. Novartis breakthrough drug Glivec(R)receives positive opinion from CPMP for
treatment of a rare, life-threatening GI cancer; moves closer to EU approval
(February 22, 2002)
6. Novartis Venture Fund extends its strategic and geographic reach (February
21, 2002)
7. Dainippon licenses new potential Anxiety treatment to Novartis (February 12,
2002)
8. FDA approves Novartis drug Glivec(R)for a life-threatening GI cancer
(February 1, 2002)
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
New England Journal of Medicine data demonstrate improved
CML response rates with Glivec(R)
An increasing number of patients in chronic phase (earlier phase) are achieving
durable cytogenetic responses
Basel, 28 February 2002 - Glivec(R) (imatinib) induces higher haematologic and
cytogenetic response rates than previously reported in patients in the chronic
phase (first phase) of chronic myeloid leukemia (CML) who have been
unsuccessfully treated with interferon-alpha, according to updated data from a
pivotal Phase II study. The new data, based on a median follow-up of 18 months,
indicate that overall response rates to the Novartis drug increased in CML
patients taking the drug early in their disease. These data, an update of the
12-month results presented at the meeting of the American Society of Haematology
(ASH) in December 2001, are published for the first time in today's issue of The
New England Journal of Medicine (NEJM).
"The data on Glivec in chronic phase CML are very exciting because they are
getting continually stronger," said Hagop Kantarjian, MD, Professor of Medicine,
Chairman, Department of Leukemia and Chief, Section of Leukemia Developmental
Therapeutics, M.D. Anderson Cancer Centre, Houston, Texas, lead study
investigator. "These results are extremely promising. They suggest that earlier
use of Glivec could have a major impact in improving patients' long-term
outcome."
Study Details
The Philadelphia chromosome (Ph) is the genetic abnormality that characterises
CML in most patients. Complete cytogenetic response, the elimination of the
Philadelphia chromosome, is regarded as the ultimate goal of CML treatment.
The NEJM report features 18-month data on 454 evaluable patients with chronic
phase CML who had failed prior therapy with interferon-alpha. The estimated
progression-free survival rate at 18-months was 89%. The data demonstrated that
41% of patients (188/454) achieved a complete cytogenetic response (Ph+ cells
0%) and 60% (272/454) achieved a major cytogenetic response (Ph+ cells < 35%).
Of the patients who achieved a major cytogenetic response, 84% (228/272) were
still maintaining that response at the time of follow-up. The achievement of a
cytogenetic response at three months was associated with an improved
progression-free survival rate. In addition, 95% of patients (430/454) achieved
a complete haematologic response (normalisation of blood counts).
The cytogenetic response rates reported, as well as the estimated 18-month
progression-free survival rate, are higher than those historically documented
with other CML therapies,
Page 2 of total 24 pages
including interferon-alpha (5-7% complete cytogenetic response) and
homoharringtonine (HHT) alone or in combination with low-dose cytarabine
(Ara-C). Although there are no long-term data to provide clinical results
regarding survival rates for CML patients taking Glivec, researchers believe
that durable complete or major cytogenetic response rates improve the potential
for longer-term survival.
* Outside the U.S: Glivec(R)(imatinib); in the U.S.: Gleevec(TM)(imatinib
mesylate)
"Novartis is very pleased that we continue to see increasing response rates to
Glivec," said David Parkinson, MD, Vice President, Clinical Research, Novartis
Oncology. "Longer-term follow-up demonstrating higher cytogenetic response rates
to Glivec provides valuable insight into the overall efficacy of the drug and
how this relates to longer-term survival with Glivec."
In most countries where Glivec is approved, it is indicated for the treatment of
patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase,
or in chronic phase after failure of interferon-alpha therapy. The effectiveness
of Glivec is based on overall haematologic and cytogenetic response rates. There
are no controlled trials demonstrating a clinical benefit, such as improvement
in disease-related symptoms or increased survival.
Contraindications and Adverse Events
In this study, adverse events were similar to those previously reported. The
majority of patients treated with Glivec experienced adverse events at some
time. Most events are of mild to moderate grade, but in clinical trials the drug
was discontinued for adverse events in 1% of patients in chronic phase, 2% in
accelerated phase and 5% in blast crisis. Women of childbearing potential should
be advised to avoid becoming pregnant while taking Glivec. The most common side
effects included nausea, fluid retention, vomiting, diarrhoea, haemorrhage,
muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnoea, as well as
neutropenia and thrombocytopenia. Serious and severe side effects, such as
hepatotoxicity (1.1% to 3.5%), fluid retention syndrome (2% to 10%), neutropenia
(8% to 46%) and thrombocytopenia (less than 1% to 31%) have also been reported
in some patients. There are no long-term safety data on Glivec treatment
available up to now.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "believe that durable complete or major cytogenetic
response rates improve the potential," "continually stronger," "induces higher,"
"could have a major impact," "indicate that response rates to the Novartis drug
are being maintained," and "suggest that earlier use" or similar expressions.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors that may cause actual results with Glivec to be materially
different from any future results, performance or achievements expressed or
implied by such statements. In particular, management's ability to ensure
satisfaction of the FDA's further requirements is not guaranteed and
management's expectations regarding further commercialisation of Glivec could be
affected by, among other things, additional analysis of data; new data;
unexpected clinical trial results; 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; and other risks and factors referred to in the Company's current Form
20-F on file with the Securities and Exchange Commission of the United States.
Should one or more of these risks or uncertainties materialise, or should
underlying assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected.
Page 3 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 4 of total 24 pages
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
Data recently published in New England Journal of Medicine demonstrates
zoledronic acid dosed once yearly is effective in increasing bone mineral
density in post menopausal women with osteoporosis
A once a year dose of intravenous bisphosphonate significantly increases bone
mass in the spine and hip in women with post menopausal osteoporosis
Basel, 28 February 2002 - A study published today in The New England Journal of
Medicine (NEJM) demonstrates that the Novartis drug zoledronic acid, a new
intravenous bisphosphonate, significantly increases bone density in women with
postmenopausal osteoporosis. This is the first time that a bisphosphonate, given
at intervals of up to one year between doses, produces sustained suppression of
bone turnover and an increase in bone mineral density in the spine and hip as
great as that seen with oral daily dosing of other bisphosphonates.
"An effective therapy that offers the convenience of once yearly dosing would
represent a major advance in treatment," said Ian R. Reid, MD, Professor of
Medicine and Endocrinology at the University of Auckland, New Zealand, and
principal investigator of the study. He added "These findings are good news for
patients and physicians alike as oral bisphosphonates, although effective in
treating osteoporosis, are known to cause gastrointestinal side effects that
often lead to compliance problems."
This dose-finding study, conducted in 351 women at 25 centres in 10 countries,
showed treatment with zoledronic acid resulted in bone mineral density increases
comparable to those produced with oral daily or weekly dosing of other
bisphosphonates.
The women in this randomised, controlled, Phase II study were given a placebo or
one of five different doses of zoledronic acid intravenously at different dosage
intervals. Some participants were given 0.25 mg, 0.5 mg or 1 mg every three
months. Another group received 2 mg at the onset of the study and again at six
months. The remaining group received a single 4 mg dose at the start of the
study. At the end of 12 months, bone mineral density was significantly increased
from placebo in all dosing groups. In addition, important biochemical markers of
bone degradation were significantly and continually suppressed as soon as one
month and throughout the 12-month period. The treatment was generally safe and
well tolerated. In particular, zoledronic acid was not associated with GI side
effects that have been observed with oral bisphosphonates. Only some myalgia
(muscle pain) and fever occurred more commonly in the treatment groups at the
time of injection.
Page 5 of total 24 pages
"Novartis has a long history in the discovery and development of safe and
effective treatments for osteoporosis," said Thomas Ebeling, CEO of Novartis
Pharma AG. "These data show that zoledronic acid offers great potential in
revolutionizing the treatment of this debilitating disease."
Novartis has recently embarked on an extensive Phase III study program known as
HORIZON to determine the efficacy of zoledronic acid in reducing the risk of
osteoporotic fractures and as a treatment for Paget's disease. HORIZON (Health
Outcomes & Reduced Incidence with Zoledronic Once Yearly) will be one of the
largest osteoporotic clinical programs undertaken. All studies will involve a
single dose of 5mg zoledronic acid once a year.
Osteoporosis is a worldwide epidemic. According to the National Osteoporosis
Foundation, the condition represents a major health threat to almost 44 million
U.S. women and men, aged 50 and older, representing 55% of the population in
this age group. By the year 2010, it is estimated that more than 52 million
women and men in this same age category will be affected and, if current trends
continue, the figure will climb to more than 61 million by 2020. The
International Osteoporosis Foundation estimates that one out of every eight
Europeans age 50 or older will suffer a bone fracture during their lifetime
caused by osteoporosis. The annual incidence of hip fractures in the European
Union is expected to double from 414,000 to 972,000 over the next 50 years.
Zoledronic acid is a new generation intravenous (IV) bisphosphonate. Novartis
received its initial marketing clearance for zoledronic acid, under the brand
name Zometa(R), in the treatment of hypercalcaemia of malignancy (HCM), also
known as tumour-induced hypercalcaemia (TIH), in the United States, European
Union and more than 65 other countries, including Switzerland, Brazil, Canada
and Australia.
On 22 February 2002, Zoledronic acid, under the brand name Zometa was approved
by the US Food and Drug Administration (FDA) for the treatment of patients with
multiple myeloma and patients with documented bone metastases from solid
tumours, in conjunction with standard antineoplastic therapy. These solid
tumours include prostate cancer, lung cancer, breast cancer, and other solid
tumour types.
This release contains certain forward-looking statements relating to the
Company's business, which can be identified by the use of forward-looking
terminology such as "would represent," "good news," "offers great potential,"
"significantly increases," "to determine the efficacy," "will involve" or
similar expressions, or by discussions of strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause actual results with zoledronic acid to be
materially different from any future results, performance or achievements
expressed or implied by such statements. Some of these are uncertainties
relating to unexpected regulatory delays, further clinical trial results
regarding efficacy or safety of zoledronic acid, government regulation or
competition in general, as well as factors discussed in the Company's Form 20F
filed 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 described herein as
anticipated, believed, estimated or expected.
Page 6 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 7 of total 24 pages
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
Eczema improves in 82% of adults treated with Novartis' new
non-steroid, Elidel(R) Cream
Basel, 25 February 2002 - Four out of five adults with the itching skin disease,
atopic eczema, experienced improvement of their condition with a new treatment
based on the non-steroid cream, Elidel(R) (pimecrolimus), according to study
results released today. The study, presented at the annual meeting of the
American Academy of Dermatology in New Orleans, USA, also showed that seven out
of ten adults were considered by their doctors to have been successfully treated
with the cream-based regimen, and the itching associated with eczema began to
ease on average within two days of starting Elidel.
The results build on the efficacy seen with younger patients. In previous
studies, itching was relieved within one week in up to 70% of babies aged 3 - 23
months treated with Elidel. Seven out of ten babies, and 61% of children aged 2
- 17 years, had their eczema under control over six months without any steroids,
by using Elidel at the first signs of disease - such as redness and swelling -
or itching.
"Itching is the most bothersome symptom of this disease and patients are looking
for quick relief," said the study's lead investigator, Professor Michael Meurer,
Professor of Dermatology at the University of Dresden, Germany. "In addition,
many patients would like treatments that are free of the steroids we currently
prescribe, because they fear the side effects associated with long-term steroid
use, such as skin thinning. For the last half-century, we have really had
nothing else to offer. I am sure those patients, and physicians, who do not like
to use steroids will welcome the new generation of topical therapies such as
Elidel because they do not contain steroids and are free of steroid
side-effects."
Discovered and developed by Novartis, Elidel was approved last December by the
US Food and Drug Administration for the short-term and intermittent long-term
treatment of mild to moderate atopic dermatitis in patients aged two years and
older in whom conventional therapies are inadvisable. Applications for marketing
approvals are under consideration in Canada, Switzerland and Denmark (the
reference member state for the European Union).
In the German multi-centre study reported by Professor Meurer, half of the 192
participating adults with moderate to severe disease were treated with an
Elidel-based regimen, consisting of emollients (moisturisers) for dry skin and
Elidel applied twice daily from the first sign or symptom of eczema until the
skin cleared. In cases where the eczema was not controlled and flared - worsened
to the stage that it was unacceptable to the patient - topical steroids were
used. The control group was treated with a regimen representing the current
standard eczema therapy - emollients, with a
Page 8 of total 24 pages
vehicle cream containing no drug being applied at the first sign or symptom, and
topical steroids for disease flares.
In the Elidel group, 82% of patients experienced improvement in their condition
over the six months, according to their doctor, but only 51% did so in the group
receiving the equivalent of current steroid-based therapy. By the end of the
study, 69% of patients were considered by their doctors to have been
successfully treated with the Elidel-based regimen, compared with 37% in the
control group - although 49% of Elidel-treated patients did not use any
steroids, compared with 22% in the control group. While itching began to ease
within two days of starting treatment in the Elidel group, it worsened in the
control group.
The most commonly reported drug-related adverse event was application site
warmth or burning, occurring in 15% of Elidel-treated patients and in 5% of the
control group; this usually resolved within 1 to 7 days in the Elidel-treated
patients, and in 1-9 days in the control group. Other data presented at the AAD
congress showed the incidence of application site burning with Elidel is much
lower than the 34-43% reported in pediatric patients treated with another new
non-steroid treatment.
There is no cure for eczema and its causes are unknown, although patients often
have a family history of eczema, hay fever and/or asthma. Affecting
approximately 20% of the population at some time in their life, eczema usually
begins in childhood and may last until the late teenage years or even for life.
In the study, Elidel was used as soon as the first signs and symptoms appear, to
prevent the condition worsening, enabling steroids to be reserved for short-term
treatment if the disease is severe. Elidel is a skin-selective inflammatory
cytokine inhibitor and works by selectively targeting T-cells in the skin,
stopping them producing the cytokines which cause the inflammation, redness and
itching associated with atopic eczema (also known as atopic dermatitis).
This press release contains certain forward-looking statements, relating to the
Company's business, which can be identified by the use of forward-looking
terminology such as "would like," "build on," "new treatments" or similar
expressions, or by discussions of strategy, plans or intentions. Such statements
include descriptions of the potential benefit of Elidel (pimecrolimus) Cream 1%
as evidenced by clinical trial results and FDA approval. Those statements
reflect the current views of the Company with respect to future events and are
subject to certain risks, uncertainties and assumptions. Many factors could
cause the actual results, performance or achievements of the Company to be
materially different from any future results, performances or achievements that
may be expressed or implied by such forward-looking statements. There are no
guarantees that the aforementioned events will result in the commercial success
of Elidel (pimecrolimus) Cream 1% in any market. Any such commercial success can
be affected by, among other things, uncertainties relating to product
development, adverse results in clinical trials, regulatory actions or delays or
government regulation generally, the ability to obtain or maintain patent or
other proprietary intellectual property protection, competition in general and
other risks and factors referred to in the Company's current Form 20-F on file
with the Securities and Exchange Commission of the United States.
Page 9 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 10 of total 24 pages
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
FDA approves Novartis drug Zometa(R)for the treatment of cancer-related bone
complications
First bisphosphonate proven effective for the treatment of bone metastases in
patients with prostate cancer, lung cancer and other solid tumors; Zometa is
approved for second indication in six months
Basel, 22 February 2002 - The US Food and Drug Administration (FDA) today
approved the Novartis drug Zometa(R) (zoledronic acid) for the treatment of
patients with multiple myeloma and patients with documented bone metastases from
solid tumors, in conjunction with standard antineoplastic therapy. These solid
tumors include prostate cancer, lung cancer, breast cancer and other solid tumor
types. In prostate cancer, patients should have progressed after treatment with
at least one hormonal therapy. The trials that led to the approval of Zometa
mark the first time any bisphosphonate has demonstrated efficacy in treating
bone complications in patients with prostate cancer, lung cancer and other solid
tumors. Further, Zometa offers patients, nurses and clinicians a convenient 4
mg, 15-minute infusion time.
"At Novartis we are committed to developing innovative and practical new
treatments for patients with cancer," said David Epstein, President, Novartis
Oncology. "With this approval, Zometa offers to physicians and patients a new,
broadly effective and convenient treatment for the debilitating bone
complications of cancer."
Novartis submitted the new drug application (NDA) for the use of Zometa in the
bone metastases indication to the FDA on 22 August 2001 and on 23 October 2001
the NDA received a priority review designation. Submission to the EMEA in the
European Union was made on 30 July 2001.
Clinical data
The approval for Zometa is based on data from three large international clinical
trials evaluating more than 3,000 patients with prostate cancer, lung cancer and
other solid tumors, breast cancer and multiple myeloma. This is the largest set
of clinical trials ever conducted to evaluate the efficacy and tolerability of a
bisphosphonate in treating the complications associated with cancerous bone
lesions.
Page 11 of total 24 pages
Clinical trials demonstrated that zoledronic acid decreases the skeletal
complications of patients with multiple myeloma and of patients with metastases
from solid tumors. In two placebo-controlled clinical studies in patients with
bone metastases from prostate cancer or from other solid tumors, both the number
of patients with skeletal events and the time to first skeletal related event
were decreased relative to placebo.
Breast cancer, lung cancer, prostate cancer, and many other types of solid
tumors often spread (metastasize) to bones, while multiple myeloma is a type of
cancer that starts in bones. These cancerous bone lesions can cause a variety of
complications that seriously affect a patient's life, such as pain, fractures,
and/or a need for surgery or radiation therapy.
"Advanced cancers commonly spread to bone and cause a variety of complications
that can significantly impact a patient's day-to-day activities," said Matthew
Smith, MD, Ph.D., Assistant Professor of Medicine, Harvard Medical School,
Massachusetts General Hospital. "There is an unmet clinical need to address
these complications, especially in patients with prostate cancer, which makes
Zometa an important addition to the current standard treatments for men with
advanced prostate cancer."
About Zometa
Zometa is a new generation intravenous (IV) bisphosphonate. Novartis initially
received marketing clearance for Zometa in the treatment of hypercalcemia of
malignancy (HCM), also known as tumor-induced hypercalcemia (TIH), in the
European Union and more than 60 countries, including the United States,
Switzerland, Brazil, Canada and Australia.
Contraindications and adverse events
Zometa, and other bisphosphonates, have 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 administered with other
potentially nephrotoxic drugs. Doses of Zometa should not exceed 4 mg and the
duration of infusion should be no less than 15 minutes.
In clinical trials in patients with bone metastases, Zometa was generally well
tolerated, with a safety profile similar to other bisphosphonates. The most
commonly reported adverse events included flu-like syndrome (fever, arthralgias,
myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness,
cough, dyspnoea and edema. Occasionally, patients experienced electrolyte and
mineral disturbances, such as low serum phosphate, calcium, magnesium and
potassium. 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.
This release contains certain forward-looking statements relating to the
Company's business, which can be identified by the use of forward-looking
terminology such as "mark the first time," "offers," "innovative," "new
treatments," "important addition," and "significantly impact" or similar
expressions, or by discussions of strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause actual results with Zometa to be materially
different from any future results, performance or achievements expressed or
implied by such statements. Some of these are uncertainties relating to
unexpected regulatory delays, further clinical trial results regarding efficacy
or safety of Zometa, government regulation or competition in general, as well as
factors discussed in the Company's Form 20F filed with the 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 described herein as anticipated, believed,
estimated or expected.
Page 12 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 13 of total 24 pages
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
Novartis breakthrough drug Glivec(R) receives positive opinion from CPMP for
treatment of a rare, life-threatening GI cancer; moves closer to EU approval
Glivec - discovered and developed by Novartis - offers unprecedented efficacy in
inoperable gastrointestinal stromal tumors (GISTs)
Basel, 22 February 2002 - Novartis announced today that it has received a
positive opinion from the Committee for Proprietary Medicinal Products (CPMP)
for the novel agent Glivec(R) (imatinib)1 in the treatment of adult patients
with Kit (CD 117) positive unresectable (inoperable) and/or metastatic malignant
gastrointestinal stromal tumors (GISTs). Prior to the development of Glivec,
patients with GISTs had no effective treatment options beyond surgery. The
European Union (EU) Commission usually grants approval of products four months
after a CPMP positive opinion. Glivec was designated orphan drug status in
November 2001.
Glivec was approved in the EU on 7 November 2001 for its initial indication for
the treatment of Philadelphia chromosome (bcr-abl) positive chronic myeloid
leukemia (CML) in chronic phase after failure of interferon-alpha therapy, or in
accelerated phase or blast crisis.
"Novartis is extremely gratified that Glivec, which has already benefited
thousands of patients worldwide with CML, is now one step closer to becoming
readily available in the European Union to patients with GISTs," said David
Epstein, President, Novartis Oncology.
GISTs are the most common malignant form of sarcoma that arise in the
gastrointestinal tract. Worldwide, there are approximately 12,000 new cases each
year. The incidence is highest in people 30-60 years of age. Historically, GISTs
have been very difficult to treat due to their high levels of resistance to
treatment with traditional chemotherapy and radiation therapy. For patients with
metastatic or unresectable disease, GISTs had represented an incurable
malignancy with a median survival of approximately 10 to 12 months. Until now,
surgery has been the only effective treatment option, resulting essentially in
palliation of the disease.
-----------------------
1 Outside the US: Glivec(R) (imatinib); in the US: GleevecTM (imatinib mesylate)
Page 14 of total 24 pages
About Glivec and GISTs
The CPMP positive opinion for the GIST indication is supported by data from an
open-label, multinational study conducted in 147 patients with unresectable or
metastatic malignant GISTs. Patients were randomized to receive either 400 mg or
600 mg of Glivec daily for up to 24 months. The overall response rate was 40%,
based on confirmed partial responses at the time of the data cut-off for the
submission.
Glivec, a signal transduction inhibitor, is one of the first cancer drugs to be
developed using rational drug design, based on an understanding of how some
cancer cells work. Glivec targets the activity of certain enzymes called
tyrosine kinases that play an important role within certain cancer cells. The
activity of one of these tyrosine kinases, known as c-kit, is thought to drive
the growth and division of most GISTs.
Glivec to date
The US Food and Drug Administration (FDA) was the first to approve Glivec for
the GIST indication, for which it was designated as an Orphan Drug, on 1
February 2002. Novartis also has submitted a supplemental filing application for
Glivec to health authorities in Switzerland for the GIST indication. To date,
Novartis has received marketing clearance for Glivec for the CML indication in
the European Union and more than 60 countries, including the United States,
Switzerland and Japan. In the treatment of CML, it is designated as an Orphan
Drug in the United States, European Union and Japan.
Contraindications and adverse events
Although the majority of patients had adverse events reported at least once
during the trial, most events were mild to moderate in severity. In the GIST
trial, drug was discontinued for adverse events in six patients (8%) in both
dose levels studied. In this clinical trial, the most common adverse events were
edema, nausea, diarrhea, abdominal pain, muscle cramps, fatigue and rash. In
this trial, seven patients (5%) were reported to have gastrointestinal bleeds
and/or intratumoural bleeds. Gastrointestinal tumor sites may have been the
source of GI bleeds. Glivec is contraindicated in patients with known
hypersensitivity. Women of childbearing potential should be advised to avoid
becoming pregnant while taking Glivec.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "moves closer," "usually grants approval," "until now,"
"one step closer to becoming readily available," or similar expressions. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause actual results with Glivec to be materially
different from any future results, performance or achievements expressed or
implied by such statements. In particular, management's ability to ensure
satisfaction of the FDA's further requirements is not guaranteed and
management's expectations regarding further commercialization of Glivec could be
affected by, among other things, additional analysis of data; new data;
unexpected clinical trial results for Glivec in the IRIS trial or other Glivec
clinical trials; 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; and
other risks and factors referred to in the Company's current Form 20-F on file
with the Securities and Exchange Commission of the United States. 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.
Page 15 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 16 of total 24 pages
Novartis International AG
Novartis Communications
CH-4002 Basel
(Novartis Logo) Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
Novartis Venture Fund extends its strategic and geographic reach
Integration of the Novartis BioVenture Fund strengthens its position in the USA
Basel, 21 February 2002 - In its fifth year, the Novartis Venture Fund extended
its role as an important partner for start-up companies in Switzerland and other
countries, as illustrated in the Activity Report published today. To date, the
Fund has been involved in the establishment of 107 companies and, in 2001, a
further step in its development was taken with the extension of its strategic
and geographic reach. In this strategy, new companies are also to be supported
with venture capital beyond the start-up phase. With the integration of the
Novartis BioVenture Fund, which is most active in the USA, the Novartis Venture
Fund is further extending its field of operations in the important US market.
"With the recent integration of the US-focused Novartis BioVenture Fund, we have
further strengthened the position of the Novartis Venture Fund", said Daniel
Vasella, Chairman and CEO of Novartis. "And in so doing, we are reinforcing the
commitment that we made five years ago - to foster entrepreneurship, to create
new jobs and to promote innovative discoveries."
With the addition of the BioVenture Fund, the Novartis Venture Fund now has
three pillars of activity: the Spin-off Fund will continue to support Novartis
employees who want to set up in business with an innovative idea, while the
Start-up Fund supports young companies emerging from the universities. Thanks to
the successful business operations of some portfolio companies, the Venture Fund
has now seen the first substantial return on its capital. This has allowed the
Fund to continue its activities on the same scale as before. Since the inception
of the Fund in 1996, 94 new companies have been established and 1350 jobs
created, with a total financial support of CHF 126 million.
As its third pillar, the BioVenture Fund, that was recently integrated into the
Novartis Venture Fund, increases not only its geographic reach but also its
financial muscle. The BioVenture Fund is endowed with USD 100 million and has
invested in 13 biotechnology companies, mostly in the USA, whose activities are
contributing to the treatment of diseases and helping to speed up the discovery
and development of medicines.
As part of the new strategy, a growing share of investments will flow into
existing companies which are dependent on additional capital as they continue to
develop their technologies. For example, the Spin-off and Start-up Fund last
year invested a total of CHF 30 million, of which CHF 18 million went into new
companies and CHF 12 million into existing ones.
Page 17 of total 24 pages
"Despite the current recessionary trends in the world today, the Life Sciences
continue to offer unique opportunities for start-up companies," says Francois
L'Eplattenier, Chairman of the Board of the Novartis Venture Fund. "The winners
of tomorrow will be those who best manage collaborations and intelligently
capitalize on synergies with the growing number of smart and diversified niche
players."
The Novartis Venture Fund is built on the belief that economic growth and the
creation of new jobs can be achieved in the long run if new entrepreneurial
initiatives develop and promising ideas become a business reality. With an
initial venture capital of CHF 100 million and USD 100 million, the Novartis
Venture Fund supports new and innovative business projects in forward-looking
areas, especially in the field of Life Sciences and new technologies. Further
information can be found on the internet at http://www.venturefund.novartis.com.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
The Activity Report of the Novartis Venture Fund, which summarizes the
activities of the Fund and presents some examples of newly established
companies, can be ordered from the following address.
Dr. Rudolf Gygax Email:
rudolf.gygax@group.novartis.com
Portfolio- and Business-Manager
Novartis International AG
WSJ-200.225
CH-4002 Basel
Page 18 of total 24 pages
Novartis International AG
Novartis Communications
CH-4002 Basel
(Novartis Logo) Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
Dainippon licenses new potential Anxiety treatment to Novartis
Basel, Switzerland and Osaka, Japan, 12 February 2002 - Novartis Pharma AG and
Dainippon Pharmaceutical Co., Ltd. today announced a license agreement related
to AC-5216, a pre-clinical compound for the treatment of Anxiety.
The number of patients afflicted by one or more of the various Anxiety
disorders, such as Generalized Anxiety Disorder (GAD), Social Anxiety Disorder
(SAD) and Panic Disorder is estimated to be some 90 million patients worldwide
and anti-anxiety treatments represent a growing market currently worth about CHF
8 billion a year.
Under terms of the agreement, Novartis acquires exclusive rights to develop and
commercialize the compound worldwide excluding Japan and certain Asian countries
where Dainippon possesses exclusive rights to develop and commercialize the
compound. Development will be closely co-ordinated between the companies to
allow for optimal registration and approval around the world.
The mitochondrial benzodiazepine receptor ligand AC-5216 belongs to a novel
class of compounds with a mechanism of action distinct from both Benzodiazepines
and Selective Serotonin Re-Uptake Inhibitors (SSRIs). In non-clinical studies,
mitochondrial benzodiazepine receptor ligands have demonstrated a fast onset of
action without the side effects typical of benzodiazepines such as sedation,
muscle relaxation, potentiation of the effects of alcohol, and addiction.
Novartis plans to start phase I trials after completion of certain preparatory
activities.
The foregoing press release contains forward-looking statements that can be
identified by terminology such as "plan", "have demonstrated", "estimated",
"growing" or similar expressions. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors, which may cause the actual
results and assumptions to be materially different from any future results,
performance or achievements expressed or implied by such statements. There are
no guarantees that the license agreement described above will result in the
commercialisation of any product in any market. Any such commercialisation can
be affected by, among other things, uncertainties associated with the
development and manufacturing of the treatment, the conduct and results of
clinical trials, regulatory actions or delays or government regulations
generally, the ability to obtain or maintain patent and other proprietary
intellectual property protection, and competition in general, as well as factors
discussed in Novartis AG's Form 20-F on file, and other filings with the US
Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialise, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated,
believed, estimated or expected.
Page 19 of total 24 pages
Dainippon Pharmaceutical was founded in 1897 as one of the pioneers of the
modern Japanese pharmaceutical industry, strives to contribute to the modern
world economy through its research and businesses in pharmaceuticals, animal
health, food additives, industrial chemicals and research instrumentation.
Dainippon's group consolidated revenues for the year ended March 31, 2001 were
158 billion Japanese Yen (USD 1,281 million). Headquartered in Osaka, Japan,
Dainippon Pharmaceutical's current pharmaceutical R&D is focused on its fields
of expertise in vascular diseases, psycho-neurological diseases,
immuno-inflammatory diseases and infectious diseases. For further information
please consult http://www.dainippon-pharm.co.jp/.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1
billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 71 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 20 of total 24 pages
Investor Relations Novartis International AG
CH-4002 Basel
(Novartis Logo) Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zenter
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
Investor Relations Release
--------------------------------------------------------------------------------
FDA approves Novartis drug Glivec(R)for a life-threatening GI cancer
Glivec - discovered and developed by Novartis - is approved for second
indication in nine months, to treat gastrointestinal stromal tumors (GISTs);
unprecedented efficacy in an inoperable solid tumor
Basel, 1 February 2002 - The US Food and Drug Administration today approved the
Novartis drug Glivec(R) (imatinib)2 for the treatment of patients with Kit (CD
117) positive unresectable (inoperable) and/or metastatic malignant
gastrointestinal stromal tumors (GISTs). The effectiveness of Glivec in GIST is
based on the objective response rate. There are no controlled clinical trials
demonstrating a clinical benefit, such as improvement in disease-related
symptoms or increased survival. Prior to the availability of Glivec, patients
had no effective treatment options beyond surgery.
Glivec was approved in the US on 10 May 2001 for its initial indication as a
treatment for a specific type of leukemia.
According to Dr. Daniel Vasella, Chairman and CEO of Novartis, "Glivec has
already made a major difference in the lives of patients with chronic myeloid
leukemia and we're extremely gratified to now make this drug available to
patients with GIST." Dr. Vasella continued, "Novartis - along with our
colleagues in academia and government - continues to study Glivec and
investigate other cancers in which it may help patients - either alone or in
combination with other therapies."
GISTs are the most common malignant form of sarcoma that arise in the
gastrointestinal tract. Historically, they have been very difficult to treat due
to their high levels of resistance to treatment with traditional chemotherapy
and radiation therapy. For patients with metastatic or unresectable disease,
GISTs had represented an incurable malignancy with a median survival of
approximately 10 to 12 months. Until now, surgery has been the only effective
treatment option, resulting essentially in palliation of the disease. The
limited prevalence of GIST has resulted in the FDA designating Glivec as an
Orphan Drug for this indication.
-----------------------
2 In the US: Gleevec(TM)(imatinib mesylate); outside the US: Glivec(R)(imatinib)
Page 21 of total 24 pages
About Glivec and GISTs
The FDA approval for the GIST indication is supported by data from an
open-label, multinational study conducted in 147 patients with unresectable or
metastatic malignant GISTs. Patients were randomized to receive either 400 mg or
600 mg of Glivec daily for up to 24 months. The overall response rate was 38%
(400 mg = 33%; 600 mg = 43%), based on confirmed partial responses at the time
of the data cut-off for the submission.
Glivec, a signal transduction inhibitor, is one of the first cancer drugs to be
developed using rational drug design, based on an understanding of how some
cancer cells work. Glivec targets the activity of certain enzymes called
tyrosine kinases that play an important role within certain cancer cells. The
activity of one of these tyrosine kinases, known as c-kit, is thought to drive
the growth and division of most GISTs.
Novartis also has submitted a supplemental filing application for Glivec to
health authorities in the European Union and in Switzerland for the GIST
indication.
Glivec To Date
Glivec received US FDA approval for the chronic myeloid leukemia indication
(CML) on 10 May 2001 for the treatment of patients in the blast crisis,
accelerated phase, or in chronic phase after failure of interferon-alpha
therapy. The effectiveness of Glivec in CML is based on overall hematologic and
cytogenetic response rates. As yet, there are no controlled trials demonstrating
a clinical benefit such as improvement in disease related symptoms or increased
survival. For CML, Glivec is currently approved for marketing in the European
Union and in more than 60 countries, including Japan, Switzerland and Australia.
In the treatment of CML, it is designated as an Orphan Drug in the United
States, European Union and Japan.
Contraindications and Adverse Events
Although the majority of patients had adverse events reported at least once
during the trial, most events were mild to moderate in severity. In the GIST
trial, drug was discontinued for adverse events in six patients (8%) in both
dose levels studied. In this clinical trial, the most common adverse events were
edema, nausea, diarrhea, abdominal pain, muscle cramps, fatigue and rash. In
this trial, seven patients (5%) were reported to have gastrointestinal bleeds
and/or intratumoural bleeds. Gastrointestinal tumor sites may have been the
source of GI bleeds. Glivec is contraindicated in patients with known
hypersensitivity. Women of childbearing potential should be advised to avoid
becoming pregnant while taking Glivec.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "major difference," "continues to study," "other
cancers," "encouraging results," "most major advance" and "is supported by," or
similar expressions. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause actual results with Glivec
to be materially different from any future results, performance or achievements
expressed or implied by such statements. In particular, management's ability to
ensure satisfaction of the FDA's further requirements is not guaranteed and
management's expectations regarding commercialization of Glivec could be
affected by, among other things, additional analysis of data; new data;
unexpected clinical trial results; 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; and other risks and factors referred to in the Company's current Form
20-F on file with the Securities and Exchange Commission of the United States.
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.
Page 22 of total 24 pages
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70,000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
# # #
Page 23 of total 24 pages
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Novartis AG
Date: March 5, 2002 By: /s/ RAYMUND BREU
-------------------
Name: Raymund Breu
Title: Chief Financial Officer
Page 24 of total 24 pages