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 March 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 file 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 Securities Exchange Act of 1934.
Yes __ No X
Enclosures:
1. Novartis licenses Everolimus, the active ingredient in Certican TM, to
Guidant for use in drug eluting stents (March 28, 2001)
2 Novartis Consumer Health and Kao have agreed to end joint venture in
Japan (March 26, 2002)
3. British study highlights women prefer Femara(R)in advanced breast cancer
trial (March 20, 2002)
Page 1 of 30
4. Diovan(R)reduced mortality by 33 per cent in heart failure patients who
did not take ACE inhibitors (March 19, 2002)
5. Landmark clinical trial demonstrates Lescol(R)protects against future
fatal and non-fatal cardiac events (March 19, 2002)
6. Two further marketing approvals for Zelnorm(TM)/Zelmac(R)(March 19,
2002)
7. Novartis' new non-steroid eczema treatment, Elidel(R)cream, approved for
use in babies to adults in Denmark (March 18, 2002)
8. New study shows higher long-term cure with continuous Lamisil(R)tablets
compared with intermittent itraconazole in treatment of fungal toenail
infection (March 14, 2002)
9. Novartis awarded Prix Galien in France for innovative cancer therapy,
Glivec(R)(March 12, 2002)
10. Plaintiffs Withdrawal in New Jersey Marks Fifth and Final Dismissal of
all Class Actions Filed Against Maker of Ritalin in 2000 (March 7, 2002)
11. New survey results reinforce underdiagnosis and socioeconomic impact
of Irritable Bowel Syndrome (IBS) worldwide (March 4, 2002)
Page 2 of 30
Investor Relations Novartis International AG
NOVARTIS [LOGO] CH-4002 Basel
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 licenses Everolimus, the active ingredient in Certican TM, to Guidant
for use in drug eluting stents
Basel, Switzerland--28 March 2002 - Novartis Pharma AG announced today that
it had entered into a worldwide co-exclusive license agreement with Guidant
Corporation, granting Guidant rights to utilize the drug everolimus in drug
eluting stents for the treatment of coronary and peripheral vascular diseases.
Novartis will provide everolimus to Guidant, supply data to support Guidant
filings with regulatory agencies, and receive milestone payments and a royalty
on sales of Guidant products utilizing the drug. Pending regulatory approvals,
Guidant expects to initiate clinical trials of everolimus-eluting coronary
stents later this year.
Everolimus, a new investigational drug, is a potent proliferation inhibitor that
targets primary causes of chronic rejection in organ transplantation patients.
Guidant and Novartis have independently observed positive results in animal
studies evaluating the drug's effectiveness for the prevention of restenosis.
"We welcome this opportunity to collaborate with Guidant on medical innovations
that may offer new hope to patients with heart disease," said Thomas Ebeling,
CEO, Novartis Pharma AG.
Novartis has completed Phase III human clinical trials evaluating the safety and
efficacy of CerticanTM (an orally administered drug containing everolimus), for
the prevention of organ rejection in renal and heart transplant recipients.
The foregoing press release contains forward-looking statements that can be
identified by terminology such as "will provide," "expects", "offer new hope to
patients" 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
commercialization of any product in any market. Any such commercialization can
be affected by, among other things, uncertainties associated with the
development and
Page 3 of 30
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 materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those described herein as anticipated, believed, estimated or
expected.
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 30
Novartis International AG
NOVARTIS [LOGO] Novartis Communications
CH-4002 Basel
Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
--------------------------------------------------------------------------------
Novartis Consumer Health and Kao have agreed to end joint venture in Japan
Basel, 26 March 2002 - Novartis Consumer Health and Kao Corporation have agreed
to dissolve their consumer health joint venture, Novartis KAO Co., Ltd., in
Japan after one year of commercial presence in the Japanese market. Both parent
companies realized that it was in their best interests to dissolve the joint
venture as their initial expectations were not likely to be met within the
timeframe they had originally agreed upon.
Established in July 2000, the 50/50 joint venture was set up to market consumer
health care products, with a main focus on the marketing of over-the-counter
(OTC) products in Japan.
Novartis Consumer Health (NCH) remains committed to expanding its presence in
Japan and to bringing leading OTC healthcare products to Japanese consumers. In
particular, NCH will explore the many opportunities for potential switches of
successful prescription pharmaceuticals to OTC. Also the new OTC business unit
structure and strategic focus will help creating new entrepreneurial
opportunities and stimulating further growth in key markets.
Novartis Consumer Health (NCH) manufactures, develops and markets a wide range
of branded products, designed to restore, maintain or improve consumer and
animal health. The NCH business includes OTC (over-the-counter medicines),
Infant and Baby (including Gerber), CIBA Vision, Animal Health, and Medical
Nutrition, and - until divestment - Health and Functional Food.
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 5 of 30
Novartis International AG
NOVARTIS [LOGO] Novartis Communications
CH-4002 Basel
Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
--------------------------------------------------------------------------------
British study highlights women prefer Femara(R)in advanced breast cancer trial
Trial designed by independent panel of patients and physicians compares Femara
to Arimidex; study presented at major European breast cancer meeting suggests
patients' preferences should play greater role in treatment decisions
Barcelona, Spain, 20 March 2002 -- A study designed by an independent patient
advocacy group in the United Kingdom - the Information for Patients Research
Group (IPRG) comprised of clinicians, patients, nurses and other healthcare
professionals - suggests that patient preferences should be considered when
determining advanced breast cancer treatment. Presented at the third European
Breast Cancer Conference in Barcelona, Spain, the study compared Femara(R)
(letrozole) to Arimidex(R) (anastrozole) in postmenopausal women with advanced
breast cancer and found that more than twice as many women preferred Femara. The
focus of the IPRG is to improve quality of life for patients, and to design
clinical trials to ultimately empower patients and increase patient compliance.
"These are exciting results because this is the first trial to prove the
credibility of patient preference; the choice of women to continue taking Femara
at the end of the trial strongly correlated with a better quality of life and
less side effects on this treatment," said Dr. Robert Thomas, consultant
oncologist, Addenbrooke's Hospital (Cambridge) and Bedford Hospital NHS Trusts,
UK and lead investigator of this study. "The results of this study clearly show
the majority of women preferred Femara as it gave them a better quality of life
due to fewer side effects."
Study Results
The study analyzed quality of life through measurement of side effects. These
side effects included lethargy, hot flushes, headache, joint pains, abdominal
discomfort, nausea, appetite, fluid retention, wakefulness and thrombophlebitis.
Overall, at the end of the trial, more than twice as many women (Femara 68% vs.
Arimidex 32%) preferred to take Femara rather than Arimidex because they felt
better overall and experienced fewer hot flushes and less stomach upset. Women
generally experienced fewer side effects on Femara, but statistically
significant differences were found for lethargy (Femara 8% vs. Arimidex 19%),
headache (5% vs. 14%), joint pains (3% vs. 11%), abdominal discomfort (3% vs.
11%), nausea (10% vs. 22%) and poor
Page 6 of 30
appetite (2% vs. 8%). The results were reviewed by statisticians at Cambridge
University and were considered to be statistically significant.
Study Design
The primary objective of the IPRG study was to compare quality of life
associated with the use of Femara and Arimidex - aromatase inhibitors used to
treat postmenopausal women with advanced breast cancer. The 72 patients who
participated in the trial were divided into two groups. For the first four
weeks, one group took Femara while the other group took Arimidex. After a
six-day wash out period, the groups took the other therapy for four more weeks.
Patient preference was evaluated based on WHO toxicity questionnaires completed
by the women at days one, eight and 28 of each treatment. On the last day of
each therapy, the women also completed quality of life questionnaires
specifically designed and validated for women with breast cancer on hormone
therapies. At the end of the study, women completed a patient preference
questionnaire, and they were given the opportunity to evaluate the different
treatments and decide which treatment they preferred.
This study was designed by the IPRG to evaluate patients' preferences for a
particular treatment during approximately nine weeks of therapy; it was not
designed to monitor the clinical side effects as would be measured during a
trial evaluating a drugs' safety and efficacy. Therefore, the results of this
trial should be considered in conjunction with the scientific and medical data
of a given therapy.
About Femara
Clinical Data Demonstrate Survival Advantage Compared to Tamoxifen;
Data presented at 2001 San Antonio Breast Cancer Symposium
In a randomised, double-blind study of 907 postmenopausal women designed to
compare Femara vs. tamoxifen as first-line therapy in women with locally
advanced or metastatic breast cancer, survival rates at one and two years show
Femara to have a statistically significant survival advantage compared to
tamoxifen. The data also demonstrated that, approximately 5 years after
initiation of the study (November, 1996), more women who had begun their therapy
on Femara were still alive and free of tumour progression compared to those who
started on tamoxifen. In addition, patients taking Femara had a 78% greater
chance of responding to treatment than patients treated with tamoxifen, and the
chance that their tumours would progress was 30% less with Femara than with
tamoxifen.
Pharmacokinetic Data Demonstrates Femara Suppresses Oestrogens Better than
Anastrozole;
Data published in February 2002 issue of the Journal of Clinical Oncology
Data from a randomised study comparing the ability of Femara and anastrozole to
inhibit total body aromatisation and suppress plasma oestrogen levels in 12
postmenopausal women with metastatic breast cancer showed that Femara more
effectively inhibits total body aromatisation and suppresses plasma oestrogen
levels compared to anastrozole.
The differences between the two drugs in inhibiting total body aromatisation
were statistically significant. Although the clinical relevance of this finding
in terms of anti-tumour efficacy is yet to be determined, it must be emphasized
that the anti-tumour efficacy of all aromatase inhibitors relies on the
suppression of oestrogen production. The results of this study document that in
terms of oestrogen suppression, Femara reduces oestrogen production
significantly better than anastrozole.
Page 7 of 30
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for
postmenopausal women with hormone receptor positive or hormone receptor unknown
locally advanced or metastatic breast cancer. Femara is currently available in
more than 75 countries world-wide. Femara also is approved as neo-adjuvant
(pre-operative) therapy in more than 25 countries around the world.
Impact of Breast Cancer
More than 200,000 women in Europe are diagnosed with breast cancer each year,
accounting for more than 28% of all cancers among European women. The overall
lifetime risk of developing breast cancer for women is one in nine, representing
20-25% of all malignancies in European women.
Femara is contraindicated for patients with known hypersensitivity to letrozole
or any Femara excipients. Adverse reactions with Femara in the first-line study
were generally mild to moderate and were consistent with those seen in the
second-line studies. The most commonly reported adverse events for Femara vs.
tamoxifen were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain
(18% vs. 19%), nausea (17% vs. 17 %), dyspnoea or laboured breathing (18% vs.
17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%)
and constipation (10% vs. 11%). Femara may cause foetal harm when administered
to pregnant women. The incidence of peripheral thromboembolic events,
cardiovascular events and cerebrovascular events was <=2%. There is no clinical
experience to date on the use of Femara in combination with other anticancer
agents.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "the first trial to prove", "exciting result", "should
be", "may", "potential" or similar expressions. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause
actual results with Femara to be materially different from any future results,
performance or achievements expressed or implied by such statements. In
particular, management's expectations regarding further commercialisation of
Femara could be affected by, among other things, additional analysis of data;
new data; 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.
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 8 of 30
Investor Relations Novartis International AG
NOVARTIS [LOGO] CH-4002 Basel
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 -
--------------------------------------------------------------------------------
Diovan(R)reduced mortality by 33 per cent in heart failure patients who did not
take ACE inhibitors
New findings from Val-HeFT presented at American College of Cardiology meeting
Basel, Switzerland, 19 March 2002 - Findings released today by Valsartan Heart
Failure Trial (Val-HeFT) investigators demonstrate valsartan, an angiotensin II
receptor blocker (ARB), significantly reduced mortality by 33.1 per cent1 and
morbidity by 44 per cent (risk ratios 0.67 and 0.56, respectively) compared with
placebo in a cohort of heart failure patients who also took standard heart
failure therapies, but not ACE inhibitors.2 Findings were presented today at the
American College of Cardiology (ACC) Scientific Sessions by Professor Aldo
Maggioni, Val-HeFT investigator, from the GISSI Group, coordinated by the
Italian Association of Hospital Cardiologists (ANMCO) and the Istituto di
Ricerche Farmacologie, Mario Negri, Italy.
"Val-HeFT is a landmark trial that showed valsartan led to unprecedented
improvements in heart failure patients who were already taking standard
treatments with proven benefits as prescribed by their individual physicians,"
said Professor Maggioni. "Subsequent analysis showed valsartan not only reduced
morbidity but dramatically improved survival in patients whose physicians chose
not to prescribe ACE inhibitors. These data are critical because it provides
insight into the independent effects of valsartan in the absence of the most
commonly prescribed available heart failure treatment."
In Val-HeFT, 366 study patients were not prescribed ACE inhibitors by their
physicians. Analysis of these patients showed a significant reduction in
mortality (p=0.02) and morbidity (p=0.0002) in patients who took Diovan (n=185)
compared with those who took placebo (n=181) along with their other types of
prescribed heart failure therapy.1
Findings on secondary endpoints in the subgroup of patients not taking ACE
inhibitors were also consistently positive, indicating favourable effects on
disease progression.2 These secondary findings included significant reductions
in hospitalisations for heart failure (p=0.01),
Page 9 of 30
significant improvements in ejection fraction (p=0.0004), and significant
reductions in brain natriuretic peptide (BNP) (p=0.0004), a neurohormonal marker
for heart failure.2
"The new Val-HeFT analysis underscores the cardioprotective benefits of Diovan
in the management of heart failure" said Joerg Reinhardt, Global Head Pharma
Development, Novartis Pharma AG. "Novartis is committed to developing Diovan
across the full spectrum of cardiovascular disease."
A landmark study of 5,010 patients in 302 centres in 16 countries, Val-HeFT
studied the effects of valsartan in heart failure patients also taking
established therapies, which included beta blockers, diuretics, digoxin and ACE
inhibitors.2
Val-HeFT was the largest study ever conducted in heart failure. Overall findings
of Val-HeFT, published in the New England Journal of Medicine1 demonstrated
valsartan significantly reduced morbidity by 13.2 per cent (p=0.009) and
hospitalisation for heart failure by 27.5 per cent (p<0.001) in patients already
receiving prescribed therapy. Previously released findings also showed valsartan
significantly improved ejection fraction (p=0.001), NYHA functional class
(p<0.001) and clinical signs and symptoms of heart failure. Patients taking
valsartan also experienced a significantly better quality of life (p=0.005).*
The rate of all-cause mortality was similarly low in the two groups.1 The
benefits demonstrated in Val-HeFT did not appear to extend to the subgroup of
patients taking Diovan in combination with both an ACE inhibitor and a beta
blocker.2
Heart failure is currently the fastest growing cardiovascular disease in the
world and the most common reason why the elderly are hospitalised. An estimated
20 million people worldwide suffer from this devastating condition.
Diovan is already approved for first-line treatment of high blood pressure in
more than 80 countries, including the US, and is one of the fastest growing
agents among the top 10 branded prescription medications for this condition. An
estimated three million patients worldwide take Diovan for high blood pressure.
Diovan is supported by the world's largest clinical trial programme with an ARB.
Besides Val-HeFT, other trials examining the effect of Diovan beyond its
existing indication for hypertension include VALUE (high-risk patients with
hypertension), VALIANT (post-myocardial infarction patients), and NAVIGATOR
(patients with impaired glucose tolerance at high risk for cardiovascular
events).
This release contains certain "forward-looking statements", relating to the
business of Novartis, which can be identified by the use of forward-looking
terminology such as "reduced mortality", "unprecedented improvements",
"dramatically improved survival", "consistently positive", "favourable effects",
"significant improvements", "cardioprotective", "full spectrum", "fastest
growing", "estimated or similar expressions. Such forward looking statements
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 are no guarantees
that the aforementioned data will result additional regulatory approvals for
Diovan or in increased sales of Diovan. Any such commercialization
Page 10 of 30
can be affected by, amongst other things, uncertainties relating to product
development, regulatory actions or delays or government regulation generally,
the ability to obtain or maintain patent or other proprietary intellectual
property protection and 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.
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.
###
*compared with patients taking placebo and prescribed therapy as evaluated by
the Minnesota Living with Heart Failure Questionnaire, a standard assessment
1 Cohn, Jay, "A Randomized Trial of the Angiotensin-Receptor Blocker Valsartan
in Chronic Heart Failure," N Engl J Med, Vol. 345, No. 23, December 6,
2001.
2 Maggioni, Aldo et. al, "Effects of Valsartan on Morbidity and Mortality in HF
Patients not
Page 11 of 30
Investor Relations Novartis International AG
NOVARTIS [LOGO] CH-4002 Basel
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 -
--------------------------------------------------------------------------------
Landmark clinical trial demonstrates Lescol(R) protects against future fatal and
non-fatal cardiac events
First statin to show protective effects in revascularized patients in a
prospective study
Basel, 19 March, 2002 - A landmark clinical trial presented at the American
College of Cardiology (ACC) has demonstrated that treatment with Lescol(R)
(fluvastatin sodium) 80 mg/day (administered as 40 mg twice daily) in patients
who have undergone their first coronary surgical procedures for heart disease,
known as percutaneous coronary interventions (PCI), significantly protects
against future fatal or non fatal cardiac events. The Lescol Intervention
Prevention Study (LIPS) results demonstrate that treatment with Lescol 80 mg
significantly reduced the risk of major adverse cardiac events by 22% as
compared with placebo (P=0.013). Major adverse cardiac events were defined as
cardiac death, nonfatal myocardial infarction, coronary artery bypass grafting
or repeat percutaneous coronary intervention.
LIPS is the first prospectively designed, placebo controlled trial in this
target population to demonstrate that cholesterol-lowering treatment with a drug
of the statin class prevents future fatal or non-fatal cardiac events. It is an
international study, supported by Novartis, that followed 1677 patients
recruited from 57 centers in 10 countries (Europe, Canada, and Brazil) for 3 to
4 years. Patients were randomized to receive either Lescol 80 mg/day or placebo
before hospital discharge after their first PCI coronary surgical procedure.
"The LIPS data show for the first time in a prospective trial in patients with
heart disease who undergo their first coronary PCI surgical procedure that we
can prevent fatal or non fatal cardiac events in this target population with
statin treatment. While these procedures are very effective in patients with
heart disease, there has been a tremendous need to improve long-term success
rates. Moreover, the LIPS results support the recommendation to initiate
lipid-lowering treatment with statins in patients undergoing their first
coronary PCI surgical procedure as early as before hospital discharge" said
Principal Investigator, Patrick WJC
Page 12 of 30
Serruys, MD, PhD, Professor of Interventional Cardiology at Erasmus University
Hospital, Rotterdam, The Netherlands.
Worldwide percutaneous coronary interventions were 1.8 million in 2001 growing
at +8.8% per year1. The procedures include balloon angioplasty, stent placement,
rotational or directional atherectomy, and laser ablation, and are performed to
open clogged arteries. While 90% of patients who undergo the procedures have
immediate improvement in the chest pain known as angina, 66% of patients die or
have a cardiac event within 10 years of surgery 2.
In certain groups of high-risk patients in LIPS, the benefits of Lescol were
even more pronounced. Patients with diabetes (12% of the total study
population), experienced a 47% risk reduction compared with placebo (P=0.041),
while those with multivessel disease (37% of the total study population),
experienced a 34% risk reduction compared with placebo (P=0.011).
Levels of harmful LDL cholesterol were significantly reduced with Lescol
treatment to mean levels below 100 mg/dL (2.6 mmol/L) throughout the course of
the study. LIPS data thus support the NCEP ATP III guidelines to lower LDL
cholesterol to below the target level of 100 mg/dL (2.6 mmol/L) in all patients
after a percutaneous coronary intervention.
Data from LIPS also underscore the excellent safety profile of Lescol. In LIPS,
there were no significant elevations of creatine phosphokinase (CPK) over the
3-4 years of follow up above 10x ULN (elevated CPK is an indication of muscle
breakdown which is a potential side effect of the statin class of drug). These
safety data match those from a recent analysis involving 9,000 patients of all
randomised, controlled clinical trials with Lescol/Lescol XL(R) administered as
monotherapy, in which the rate of clinically relevant CPK elevations was not
significantly different at any Lescol dose than in patients receiving placebo3.
Novartis introduced Lescol extended-release, once-daily 80 mg formulation in
2000 (Lescol XL), which has been shown in trials to provide effective lipid
management, with reductions of 38% in harmful LDL-cholesterol, up to 31% in
triglycerides and increases of up to 21% in favorable HDL-cholesterol4.
This release contains certain "forward-looking statements", relating to the
business of Novartis, which can be identified by the use of forward-looking
terminology such as " class prevents future fatal or non-fatal cardiac events",
" effective lipid management", or similar expressions. Such forward looking
statements 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 are
no guarantees that the aforementioned clinical trials will result in the
commercialisation of any product in any market. Any such commercialisation can
be affected by, amongst other things, uncertainties relating to product
development, regulatory actions or delays or government regulation generally,
the ability to obtain or maintain patent or other proprietary intellectual
property protection and 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 materialise, or should underlying
assumptions prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or expected.
Page 13 of 30
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.
# # #
References:
1 [J.P.Morgan Securities Inc. ]
2 Ruygrok PN, de Jaegere PT, van Domburg RT, et al. Clinical outcome 10
years after attempted percutaneous transluminal coronary angioplasty in 856
patients. Am Coll Cardiol. 1996;27:1669-1677.
3 Benghozi et al. Frequency of creatinine kinase elevation during treatment with
fluvastatin. Am J Card 2002, Jan 15.
4 Ballantyne et al: Efficacy and Tolerability of Fluvastatin Extended-Rleases
Delivery System: A Pooled Analysis. Clinical Therapeutics 2001, No 2, Vol 23,
p177-192
Page 14 of 30
Investor Relations Novartis International AG
NOVARTIS [LOGO] CH-4002 Basel
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 -
--------------------------------------------------------------------------------
Two further marketing approvals for Zelnorm(TM)/Zelmac(R)
Green lights for Novartis' new IBS therapy in Canada and Brazil
Basel, 19 March 2002 - Novartis announced today that Health Canada's Therapeutic
Products Directorate has granted marketing authorization for Zelnorm(TM)
(tegaserod)*, for the symptomatic treatment of irritable bowel syndrome (IBS) in
women whose main symptoms are abdominal pain/discomfort and constipation. The
company also announced that the Brazilian Regulatory Authority, ANVISA, has
granted marketing authorisation for Zelmac(R) (tegaserod) for the treatment of
abdominal pain/discomfort, bloating and constipation.
"Zelnorm/Zelmac is the first medication clinically proven to offer relief from
the multiple symptoms of IBS," said Thomas Ebeling, CEO, Novartis Pharma AG.
"These positive decisions further support the promise of Zelnorm/Zelmac as a
future treatment of choice for both physicians and patients."
Canadian approval The prevalence of IBS in Canada ranges from 6-13.5%(1,2), with
two-thirds of sufferers being female.(1) Zelnorm is the first single effective
therapy available in Canada to treat the multiple symptoms of IBS, which include
abdominal pain/discomfort, bloating and altered bowel function.
"There are very few treatment options for patients suffering from Irritable
Bowel Syndrome," said Gervais Tougas, MD, Head of GI Services, St Joseph's
Healthcare and Associate Professor of Medicine, McMaster University, Hamilton,
Canada. "Tegaserod targets many of the symptoms that so far we have had
difficulty treating, in particular pain, bloating and constipation. The approval
of tegaserod in Canada represents an important new alternative for physicians
treating this debilitating condition."
Page 15 of 30
Brazilian approval
The prevalence of IBS in Brazil ranges from 8.7% - 17.0% with 58.6% of sufferers
being female.(3) In Brazil, Zelmac will be available to treat the multiple
symptoms of IBS, which include abdominal pain/discomfort, bloating and altered
bowel function.
"The approval of Zelmac in Brazil brings hope to the many patients suffering
from the chronic, debilitating symptoms of IBS with predominance of
constipation," said Carlos Fernando Francisconi, MD, FACG, Associate Professor
in Internal Medicine, Department of Gastroenterology at Universidade Federal do
Rio Grande do Sul and PUC Rio Grande do Sul, Chief of Gastroenterology Divison
at Hospital das Clinicas de Porto Alegre. "I am optimistic that this product
will significantly improve the quality of life of thousands of Brazilian women."
About Zelnorm/Zelmac
Zelnorm/Zelmac is now approved in more than 20 countries to include Australia,
Switzerland and several other Latin American countries. Novartis continues to
work with the US Food and Drug Administration and the European Agency for the
Evaluation of Medicinal Products to help bring the benefits of this important
new therapy to patients in need.
Clinical Data The approvals of Zelnorm/Zelmac are based on clinical trials
involving more than 4500 patients. Throughout the trials two-thirds of patients
treated with Zelnorm experienced overall symptom relief, including improvements
in abdominal pain/discomfort, bloating and constipation.(4) The majority had
relief within one week.(5) The drug was well tolerated with an adverse event
profile similar to that of placebo, with the exception of headache and diarrhea,
which in most cases was mild and transient(6,7). Discontinuations based on
adverse events were 6.4% for the Zelnorm-treated group compared with 4.6% for
the placebo group in the final trial.(4)
The foregoing press release contains certain forward-looking statements related
to the business of Novartis, which can be identified by the use of
forward-looking terminology such as "will", "improve", "further supports the
promise", "future treatment of choice", "first single effective therapy", "an
important new alternative" "help bring the benefits", "an important new
therapy", or similar expressions. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause actual results
with tegaserod to be materially different from any future results, performance
or achievements expressed or implied by such statements. Management's
expectation regarding the commercial potential of tegaserod in any market could
be affected by, amongst other things, uncertainties relating to product
development, regulatory actions or delays or government regulation generally,
the ability to obtain or maintain patent or other proprietary intellectual
property protection and 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 16 of 30
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.
----------------------------------
References:
1. Thompson WG, et al. Functional GI disorders in Canada: first population-based
survey using Rome II criteria with suggestions for improving the
questionnaire. Dig Dis Sci 2002;47:225-235.
2. Bentkover JD, et al. The economic burden of irritable bowel syndrome in
Canada. Can J Gastroenterol 1999;13(Suppl A):89A-96A.
3. Quilici F.A., Andre S.B. Sindrome do Intestino Irritavel - Um consenso
nacional. Lemos Editorial, Sao Paulo , Brazil, 2000.
4. Mueller-Lissner S, et al. Tegaserod, a 5-HT4 partial agonist, relieves
symptoms in irritable bowel syndrome patients with abdominal pain, bloating
and constipation. Aliment Pharmacol Ther 2001;16:1655-66.
5. Integrated summary of efficacy. January 2000. Novartis, data on file.
6. Lefkowitz M, et al. Tegaserod provides relief of symptoms in female patients
with irritable bowel syndrome (IBS) suffering from abdominal pain and
discomfort, bloating and constipation. (Abstr).
Gastroenterology 2001;120:A104.
7. Integrated summary of safety. December 2000. Novartis data on file.
# # #
Page 17 of 30
Investor Relations Novartis International AG
NOVARTIS [LOGO] CH-4002 Basel
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' new non-steroid eczema treatment, Elidel(R)cream, approved for use in
babies to adults in Denmark
Denmark becomes the first country in Europe to approve Elidel cream Novartis to
apply to other EU countries in 2002 for marketing authorization
Basel, 18 March 2002 - Novartis announced today that its new atopic eczema
treatment, Elidel(R) (pimecrolimus), has become the first non-steroid
prescription cream approved for patients from as young as 3 months of age
through to adulthood. The Danish Medicines Agency is the first health authority
in Europe to approve Elidel cream for the itching skin condition which is also
known as atopic dermatitis. Novartis will seek approvals in other European
countries during 2002 under the Mutual Recognition Procedure, and elsewhere
around the globe.
"We are delighted with this decision. Elidel is the first non-steroid
prescription cream to be approved for treating eczema in babies, children and
older patients, and does not carry the risk of steroid-associated side effects
such as thinning of the skin. We believe Elidel represents the most significant
advance in treating eczema since topical corticosteroids were introduced more
than 50 years ago." said Thomas Ebeling, Chief Executive Officer of Novartis
Pharma AG. "Eczema is an increasingly prevalent condition, with the number of
reported cases having risen by 30% over the last 30 years."
About 23% of people in Denmark, and one in five in the Western world, suffer at
some time in their life from eczema, an incurable disease characterized by red,
itching skin that can ooze and crust in its most severe form. While most
patients, about 60%, grow out of the condition by their late teens, others
suffer throughout their lives.
Elidel cream is expected to be available in Denmark around mid-year. It is
indicated for the short-term treatment of the signs and symptoms of atopic
eczema and intermittent long-term treatment to prevent progression to flares in
patients aged 3 months and above. It is approved for use in patients in whom
conventional topical corticosteroid therapy is not advisable
Page 18 of 30
because of potential risks, or in patients who are not adequately responsive to,
or are intolerant of, conventional topical corticosteroid therapy.
"The approval of Elidel for use in babies is particularly welcome because eczema
is a condition that typically begins in infancy, with half of all eczema
patients being diagnosed before their first birthday. Elidel will give us the
option to control atopic eczema in the long term without running the risk of the
side effects associated with steroids. This is a remedy that doctors will
welcome and I am sure patients will too," said Professor Kristian
Thestrup-Pedersen, a world expert on atopic eczema and Professor of Dermatology
at the Marselisborg Hospital in Aarhus, Denmark.
The Danish approval is based on clinical trials involving more than 2000
patients which showed that Elidel cream can reduce itching within the first 3
days of treatment. When applied at the first signs or symptoms of eczema, Elidel
cream has also been shown to reduce the incidence of flares (severe redness and
swelling, which may be accompanied by oozing and crusting of the skin) in 70% of
infants (aged 3-23 months) and in 61% of children aged 2-17 years over 6 months.
In adults, 49% of those treated with Elidel cream were able to control their
eczema over six months without any steroids.
Elidel cream may be used on all skin surfaces, including delicate areas such as
the face, neck and skin folds. The most common side effect reported on the skin
was a mild to moderate, transient feeling of warmth or burning (occurring in 7%
of pediatric patients aged 3 months to 17 years and in 15% of adults). Other
common side effects included headache and cold-like symptoms. These effects were
temporary and their occurrences were comparable to those experienced by patients
on vehicle (placebo) cream.
Elidel cream has already been approved in the USA for patients over 2 years of
age, and is due to be launched there this month. Novartis is in discussion with
the US Food and Drug Administration to submit long-term data to support a
licence for use in patients under 2 years.
Elidel cream was discovered by Novartis scientists in Vienna, Austria. Its
active ingredient is pimecrolimus, which is derived from ascomycin, a natural
substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus.
A skin-selective inflammatory cytokine inhibitor, Elidel cream works by
selectively blocking the synthesis and release of inflammatory cytokines from T
cells in the skin. It is these cytokines that trigger processes leading to the
inflammation, redness and itching associated with eczema.
This press release contains forward looking statements which can be identified
by the use of forward-looking terminology such as "new treatment," "first... to
approve," "will seek approval," "is expected," "will welcome," "can reduce," or
similar expressions. Such forward looking statements 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 are no guarantees that the
aforementioned clinical trials will result in the commercialization of Elidel
cream in any market. Any such commercialization can be affected by, amongst
other things, uncertainties relating to product development, regulatory actions
or delays or government regulation generally, the ability to obtain or maintain
patent or other proprietary intellectual property
Page 19 of 30
protection and competition in general, as well as factors discussed in Novartis
AG's Form 20F filed with the Securities and Exchange Commission. Any of these
and other factors can cause the actual results to differ materially from the
expected or predicted results.
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 30
Novartis International AG
NOVARTIS [LOGO] Novartis Communications
CH-4002 Basel
Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
--------------------------------------------------------------------------------
New study shows higher long-term cure with continuous Lamisil(R) tablets
compared with intermittent itraconazole in treatment of fungal toenail infection
Novartis' Lamisil confirms its superior clinical efficacy in longest follow-up
study in toenail onychomycosis
Basel, 14 March 2002 - Novartis announced today the results of a long-term
head-to-head study of Lamisil(R) (terbinafine hydrochloride) and itraconazole,
evaluating cure and relapse rates in toenail onychomycosis (fungal nail
infection). The study, reported in the Archives of Dermatology, confirms that
continuous therapy with Lamisil tablets is significantly more effective and
offers lower rates of relapse in the long term than treatment with intermittent
itraconazole.
"The findings from this study demonstrate that patients with toenail
onychomycosis taking Lamisil, are more likely to remain fungus-free with a
decreased likelihood of relapse over the long term, compared with patients
treated with itraconazole," said Bardur Sigurgeirsson, Lead Author of the study
and Assistant Professor of Dermatology at the University of Iceland and National
University Hospital in Reykjavik, Iceland. "This is welcome news for the
millions of patients world-wide who suffer from this infection."
The Lamisil versus Itraconazole in Onychomycosis Icelandic Extension Study
(L.I.ON. I.E.S.) showed that significantly more patients treated with Lamisil
(46%, p<0.001) remained mycologically cured at the end of the 54-month follow-up
without a second intervention(1) treatment compared with itraconazole (13%).
Mycological and clinical relapse rates were also significantly lower with
Lamisil (23% and 21% respectively) compared with itraconazole-treated patients
(53% and 48% respectively). Of the 72 patients who received Lamisil treatment as
second intervention, 88% achieved mycological cure(2) and 76% clinical cure(3).
The L.I.ON. I.E.S. study represents the longest prospective blinded follow-up
study of patients treated for toenail onychomycosis. Its primary efficacy
endpoint was the proportion of patients who remained mycologically cured at the
end of the L.I.ON. I.E.S. follow-up, without requiring second intervention
treatment with Lamisil. The L.I.ON. I.E.S. study is an extension of the L.I.ON.
study, originally published in April 1999 in the British Medical Journal (BMJ)
which followed 496 patients over 18 months. During the L.I.ON. study, patients
received
Page 21 of 30
either Lamisil (250 mg/day) or itraconazole (400 mg/day for one week in
every four) over a total period of 12 or 16 weeks. The L.I.ON. study showed that
mycological cure rates in the 12-week treatment groups were 76% with Lamisil,
compared with 38% among itraconazole-treated patients (p<0.0001), at the end of
the 18-month follow-up.
The L.I.ON. I.E.S. study followed 151 patients from the original L.I.ON. study
for a median duration of 54 months. Patients who entered this extension study
who were not cured at month 18 of the L.I.ON. study or experienced
relapse/reinfection, were offered an additional course of Lamisil treatment (250
mg/day for 12 weeks), defined as second intervention.
"More than 19 million patients world-wide have benefited from the use of Lamisil
to treat onychomycosis. These results confirm that Lamisil is the most effective
cure for this infection," said Thomas Ebeling, CEO of Novartis Pharma. "We
believe this long-term follow-up data is of clinical significance to the
physicians making treatment decisions."
The forgoing press release contains forward-looking statements, which can be
identified by terminology such as "long-term cure," "shows that," "significantly
more effective," "more likely," "welcome news," "study showed," "we believe," or
similar expressions. Such forward looking statements 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 are no guarantees that the
aforementioned clinical trial will result in the commercialisation or the
continuing commercialisation of any product in any market. Any such
commercialisation can be affected by, amongst other things, uncertainties
relating to product development, regulatory actions or delays or government
regulation generally, the ability to obtain or maintain patent or other
proprietary intellectual property protection and competition in general, as well
as factors discussed in Novartis AG's Form 20F filed with the 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.
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.
# # #
1 Second intervention (an additional course of Lamisil treatment) was
offered to patients from either of the treatment groups who did not achieve
clinical cure at the end of the 18 month follow-up of the L.I.ON. study
2 Mycological cure is defined as negative results on both microscopy and
culture of samples taken from the target toenail
3 Clinical cure is defined as 100% normal appearing nail
Page 22 of 30
Novartis International AG
Novartis Communications
CH-4002 Basel
Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
--------------------------------------------------------------------------------
Novartis awarded Prix Galien in France for innovative cancer therapy, Glivec(R)
First time award given two years in a row to same pharmaceutical company in one
country; 12th Prix Galien overall for Novartis
Basel, 12 March 2002 - Novartis has been awarded the prestigious Prix Galien in
France for the second year in a row, marking the first time that the same
pharmaceutical company has won this distinction for two years in succession.
This is the 12th time Novartis has been awarded the Prix Galien award for
innovative therapies. The winning compound this year is Glivec(R) (imatinib)(1),
a treatment for patients with chronic myeloid leukemia (CML). 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.
"Winning twelve Prix Galien awards, and winning twice in a row in France, is a
major accomplishment for Novartis," said Thomas Ebeling, CEO of Novartis Pharma.
"It is especially rewarding to win the award for Glivec. This is a drug that the
entire company worked very hard to bring to market and it offers CML patients
real hope against their cancer."
About Glivec
Glivec targets the activity of a type of enzyme, called tyrosine kinases, which
play an important role within certain cancer cells. It works by inhibiting the
the abnormality that characterizes CML in most patients. Additionally, the
activity of one of the tyrosine kinases that Glivec has been shown to inhibit,
known as c-kit, is thought to drive the growth and division of most GISTs.
Glivec was approved in the EU on 7 November 2001 for its initial treatment of
chronic myeloid leukemia (CML) in chronic phase after failure of
interferon-alpha therapy, or in accelerated phase or blast crisis. To date,
Novartis has received marketing clearance for Glivec for the CML indication in
the European Union and more than 60 countries. The effectiveness of Glivec is
based on overall hematologic and cytogenetic response rates. There are no
controlled trials demonstrating a clinical benefit, such as improvement in
disease-related
(1) Outside the US: Glivec (imatinib); in the US: Gleevec(TM)(imatinib mesylate)
Page 23 of 30
symptoms or increased survival. In the treatment of CML, it is designated as an
Orphan Drug in the United States, European Union and Japan. Novartis received a
positive opinion for Glivec for the treatment of adult patients with Kit (CD
117) positive unresectable and/or metastatic malignant gastrointestinal stromal
tumors (GIST) from the Committee for Proprietary Medicinal Products (CPMP) in
the EU on 22 February 2002. Glivec was also granted Orphan Drug designation by
the European Union (EU) and the US for GIST.
About the Prix Galien
The Prix Galien recognizes innovative therapeutic drugs that have made a
substantial improvement in therapy. The prize is sponsored by medical media from
different countries including Germany, France, Canada, and, since 2001, the
United States. An independent jury consisting of top researchers and opinion
leaders decides the winner. Since 1970, Novartis has received 12 Prix Galien in
six countries for the innovative therapies Rimactan(R), Parlodel(R),
Sandimmune(R), Sandostatin(R), Simulect(R), Visudyne(R) (for which France won
the award last year) and now Glivec(R).
The foregoing release contains forward-looking statements that can be identified
by terminology such as "offers CML patients real hope," 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; 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.
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 24 of 30
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
Tel 973 781 8300
Internet Address:
http://www.pharma.us.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o MEDIA RELEASE o MEDIA RELEASE
--------------------------------------------------------------------------------
Plaintiffs Withdrawal in New Jersey Marks Fifth and Final Dismissal of all Class
Actions Filed Against Maker of Ritalin in 2000
BERGEN COUNTY, NJ, MARCH 7, 2002 - Novartis Pharmaceuticals Corporation,
manufacturers of Ritalin(R) (methylphenidate) announced today plaintiffs
involved in New Jersey class action litigation have filed a voluntary notice of
dismissal. This action brings to a close the fifth and final of all similar
class action lawsuits filed against the company in 2000. On October 26, 2001,
Honorable Charles Walsh of the Superior Court of New Jersey in Bergen County
ruled from the bench that the plaintiffs' claim was insufficient and gave them
90 days to refile a more specific claim. Plaintiffs filed the notice of
dismissal after the deadline for the submitting their revised complaint had
passed. The lawsuit in New Jersey claimed Novartis conspired with the American
Psychiatric Association (APA) and Children and Adults with
Attention-Deficit/Hyperactivity Disorder (CHADD) to promote the diagnosis of
Attention-Deficit/Hyperactivity Disorder (ADHD).
"We are extremely pleased with the plaintiffs' decision," said Novartis General
Counsel, Dorothy Watson. "This action, and the fact that all five of the class
action lawsuits have been dismissed, sends a strong message that the decision of
how to treat ADHD is between the parent, patient and physician, and has no place
in the courts."
The first dismissal of a class action suit of this type occurred in California
on April 23, 2001. U.S. District Judge Rudi Brewster dismissed the suit under
California's anti-SLAPP statute -- a statute designed to weed out of the court
system at their inception, lawsuits which are in reality political actions
designed to intimidate defendants from exercising their First Amendment rights.
Judge Brewster dismissed the suit stating that the defendants' speech is
"protected under both the United States and California Constitutions" and that
plaintiffs "failed to state a cause of action." In addition to dismissing the
suit, the court also ordered that the plaintiffs pay the legal fees for
Novartis, APA and CHADD. Plaintiffs have appealed Judge Brewster's decision.
On May 18, a Texas judge also dismissed a similar class action suit filed in
that state. U.S. District Judge Hilda G. Tagle found that the plaintiffs in that
class action failed to state their claims of fraud and conspiracy with
sufficient particularity. Additionally, she found that the plaintiffs' vague
mentions of side effects in their complaint failed to state a legal claim. The
plaintiffs had until June 20 to appeal the ruling; however, they did not do so.
Page 25 of 30
On July 5, plaintiffs involved in class action litigation in Florida alerted the
court of their intent to dismiss the class action that had been filed in
Orlando. In a related action on August 16, plaintiffs involved in litigation in
Puerto Rico notified the court of their intent to dismiss the lawsuit in San
Juan. The dismissal in New Jersey represents the fifth and final class action
lawsuit to be dismissed.
Contrary to the position advanced in the lawsuits, ADHD is a real and serious
disorder. It is a well-established and valid diagnosis recognized by the leading
medical authorities in the U.S., including the American Medical Association,
American Psychiatric Association, American Academy of Pediatrics, the U.S. Food
and Drug Administration and the U.S. Surgeon General.
Ritalin has been shown to be an effective and safe medication for more than 45
years and has been scientifically evaluated in more than 200 studies involving
over 6,000 school-aged children.
"Ritalin and similar treatments are among the most widely studied therapies
available," said Watson. "We're heartened that an overwhelming body of
scientific evidence cannot just be litigated away by lawyers and anti-psychiatry
advocates."
Ritalin is a mild central nervous system stimulant that helps to address the
neurochemical problems underlying attention deficit hyperactivity disorder
(ADHD).
Novartis Pharmaceuticals Corporation researches, develops, manufacturers and
markets leading innovative prescription drugs used to treat a number of diseases
and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory
disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an
affiliate of Novartis AG (NYSE: NVS), 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.
# # #
Contact:
Gina Moran Denise Brashear
Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals Corporation
PH: 973-781-5567 PH: 973-781-7336
FX: 973-781-7828 FX: 973-781-7828
Email: regina.moran@pharma.novartis.com Email: denise.brashear@pharma.
novartis.com
Page 26 of 30
Novartis International AG
Novartis Communications
CH-4002 Basel
Switzerland
Tel +41 61 324 2200
Fax + 41 61 324 3300
Internet Address:
http://www.novartis.com
--------------------------------------------------------------------------------
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
--------------------------------------------------------------------------------
New survey results reinforce underdiagnosis and socioeconomic impact of
Irritable Bowel Syndrome (IBS) worldwide
Important data from "Truth in IBS" (T-IBS) survey presented at the 12th World
Congress of Gastroenterology meeting in Thailand
Basel, 4 March 2002 -- Novartis announced today new findings from the "Truth in
IBS" (T-IBS) survey. These results show a higher incidence of abdominal surgery
and highlight the substantial economic impact on health resources, number of
sick days taken off from work among IBS sufferers, and the significant loss to
patient quality of life due to this common condition. These results will be
presented at the 12th World Congress of Gastroenterology meeting in Bangkok,
Thailand.
Based on a questionnaire administered to current IBS sufferers (3,594
respondents) and a control group of non-sufferers (4,720), researchers found
that current IBS sufferers visited a nurse or doctor 63% more often than
non-sufferers and missed more days of work per year (5.5 vs. 3.1 days in the
last year). The survey also found that there was a 32% higher incidence of
abdominal surgery among IBS sufferers compared with non-sufferers.1
"The results of the T-IBS survey highlight the significant economic impact of
this condition due to the need for abdominal surgery in patients with IBS, which
poses an enormous burden on healthcare systems worldwide," said Pali Hungin,
Professor of Primary Care and General Practice at the University of Durham in
the United Kingdom. "IBS patients are forced to miss work and limit day-to-day
activities reinforcing the need for an effective treatment option for the
millions who suffer from the multiple symptoms of IBS."
Additional data from T-IBS highlight the personal impact this condition has on
an individual's quality of life. Interviews with respondents determined that a
majority of patients experienced symptoms daily, commonly more than once. Among
the primary abdominal symptoms reported during an attack, which had an average
duration of one hour twice per day, were pain (88%), bloating (80%) and
tiredness (60%), an associated symptom underestimated in the past. Women
reported higher rates of IBS symptoms overall, particularly constipation
(61%).(1)
Page 27 of 30
About T-IBS
The T-IBS study was conducted to assess the global prevalence and impact of IBS
in eight European countries: the UK, Germany, Belgium, the Netherlands,
Switzerland, Spain, Italy, France and the U.S. A telephone survey, utilising
random digital dialing technology, contacted 42,065 individuals and obtained
information on general health, including symptoms consistent with IBS. Overall
prevalence of IBS, including patients formally diagnosed and those not formally
diagnosed but with IBS symptoms, was determined to be 11.6%.(1)
About IBS
Irritable bowel syndrome (IBS) is a chronic disorder, which can be difficult to
diagnose. The multiple symptoms of IBS, including abdominal pain/discomfort,
bloating and constipation, easily go undetected and do not show up with common
tests such as blood tests or x-rays. The prevalence of IBS differs by country.
However, current findings/studies indicate that IBS affects approximately 10-20
percent of the western population(2).
It is recognized that in the West, women tend to present to doctors with
symptoms of IBS more frequently than men. A female to male ratio of up to 2.4 to
1 has been reported(3). The apparently higher presentation of IBS in women is
seen in all age groups and may be a reflection of the fact that women are likely
to seek medical advice more often than men.
About Zelmac
Zelmac is a 5-HT4 receptor selective partial agonist that provides rapid and
sustained relief for patients suffering from the multiple symptoms of abdominal
pain/discomfort, bloating and constipation associated with IBS. Zelmac is
approved in Australia, Switzerland and in several Latin American countries
including Mexico, Argentina, Venezuela and Columbia. Novartis continues to work
with the U.S. Food and Drug Administration (FDA) and the European Agency for the
Evaluation of Medicinal Products (EMEA) to help bring the benefits of this
important new therapy to patients in need.
The foregoing press release contains certain forward-looking statements related
to the business of Novartis, which can be identified by the use of
forward-looking terminology such as "will", "soon", or similar expressions. Such
forward-looking statements 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. Management's expectation regarding the commercial potential of
tegaserod in any market could be affected by, amongst other things,
uncertainties relating to product development, regulatory actions or delays or
government regulation generally, the ability to obtain or maintain patent or
other proprietary intellectual property protection and 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
materialise, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
Page 28 of 30
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.
# # #
References:
1. Hungin APS, et al. Symptoms and Patterns of Irritable Bowel Syndrome
in the General Population - the Truth in IBS (T-IBS) Survey, The Medical
and Societal Impact of Irritable Bowel Syndrome (IBS): the Truth in IBS
(T-IBS) Survey. Presented at the 12th World Congress of Gastroenterology
Meeting, Bangkok, Thailand.
2. Thompson, WG et al. Functional bowel disorders and functional abdominal
pain. Gut 1999;45 (Suppl II): II43-II47.
3. Everhart JE, Renault PF. Irritable bowel syndrome in an office-based
practice in the United States. Gastroenterology 1991;100:998-1005.
Page 29 of 30
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: April 3, 2002 By: /s/ RAYMUND BREU
-------------------------
Name: Raymund Breu
Title: Chief Financial Officer
-----------------------------