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 June 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. Stevo Julius Award for Education in Hypertension presented to two pioneers
in hypertension research
2. Federal District Court Rules in Favor of Wesley Jessen, Grants Injunction
in Patent Infringement Case Filed Against Bausch & Lomb
3. Lescol(R)shown to reduce risk of serious cardiac events following surgery
to open constricted coronary arteries
4. Novartis Ophthalmics teams with Carter Center to fight painful, blinding
diseases
5. Novartis secures first marketing approval for breakthrough asthma drug as
Australia approves Xolair(R)
6. Starlix(R)(nateglinide) significantly improves glycaemic control in
metformin patients with type 2 diabetes
Page 1 of 41 Total Pages
7. Data suggest that Prexige(TM)(lumiracoxib), a new COX-2 inhibitor, offers
strong efficacy
8. Novartis announces recipients of Diabetes Award
9. Estalis(R)HRT patch demonstrates positive effects on sexual functioning in
postmenopausal women in comparison with pills
10. New data show Glivec(R)as first-line treatment for chronic myeloid leukemia
maintains quality of life
11. FDA grants marketing clearance for Ritalin(R)LA, a once-daily formulation
of Ritalin(R)for ADHD that lasts through the entire school day
12. Novartis launches new educational ADHD web site
13. Novartis introduces S.T.A.R.T. (Straight Talk About Responsible Treatment)
Now program to educate about appropriate use of ADHD medications
14. Novartis awarded 2002 international Galien Prize for innovative cancer
therapy, Glivec(R)
Page 2 of 41 Total Pages
[NOVARTIS LOGO] 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
Stevo Julius Award for Education in Hypertension presented to two pioneers in
hypertension research
Prestigious Award presented by the International Society of Hypertension
Basel, 28 June 2002 - John Laragh, MD and Jeremiah Stamler, MD, both known
worldwide for their significant contributions to the research and understanding
of hypertension, and the leadership they have provided to many young scientists,
have received the Stevo Julius Award for Education in Hypertension. Dr Laragh's
role in understanding the renin-angiotensin-aldosterone system (RAAS) and its
subsequent inhibition was a critical breakthrough and led to significant
advances in the treatment of heart disease. Dr Stamler's landmark research into
risk factors for coronary heart disease greatly influenced practice in terms of
the prevention and control of cardiac disease. The award was supported by an
educational grant from Novartis Pharma AG and presented by the International
Society of Hypertension during the joint meeting of the International Society of
Hypertension and the European Society of Hypertension.
"As a world leader in cardiovascular research and therapies, Novartis is honored
to partner with the International Society of Hypertension in sponsoring the
prestigious Stevo Julius Award for Education in Hypertension," said Joerg
Reinhardt, Global Head of Development for Novartis Pharma AG. "We applaud Drs
Laragh and Stamler for their outstanding achievements and discoveries in
hypertension and other cardiovascular disease. Together, they have fundamentally
changed our understanding of hypertension, which has led to improved survival
and enhanced quality of life for millions who suffer from this disease."
The Stevo Julius Award for Education in Hypertension was established by the
Executive Committee of the International Society of Hypertension to honor Dr
Julius' critical contributions to hypertension education. The award is presented
to individuals who demonstrate distinction in the education of scientists and
specialists in hypertension or in hypertension education of the medical
profession at large. Stevo Julius, MD, is Professor of Medicine and Physiology
at the University of Michigan.
"I am delighted and honored by this year's choice of Drs. Stamler and Laragh as
recipients of the Stevo Julius Award for Education in Hypertension," said Stevo
Julius, MD. "Both Dr Stamler and Laragh are renowned figures in the field and
have made early and seminal contributions to the understanding of hypertension.
In addition, both have served as mentors to numerous scientists and remain
deeply engaged in promoting public knowledge about hypertension."
Page 3 of 41 Total Pages
Dr Laragh discovered the renin-angiotensin-aldosterone endocrine control system
and showed that it was a major factor in regulating normal blood pressure with
body sodium and potassium content. He proved that excess plasma
renin-angiotensin and aldosterone levels cause malignant hypertension and its
fatal vascular damage to the eyes, brain, heart and kidneys. He then implicated
milder excesses in plasma renin-angiotensin as the cause of most essential
hypertension and also as the vascular-toxic agent causing heart attack, heart
failure, or stroke in
them. Dr Laragh established three ways to block plasma renin system activity at
three different sites: beta blockers, saralasin (the first angiotensin receptor
blocker, or ARB), and teprotide (the first angiotensin converting enzyme
inhibitor, or ACE inhibitor). Dr Laragh's research thus provided new
understanding of the relationship between the renin system, high blood pressure
and cardiovascular disorders -- and thereby also revolutionized treatments of
these disorders.
Throughout his career, Dr Stamler has led several landmark studies in the
causation and prevention of major cardiovascular diseases, and their key risk
factors, including high blood pressure. Some of these are the Michael Reese
estrogen trial, the Chicago Coronary Prevention Evaluation Program, the National
Diet-Heart Study, the Multiple Risk Factor Intervention Trial, the Hypertension
Detection and Follow-Up Program trial, the Systolic Hypertension in the Elderly
trial, the Primary Prevention of Hypertension trial, and the DASH trials on the
effects of dietary patterns and of salt on blood pressure. Dr Stamler
spearheaded pivotal Chicago population studies, which have followed 4500 adult
men and women for over 25 years and led to critical new understanding about the
relationships among lifestyles, risk factors, and mortality from heart disease
and stroke. Dr Stamler also developed the Chicago Coronary Prevention Evaluation
Program, the first multi-factor primary prevention trial of cardiovascular
disease ever conducted, and the international cooperative INTERSALT and INTERMAP
studies of 15 000 adults elucidating the influences of multiple dietary factors
on blood pressure.
"On behalf of the International Society for Hypertension and Novartis, I
consider it an honor that Dr Laragh and Dr Stamler have accepted this year's
award. I cannot think of two more worthy individuals. Both Drs Laragh and
Stamler have made discoveries which have paved the way to advancements in
prevention and treatment, leading to improved longevity of human life. They
uphold the values and leadership for which this award was originally
established," said Professor A. Mimran, President of International Society of
Hypertension.
Novartis, the maker of the antihypertensive Diovan(R) (valsartan), is committed
to future developments in hypertension and cardiovascular conditions. To this
end, Diovan is supported by the world's largest clinical trial programme for an
ARB. The program includes the recently completed Val-HeFT trial (patients with
heart failure) and three major ongoing multinational morbidity and mortality
trials: VALUE (high risk hypertensive patients); 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 "world leader in cardiovascular research and treatment" and
"committed to future developments in hypertension and cardiovascular
conditions", "world's largest clinical trial programme for an ARB" 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
Page 4 of 41 Total Pages
that the aforementioned data will result additional regulatory approvals for
Diovan or in increased sales of Diovan. 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 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.
# # #
Notes to Editors:
John Laragh, MD
John Laragh, MD, Professor of Medicine and Director of the Cardiovascular Center
at the New York Presbyterian Hospital-Cornell Medical Center, founded the
American Society of Hypertension in 1985. In founding the Society, he was joined
by 16 other world famous clinicians and scientists in an effort to evaluate the
vast accumulation of data on hypertension and to provide an independent forum
for those involved in high blood pressure research.
Dr Laragh also founded the first Hypertension Center and served as Chief of
Nephrology and Vice-Chairman of the Board of Trustees at Columbia-Presbyterian
Medical Center before returning to New York Hospital-Cornell in 1975. From
1986-1988, Dr Laragh also served as the president of the International Society
of Hypertension.
Dr Laragh has been the recipient of a number of prestigious awards, including
the Stouffer Prize of the American Heart Association (1969), the JP Peters Award
of the American Society of Nephrology (1990), the Robert Tigerstedt Award from
the American Society of Hypertension (1990), and the Distinguished Achievement
Award from the Council for High Blood Pressure Research of the American Heart
Association. Throughout the past 40 years, Dr. Laragh is among the most
frequently cited scientists in cardiovascular disease. He has also published
over 900 papers, including the two volume reference text, Hypertension:
Pathophysiology, Diagnosis, and Management.
Dr Laragh earned his Medical Degree from Cornell University Medical College in
1948. He is married to his long time collaborator, Dr Jean Sealey, the
distinguished biochemist. They spend leisure time at their homes in Florida and
Southampton, New York.
Page 5 of 41 Total Pages
Jeremiah Stamler, MD
Jeremiah Stamler, MD, is an Emeritus Professor and Lecturer in the Department of
Preventive Medicine at Northwestern University's Feinberg School of Medicine in
Chicago. Dr Stamler served as the first Chair of the Department of Preventive
Medicine at Northwestern University School of Medicine (1972-1986), held the
distinguished position of Dingman Professor of Cardiology at the Medical School
(1973-1990) and served as the Chairman of the Department of Community Health and
Preventive Medicine at Northwestern Memorial Hospital (1973-1985).
Dr Stamler has been honored with several prominent awards, including the
Distinguished Service Award from the American College of Cardiology (1985), the
American Heart Association's Gold Heart Award (1992), and the David E. Rogers
Award from the Association of American Medical Colleges (2000). In addition, he
has published over 1000 articles in such leading journals as Circulation and
Hypertension.
Dr Stamler earned his Medical Degree from State University of New York,
Downstate Medical Center (Long Island College of Medicine) in 1943 and his
undergraduate degree from Columbia University in 1940. He was married to the
late Rose Stamler, internationally renowned researcher in cardiovascular
epidemiology and prevention.
# # #
Page 6 of 41 Total Pages
[CIBA VISION LOGO]
News Release
CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, GA 30097-1556
FOR MORE INFORMATION:
Kristie Madara (678) 415-3367
Kristie.madara@cibavision.novartis.com
Federal District Court Rules in Favor of Wesley Jessen, Grants Injunction in
Patent Infringement Case Filed Against Bausch & Lomb
Action Enjoins Sale of PureVision(TM) Contact Lenses
ATLANTA, June 26, 2002 - CIBA Vision Corporation, the eye care unit of Novartis
AG (NYSE: NVS), announced today that the United States District Court for the
District of Delaware ruled in favor of the company's wholly-owned subsidiary,
Wesley Jessen Corporation, in a patent infringement lawsuit filed against Bausch
& Lomb (NYSE: BOL).
The lawsuit, which was filed on May 3, 2001, claimed that Bausch & Lomb's
PureVision product infringes Wesley Jessen's U.S. Patent No. 4,711,943, issued
to Thomas Harvey III (the Harvey patent), which covers various silicone hydrogel
materials for contact lenses.
The Court ruled in favor of Wesley Jessen and affirmed that the patent is valid,
enforceable and infringed. The Court ordered Bausch & Lomb to discontinue the
manufacture and sale of its PureVision contact lenses effective immediately in
the United States. Bausch & Lomb cannot resume manufacture or sale of the
product within the Unites States at least until 2005 when the Harvey patent
expires.
Currently, PureVision lenses are only manufactured in the United States, which
means Bausch & Lomb's ability to supply this product to its international
markets may be affected.
-MORE-
"This is the outcome we expected," said Scott Meece, vice president and general
counsel for CIBA Vision. "We were quite confident in the validity of this patent
and the infringement by Bausch & Lomb and are extremely pleased with the speed
with which this case was heard and resolved." In addition to this lawsuit filed
on behalf of Wesley Jessen, CIBA Vision has had litigation pending against
Bausch & Lomb since 1999 for infringement of four U.S. patents that protect its
Page 7 of 41 Total Pages
breakthrough Focus(R) NIGHT & DAY(TM) technology, which allows 30 nights of
continuous wear. The cases in the U.S. were initially delayed because of Bausch
& Lomb's attempts to invalidate CIBA Vision's patents in four reexamination
proceedings before the United States Patent & Trademark Office (USPTO). After
Bausch & Lomb exhausted all options with the USPTO, all four patents were issued
again in November 2000, confirming the patents' validity and illustrating the
pioneering nature of CIBA Vision's inventions. CIBA Vision has also initiated
litigation against Bausch & Lomb in several other countries. If CIBA Vision
prevails in the U.S. case, Bausch & Lomb's PureVision lenses will remain off the
market until at least 2014.
"We are just as confident that we will prevail in our remaining patent
infringement cases against Bausch & Lomb," added Meece. "We are eager to go to
trial with our suits in the U.S., Australia and Germany, and to continue to
protect CIBA Vision's breakthrough inventions."
With worldwide headquarters in Atlanta, CIBA Vision is a global leader in
research, development and manufacturing of optical and ophthalmic products and
services, including contact lenses, lens care products and ophthalmic surgical
products. CIBA Vision products are available in more than 70 countries. For more
information, visit the CIBA Vision web site at www.cibavision.com.
CIBA Vision is the eye care unit 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 ongoing 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 72,600 people and operate in more than 140 countries around the
world. For further information, please consult www.novartis.com.
Forward-Looking Statement
The foregoing statement contains forward-looking statements that involve known
and unknown risks, uncertainties and other factors that may cause the actual
results to be materially different from any future results, performance, or
achievements expressed or implied by such statements. The statement references
patent litigation filed by CIBA Vision and our views on the nature and
likelihood of success of that litigation. The statement reflects the view of the
Company as of today. It is impossible to predict with certainty the outcome of
patent litigation and the risks presented thereby. Should one or more of these
risks or uncertainties materialize, actual results may vary materially from
those described herein as anticipated, believed or expected.
# # #
Page 8 of 41 Total Pages
[NOVARTIS LOGO] 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
Lescol(R) shown to reduce risk of serious cardiac events following surgery to
open constricted coronary arteries
Journal of the American Medical Association publishes landmark trial findings
Basel, Switzerland, 25 June, 2002 - Treatment with the cholesterol-lowering
medication Lescol(R) 80 mg (fluvastatin sodium), routinely initiated shortly
after a first angioplasty(a procedure to clear narrowed arteries), significantly
reduced the chances of a second serious cardiac event by 22% - even in patients
with normal cholesterol levels, according to the results of the landmark Lescol
Intervention Prevention Study (LIPS) published in today's edition of the Journal
of the American Medical Association (JAMA).The results of LIPS, which was the
first prospective statin study in this setting, may have major implications for
the 1.8 million patients annually who undergo angioplasty procedures(i).
Novartis plans to use the LIPS findings to broaden the indication for Lescol.
LIPS provides us with the scientific foundation to change the way we treat
patients who undergo percutaneous coronary intervention (PCI), such as
angioplasty or other similar procedures," commented lead author and principal
investigator Patrick Serruys, MD, PhD, Professor of Interventional Cardiology at
Erasmus Medical Centre, University Hospital, Rotterdam, The Netherlands.(ii)
"The study supports early intervention with fluvastatin in post-PCI patients,
regardless of cholesterol levels, to help prevent fatal and non fatal cardiac
events such as heart attacks and coronary surgery."
LIPS demonstrated that, in every 19 people treated for four years, that Lescol
prevented one fatal or non-fatal major adverse cardiac event. The study
population had an average LDL cholesterol level of 132 mg/dL [3.4 mmol/L], at
entry. Hence, half of the patients had a baseline cholesterol level within the
normal range. The risk reduction following Lescol therapy was similar
irrespective of baseline cholesterol levels. Because of this, the authors
concluded that statin therapy after PCI should be based on an overall risk
assessment of the patient, and not just baseline cholesterol levels.
LIPS is the first prospective, randomised, placebo-controlled trial to evaluate
the effects of a statin - specifically Lescol - exclusively in patients who have
had a first PCI. These patients represent a population with early-stage coronary
heart disease, who are at high risk of a second major adverse cardiac event.
While 90% of the 1.8 million patients who undergo PCI have immediate improvement
in chest pain (angina), 66% of patients die or have a cardiac event within 10
years after surgery.(2)
Page 9 of 41 Total Pages
LIPS involved 1677 patients recruited from 57 centres in 10 countries (Europe,
Canada and Brazil) for four years. The study examined the time to first major
adverse cardiac event, following a first PCI. Major adverse cardiac events were
defined as cardiac death, nonfatal heart attack, coronary artery bypass grafting
or repeat PCI. Patients were randomised to receive either Lescol 80 mg/day (40
mg twice daily) or placebo before hospital discharge after their first PCI
coronary surgical procedure.(1)
The study demonstrated that Lescol 80mg (40mg twice daily) significantly reduced
the risk of major adverse cardiac events by 22%, as compared with placebo
(p=0.01).(2) In addition, in certain high-risk patients, the benefits of Lescol
were even more profound. Patients with diabetes, experienced a 47% reduction in
the risk of a serious cardiac event,(2) as compared with placebo (p=0.04). The
study also found high-risk patients with multi-vessel disease, experienced a 34%
reduction in the risk of a major cardiac event, when compared with placebo
(p=0.01).(2) Patients with or without a stent, experienced similar benefits when
taking Lescol therapy.2 Of the patients treated with Lescol, those with unstable
angina experienced a greater risk reduction than those with stable angina (28%
versus 20%, respectively). Levels of harmful LDL cholesterol were significantly
reduced with Lescol to mean levels below 100 mg/dL (2.6 mmol/L) throughout the
course of the study. The LIPS data thus support the National Cholesterol
Education Program Adult Treatment Panel III guidelines to lower LDL cholesterol
to below the target level of 100 mg/dL (2.6 mmol/L) in all patients after a
PCI.(2)
The data also underscored the excellent safety profile of Lescol: there were no
significant elevations of creatine phosphokinase (CPK) above 10x ULN over the
three to four years of follow up. Elevated CPK is an indication of muscle
breakdown and is a potential side effect of statin therapies. These safety data
match those from a recent analysis involving more than 9000 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
placebo.(3)
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-cholesterol.(4)
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 "may have major implications", "plans to use", "excellent
safety profile", "provide 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 data will result in
the commercialisation or continued commercialisation or broadening of approved
indication for Lescol 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 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 10 of 41 Total 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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
--------------------
1 Ruygrok PN, de Jaegere PT, van Domburg RT, et al. Clinical outcome 10 years
after attempted percutaneous transluminal coronary angioplasty in 856
patients. J Am Coll Cardiol 1996;27:1669-77.
2 Patrick WJC Serruys, MD, PhD, et al. Fluvastatin for Prevention of Cardiac
Events Following Successful First Percutaneous Coronary Intervention. Draft
Manuscript. JAMA. June 26, 2002.
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-Releases Delivery System: A Pooled Analysis. Clinical Therapeutics
2001, No 2, Vol 23, p177-192.
# # #
Page 11 of 41 Total Pages
[NOVARTIS LOGO] Novartis Ophthalmics, Inc.
Media Relations
11695 Johns Creek Parkway
Duluth, Georgia 30097
USA
Tel 770-905-1020
Fax
E-mail: jan.mcclure
@pharma.novartis.com
MEDIA RELEASE
Novartis Ophthalmics teams with Carter Center to fight painful, blinding
diseases
Atlanta, 19 June 2002 - Novartis Ophthalmics, North America, today announced a
pilot program to aid former President Jimmy Carter and The Carter Center in
their work to prevent trachoma, a chronic bacterial infection that is the
world's leading cause of preventable blindness, and river blindness, caused by a
parasite transmitted by the bite of black flies.
In addition to a $50,000 donation to the Carter Center to fight blindness,
Novartis Ophthalmics will donate supplies of Eye Scrub(R) cleanser, currently
being used during and after trachoma surgeries in a pilot program in Ethiopia.
The inflammation of trachoma leads to trichiasis, or in-turned eyelashes, which
painfully abrade patients' corneas. If trichiasis is not surgically corrected,
the disease leads to permanent blindness. The World Health Organization (WHO)
estimates that trachoma already has blinded, or severely disabled 6 million
people.
146 million people worldwide need medical treatment for trachoma, which
flourishes where hygiene is poor. WHO and partner organizations have developed a
strategy called SAFE (Surgery, Antibiotics, Face washing, Environmental hygiene)
to combat the disease.
"In areas with limited access to clean, safe water, post-operative complications
are common. Eye Scrub could improve the outcome of eye surgeries for the
neediest patients," said Dan Myers, president of Novartis Ophthalmics. "These
surgeries are done not only to save villagers from going blind, but also to end
the painful irritation of trichiasis. Sterile equipment and supplies are limited
in these countries. Eye Scrub is packaged as a sterile, individually wrapped pad
that does not require water."
Novartis Ophthalmics, North America, which is based in Atlanta, will announce
the pilot program at a dinner on Wednesday, June 19, at The Carter Center
honoring President and Mrs. Carter and their commitment to vision-related health
projects around the world. During the evening, President Carter will give
Atlanta's leading ophthalmologists an overview of the Carter Center's health
projects as well as an update on health conditions in Cuba, where he recently
traveled.
Page 12 of 41 Total Pages
"Due to the efforts of President and Mrs. Carter, The Carter Center is a `light
of hope' beaming throughout the world for millions of impoverished people,"
Myers said. "Novartis Ophthalmics is very pleased to be able to join forces with
The Carter Center in helping people retain their sight."
Novartis Ophthalmics, maker of Visudyne(R), Rescula(R), Zaditor(TM) and other
ophthalmic pharmaceuticals, is also a partner with Prevent Blindness Georgia in
outreach programs to test children for lazy eye and to screen the homeless for
eye glasses.
About Novartis Ophthalmics
With worldwide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a
global leader in research, development and manufacturing of leading ophthalmic
pharmaceuticals that assist in the treatment of glaucoma, age-related macular
degeneration, eye inflammation, ocular allergies and other diseases and
disorders of the eye. Novartis Ophthalmics products are available in more than
110 different countries. The North American headquarters is based in Atlanta,
Ga. Novartis Ophthalmics has production sites in Switzerland, France and Canada.
For more information, please go to the web site www.novartisophthalmics.com/us.
About Novartis
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 72,600 people and
operate in over 140 countries around the world. For further information please
consult www.novartis.com.
# # #
Contact
Jan McClure, Director, Corporate Communications, Novartis Ophthalmics
Phone: +1 770.905.1010
Fax: +1 770.905.1510
Email: jan.mcclure@pharma.novartis.com
Page 13 of 41 Total Pages
[NOVARTIS LOGO] Investor Relations Novartis International AG
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 secures first marketing approval for breakthrough asthma drug as
Australia approves Xolair(R)
Basel, 18 June 2002 - Novartis has today welcomed a decision by the Therapeutic
Goods Administration (TGA) in Australia to approve the new anti-IgE therapy
Xolair(R) (omalizumab)* for treating adults and adolescents with moderate
allergic asthma. This represents the first marketing approval anywhere in the
world so far for Xolair.
The decision comes after the Australian Drug Evaluation Committee agreed that
Xolair should be indicated for the management of adult and adolescent patients
with moderate allergic asthma who are already being treated with inhaled
steroids and have raised levels of serum immunoglobulin E (IgE).
Thomas Ebeling, CEO of Novartis Pharma AG, said: "We are delighted by this
approval, which means that asthma patients are a step closer to experiencing the
benefits of this new treatment. Xolair seems to offer a unique method to enhance
the control of their disease by targeting a root cause of allergic asthma."
Xolair - which was developed under an agreement between Novartis Pharma AG,
Genentech, Inc. and Tanox, Inc. - is a monoclonal antibody and the first agent
to specifically target IgE. It works by binding to circulating IgE and
preventing it from attaching to mast cells. Without IgE bound to mast cells, the
presence of an allergen will not cause the release of chemical mediators like
histamine and leukotrienes, which lead to the symptoms and inflammation of
allergic asthma. Xolair is administered every two to four weeks subcutaneously
(i.e. by injection under the skin), at a dose depending on the patient's body
weight and IgE level.
Meanwhile, submissions for the approval of Xolair are proceeding in a number of
other important markets. In the US, Genentech and Novartis are planning to
submit an amendment to the Biologics License Application for Xolair to the Food
and Drug Administration in the fourth quarter of 2002. The content of this
amendment will address requests for additional information made by the FDA in a
Complete Response letter issued in July 2001, and the companies expect that data
from ongoing trials will satisfy those requests.
-------------
* In the US: Xolair(TM)(omalizumab)
Page 14 of 41 Total Pages
The foregoing press release contains forward-looking statements which can be
identified by terminology such as "are proceeding", "planning to submit", "will
address", "expect that", or similar expressions, or by discussion of potential
additional approvals of Xolair. 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 can be no certainty that Xolair
will be approved in any other market. Management's expectation regarding the
commercial potential of Xolair 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
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.
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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com
# # #
Page 15 of 41 Total Pages
[NOVARTIS LOGO] 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
Starlix(R) (nateglinide) significantly improves glycaemic control in metformin
patients with type 2 diabetes
Starlix(R)as an add-on to metformin significantly reduces HbA1c in a safe and
well-tolerated manner
Basel, 17 June 2002 - New data presented today at the American Diabetes
Association (ADA) annual meeting in San Francisco suggest that Starlix(R)
(nateglinide) improves glycaemic control in a safe and well-tolerated manner in
patients whose type 2 diabetes is inadequately controlled by taking metformin
alone. These new data, obtained in a real-world setting, are in line with a
double-blind clinical study published in May in Diabetes Obesity and
Metabolism(1).
The new results are particularly significant because improved glycaemic control,
as measured by a reduction of HbA1c levels, may lead to a dramatic lowering of
deaths and complications from diabetes. Even a 1% reduction in HbA1c can
correlate to a 21% decrease in deaths from diabetes and a 14% decrease in heart
attacks(2). Since both fasting and post-meal blood glucose contribute to HbA1c,
the combination of metformin (which acts on fasting blood glucose) and Starlix
(which acts on post-meal blood glucose), reduces HbA1c more than either agent
alone. In the new studies, reductions in HbA1c were even seen in patients who
were close to their target blood glucose levels. This suggests that even those
metformin patients near to target may benefit from the addition of Starlix to
their regimen and the reduced risk of death and complications that is associated
with improved glycaemic control.
"This study takes what we know about the efficacy of Starlix in clinical trials
to where it matters most - a real-world setting," said Ken Hershon, MD, FACE,
FACP, Director of Research, Northshore Diabetes and Endocrine Associates. "Here,
we found that nateglinide reduced mealtime glucose spikes and overall blood
glucose just as well or even better than it did in controlled clinical trials."
The new US study(3) involved 83 type 2 diabetes patients inadequately controlled
on metformin monotherapy (HbA1c 7.0-9.5%). For 12 weeks, these patients took 120
mg nateglinide before meals, in addition to their usual dose of metformin. The
results showed that 70% of the patients responded to nateglinide therapy
(decrease in HbA1c of at least 0.5%). The mean reduction in HbA1c over the 12
weeks was 0.8%. Plasma glucose two hours after a standard breakfast was reduced
by a mean of 2.7 mmol/l. Nateglinide was well-tolerated and hypoglycaemia was
confirmed by a low blood glucose level in only three patients (3.6%).
Page 16 of 41 Total Pages
These clinical data obtained in a real-world setting are in line with the
results of a randomised controlled trial1 published in the current issue of
Diabetes, Obesity and Metabolism. This trial involved 467 type 2 diabetes
patients who were stabilised on high-dose metformin (=>1500 mg/day) and who had
an HbA1c of 6.8-11%. Patients were randomised to receive 60 mg nateglinide, 120
mg nateglinide, or placebo before main meals, in addition to taking 2000 mg
metformin twice daily, for 24 weeks.
The trial results showed that the addition of Starlix to metformin monotherapy
resulted in a significant reduction in HbA1c compared with placebo. At the end
of the study HbA1c had been reduced by a mean of 0.6% in patients taking 120 mg
nateglinide. Patients with high HbA1c at baseline had the greatest reduction in
HbA1c (mean of -1.4%). Starlix was well tolerated with mild cases of
hypoglycaemia being the only treatment-related event so far: hypoglycaemia was
confirmed in only five patients (3.1%) taking the 120 mg dose and in none of the
patients taking the 60 mg dose.
Similar findings were obtained in a study recently performed in clinical
practice in the UK.(4) This UK study involved 214 patients whose type 2 diabetes
was treated with metformin but poorly controlled (HbA1c 7.2-9.3%). These
patients were given an additional 120 mg nateglinide before main meals for 12
weeks. At the end of the study, HbA1c had been reduced by a mean of 0.7% and
plasma glucose two hours after a standard breakfast by a mean of 2.4 mmol/l.
Starlix was well tolerated in patients, with symptoms suggestive of
hypoglycaemia reported in 15% of patients.
The data from these three studies confirm that Starlix is effective and
well-tolerated and can bring about a significant reduction in HbA1c in patients
who are inadequately controlled on metformin alone. Many type 2 diabetes
patients can initially achieve adequate glycaemic control with a single oral
anti-diabetic drug like metformin, combined with diet and lifestyle changes.
However, as type 2 diabetes progresses, most patients require the addition of a
second agent. Starlix is a useful adjunct to metformin monotherapy as it is
well-tolerated and has a complementary pharmacological action.
Type 2 diabetes is caused by a combination of reduced insulin secretion and
reduced sensitivity of the body's cells to insulin (insulin resistance).
Metformin reduces hepatic (liver) glucose production and insulin resistance and
acts primarily to reduce fasting blood glucose. In contrast, nateglinide acts
primarily on post-prandial blood glucose. When taken before a meal, nateglinide
rapidly stimulates a short burst of insulin secretion from pancreatic
(beta)-cells. This restores the early insulin secretion that is lost in people
with type 2 diabetes and prevents the post-meal glucose spikes characteristic of
the condition. Starlix duration of action is very short, minimizing the risk of
severe or long-lasting hypoglycaemia. The combination of metformin and Starlix
reduces HbA1c more than either agent alone.
The forgoing press release contains forward-looking statements which can be
identified by terminology such as "improves", "suggest that", "improve", "may
benefit", "enhances" 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
any product 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 protection and
competition in general.
Page 17 of 41 Total 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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com. For further information on type 2 diabetes,
visit www.diabetesandhealth.com. Novartis in-licensed nateglinide from Ajinomoto
Co., Inc. in 1993.
References
1. Marre M, Van Gaal L, Usadel K-H, Ball M, Whatmough I, Guitard C.
Nateglinide improves glycaemic control when added to metformin monotherapy:
results of a randomized trial with type 2 diabetes patients. Diabetes,
Obesity and Metabolism 2002; 4: 1-10.
2. Stratton IM, Adler AI, Neil AW, Matthews DR, Manley SE, Cull CA, Hadden D,
Turner RC, Holman RR. Association of glycaemia with macrovascular and
microvascular complications of type 2 diabetes (UKPDS 35): prospective
observational study. BMJ 2000; 321: 405-412.
3. Baron M, Mager RR, Vyas KH, Purkayastha DD. Nateglinide (Starlix)
effectively lowers HbA1c through reductions in post prandial glucose in
subjects with type 2 diabetes mellitus. Abstract presented at ADA Annual
Meeting, date, 2002.
4. Weaver JU, Robertson DA, Atkin SL. Nateglinide alone and as add-on therapy
to metformin in UK clinical practice: a 12-week study. Diabetic Medicine
2002; 19 (Suppl 2): 112-115.
# # #
Page 18 of 41 Total Pages
[NOVARTIS LOGO] Investor Relations Novartis International AG
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 -
Data suggest that Prexige(TM)(lumiracoxib), a new COX-2 inhibitor, offers strong
efficacy
Latest results additionally confirm Prexige(TM)is well-tolerated with
gastrointestinal safety superior to NSAIDs
Basel, 13 June 2002 - Highlights from key Phase II studies presented for the
first time at EULAR, the European League Against Rheumatism annual congress,
Stockholm, demonstrate that Prexige(TM) (lumiracoxib, COX189), a new innovative
investigational COX-2 selective inhibitor, has efficacy equal to the current
European "gold standard", diclofenac, in the treatment of patients with
arthritis and pain. Additional data presented at EULAR confirm Prexige(TM) is
well tolerated, and its gastrointestinal safety profile is superior to
non-steroidal anti-inflammatory drugs (NSAIDs) in this patient group. All
results to date support the potential use of Prexige(TM) in the treatment of
symptoms of arthritis and pain.
NSAIDs are commonly used for treating pain associated with arthritis. However,
they are associated with gastrointestinal (GI) ulcers and bleeding, due to
non-selective inhibition of cyclooxygenase (COX). The Phase II data with
Prexige(TM) shows it to be highly effective in the treatment of the symptoms of
arthritis and pain, while demonstrating improvements in safety and tolerability,
including GI safety, beyond traditional NSAIDs.
Results of an exploratory analysis of a large multinational study of 583
patients(iii) confirm the clinical relevance of the findings previously
presented by Schnitzer, et al.(iv) The assessment of the responder rate of
Prexige(TM) in osteoarthritis (OA) pain show that Prexige(TM) at 400mg once
daily (od) is highly effective for the treatment of patients with OA. These
findings suggest that Prexige(TM) provides the same strong efficacy as high
doses of diclofenac (75mg twice a day) in treatment response defined as a 20%
reduction in OA pain intensity based on the visual analog scale measure.
Commenting on the results, Jorg Reinhardt, Head of Development, Novartis Pharma
AG, said: "These data suggest that Prexige(TM) is a highly efficacious COX-2
selective inhibitor. Prexige(TM) has been shown to be as efficacious as the
"gold standard" treatment for arthritis, which is very encouraging news in the
development of new treatments in this therapy area."
Page 19 of 41 Total Pages
A second study, by Codreanu, et al.(v), compared the safety and tolerability of
Prexige(TM) to ibuprofen and celecoxib, over 3 months. The study investigated
upper gastrointestinal safety and tolerability in 1042 OA patients treated over
13 weeks. The results indicate that at both doses (200 mg od and 400 mg od)
Prexige(TM) showed a superior GI safety and tolerability profile compared with
ibuprofen. With respect to the occurrence of gastroduodenal ulcers, Prexige(TM)
was statistically superior to ibuprofen (p<0.01). The study showed that 15.7% of
patients in the ibuprofen group experienced ulcers compared with 4.3% and 4.0%
in the Prexige(TM) groups (200 mg od and 400 mg od respectively), which was
comparable to the celecoxib group (3.2%) in 1011 patients.
A further set of studies, conducted by Scott, et al.(vi,vii), and one additional
study by Rordorf, et al.(viii), investigated the efficacy and safety, and
explored the pharmacokinetics and pharmacodynamics of Prexige(TM) at various
dosing regimens. Overall, Prexige(TM) was well tolerated and efficacious, and no
clinically significant changes in laboratory parameters were noted. In addition,
dose frequency did not appear to influence overall pain scores and no effect on
platelet aggregation was observed. From these studies, it can be concluded that
a single, daily dose of Prexige(TM) at 800 mg (2-4 times the expected
therapeutic dose) is safe and well tolerated.
Commenting on the wealth of trial data presented at EULAR, Thomas Ebeling, CEO,
Novartis Pharma AG, said, "We are all very excited by the progress made by
Prexige(TM) during this clinical trial phase. Our data show we can offer
efficacy of the most powerful NSAIDs currently available with superior GI
safety."
The foregoing press release contains forward-looking statements that can be
identified by terminology such as "suggests that", "showed", "seems superior",
"indicate", "should be", 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, including
the results of clinical trials, 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.
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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 20 of 41 Total Pages
--------------------
1 A Moore, et al., Responder rate of COX189 in osteoarthritis: a
multinational study. Abstract 265presented at EULAR, 2002.
1 T Schnitzer, et al., Efficacy and safety of COX189 in osteoarthritis: a
multinational study. Abstract 1616 presented at ACR, 2000.
1 C Codreanu, et al., Improved upper gastrointestinal (UGI) safety and
tolerability of a new coxib, COX189 compared with ibuprofen in
osteoarthritis patients. Abstract 226 presented at EULAR, 2002.
1 G Scott, et al., Pharmacokinetics and pharmacodynamics of COX189 in
patients with knee or hip primary osteoarthritis. Abstract 233 presented at
EULAR, 2002.
1 G Scott, et al., Dose Escalation study to assess the safety, tolerability,
pharmacokinetics and pharmacodynamics of COX189 in healthy subjects.
Abstract 300 presented at EULAR, 2002.
1 C Rordorf, et al., Steady state pharmacokinetics, pharmacodynamics, safety
and tolerability of COX189 in healthy subjects. Abstract 284 presented at
EULAR, 2002.
Page 21 of 41 Total Pages
[NOVARTIS LOGO] 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 announces recipients of Diabetes Award
Judging panel praises `outstanding' quality of nominations
Basel, 13 June 2002 - Novartis Pharma AG today announced the recipients of the
2002 Novartis Award in Diabetes. Four awards of USD 25 000 each will be given to
clinical investigators judged to have made exceptional contributions to the
field of diabetes.
The judging panel, comprised of independent internationally-recognised diabetes
experts, selected two recipients in each of the categories: Long-Standing
Achievement and Young Investigator.
Professor Eberhard Standl, Chairman of panel, said "we were extremely impressed
by the quality of the nominations this year. The recipients have conducted
outstanding research, crucial to advancing our knowledge of diabetes. Their
contributions have already had and will have a major impact on diabetes
treatment and on the quality of life of millions of people around the world
whose lives are affected by the disease".
The Long-Standing Achievement Awards will be presented to Professor Sir George
Alberti of the UK and Professor Daniel Porte of the USA for their exceptional
and sustained achievements in clinical research, education and clinical
practice.
o Professor Alberti is President of the International Diabetes Federation and
has worked with the World Health Organisation for many years, serving on
its Expert Advisory Panel since 1979. He is President of the Royal College
of Physicians, Professor of Medicine at the University of Newcastle and
Professor of Metabolic Medicine at Imperial College, London. Professor
Alberti has devoted many years of his career to the pursuit of raising
awareness of diabetes and the need for screening and more aggressive
management of the disease.
o Professor Daniel Porte is Professor of Medicine at the University of
California School of Medicine, Professor Emeritus of Medicine at the
University of Washington School of Medicine and Staff Physician at the VA
San Diego Health Care System. Professor Porte's career has spanned more
than 30 years of research in diabetes. He has published over 350
professional papers on topics as far-reaching and diverse as insulin action
in the central nervous system; beta cell dysfunction and preservation; and
the pathophysiology of impaired glucose tolerance.
Page 22 of 41 Total Pages
The Young Investigator Award recognises innovative patient-oriented research in
the fields of physiology, pathophysiology or epidemiology of diabetes and its
complications. Awards will be presented to Dr Riccardo Bonadonna of Italy and Dr
Kitt Petersen of the USA.
o Dr Riccardo Bonadonna is Assistant Professor at the University of Verona
Medical School. Dr. Bonadonna has published over 60 papers on topics such
as insulin and its metabolic effects.
o Dr Kitt Petersen is Assistant Professor of Internal Medicine and Assistant
Director of the General Clinical Research Center at Yale University School
of Medicine. Dr Petersen's work in the broad area of diabetes research has
focused on endocrinology, glucose metabolism, and insulin-resistance.
"We, at Novartis, honour this year's recipients for their personal and
professional commitment to diabetes," said Dr. James Shannon, Global Head of
Clinical Research and Development from Novartis. "We hope that the Novartis
Award in Diabetes will continue to inspire researchers from around the world to
strive for the highest standards in diabetes treatment and clinical research."
The Award recipients will be honoured at a gala Presentation Dinner at the
Hungarian National Gallery, to be held on September 2002, during the EASD in
Budapest.
Novartis Commitment to Diabetes
This international award is one of many activities that Novartis is supporting
to help increase awareness of and urgency for innovation in diabetes research,
education and clinical practice. Novartis is constantly exploring new approaches
for the treatment of type 2 diabetes and has recently launched Starlix(R)
(nateglinide), a novel insulin secretion agent. Starlix(R) is a derivative of
the amino acid D-phenylalanine and restores the physiological insulin secretion
pattern lost in people with type 2 diabetes, thereby preventing the mealtime
glucose spikes that are believed to increase the risk of long-term
complications. Novartis in-licensed nateglinide from Ajinomoto Co., Inc. in
1993.
About Novartis
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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
For further information on the Novartis Award in Diabetes, please visit the
Novartis Portal for Type 2 Diabetes www.diabetesandhealth.com.
# # #
Page 23 of 41 Total Pages
[NOVARTIS LOGO] 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
Estalis(R) HRT patch demonstrates positive effects on sexual functioning in
postmenopausal women in comparison with pills
Data also suggest menopausal women prefer patches to pills for the delivery of
hormone replacement therapy
Basel, 12 June 2002 - Preliminary study results published at the 10th World
Congress on Menopause in Berlin demonstrate that the use of Estalis(R)*
continuous, combined matrix HRT patch, has positive effects on psychosexual
functioning including mood, libido and orgasms. Endocrine markers were also
found to favor positively towards sexual function.
"Female sexual dysfunction - low libido, slow arousal, difficulty in reaching
orgasm - is a problem millions of postmenopausal women face and for which there
is a lack of treatment options", said Subir Roy MD, Lead Researcher and
Professor at the Department of Obstetrics and Gynecology, Keck School of
Medicine, University of Southern California, USA. Our preliminary results might
be the first step in providing a new solution for post-menopausal women".
The study was designed to compare the effect of continuous transdermal HRT with
two different oral HRT formulations on mood and libido in postmenopausal women.
Twenty-six women were randomized to an Estalis patch or an HRT pill and assessed
using serum endocrine markers and the Derogatis interview for sexual
functioning. At the end of the eight week study, the Estalis patch was
associated with a increase in ability to have orgasm, intensity of orgasm,
ability to have multiple orgasms, sense of control/timing of orgasm and a sense
of relaxation and well-being after orgasm, as compared with the two oral
therapies (p=0.05). Larger and longer investigations are underway to verify
these results.
A second HRT study, presented by Professor James Simon MD (Department of
Obstetrics and Gynecology, George Washington University, USA), concluded that
menopausal women preferred patches to pills, indicating that long-term
compliance may increase with the use of patches.
In the study, women were provided with a placebo patch and a placebo pill for
four weeks. Of the 186 participants, 81.2% rated the patch as `excellent',
`good' or `very good', whereas 7% gave it a `poor' rating. 37.1% preferred the
patch "a lot more" in comparison with 17.2% for the pill.
Page 24 of 41 Total Pages
*CombiPatch in the U.S.
Page 25 of 41 Total Pages
Novartis pioneered transdermal hormone replacement therapy in the 1980s to meet
the needs of peri- and post-menopausal women requiring relief from menopausal
symptoms and protection against osteoporosis. Menopausal symptoms include
declining sexual function, hot flushes and night sweats, disturbed sleep, memory
loss, as well as the risk for developing osteoporosis later in life. It is
estimated that by 2005, 36% of women will be over the age of 50 and have a
potential need for alleviation of distressing menopausal symptoms, which
compromise their quality of life.
This release contains certain forward looking statements which can be identified
by the use of forward looking terminology such as "suggest", "demonstrates/has
positive effects", "might be the first step in providing a new solution",
"associated with a significant increase' and "may increase", and by any
discussions or suggestions regarding potential future sales of Estalis or other
Novartis products. Such forward-looking statements involve known and unknown
risks, certainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantees that
Estalis, or other Novartis products will reach any particular level of sales.
Any such sales can be affected by, amongst other things, outcome of further
studies, uncertainties relating to 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 20-F filed with the Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, then actual
results may 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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 26 of 41 Total Pages
[NOVARTIS LOGO] 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 data show Glivec(R) as first-line treatment for chronic myeloid leukemia
maintains quality of life
o Head-to-head data show Glivec is nearly three times more effective as
first-line treatment for CML patients than interferon combination therapy
o Data comparing efficacy and quality of life with Glivec to interferon
combination therapy in newly diagnosed patients presented at meeting of
European Haematology Association
Basel, 7 June 2002 - Glivec(R) (imatinib)* provides newly diagnosed patients
with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the
chronic phase a significantly better quality of life (QoL) than does the
commonly used combination of interferon (IFN) plus chemotherapy [cytarabine
arabinoside, (Ara-C)], according to data presented at the 7th annual meeting of
the European Haematology Association (EHA) in Florence, Italy. The data were
derived from an analysis of results from the International Randomized Study of
Interferon vs. STI571 (IRIS), a large multicentre trial that demonstrated that
Glivec is nearly three times more effective in achieving a cytogenetic response
in the first-line treatment of newly diagnosed CML patients than the combination
therapy. In addition, Glivec significantly delayed the time to progression to
the more advanced stages of CML compared to IFN/Ara-C. These data also were
presented today at the EHA meeting.
"The ability to maintain a patient's quality of life is a critically important
factor in selecting any cancer therapy," said Elizabeth Hahn, Director of
Biostatistics at the Centre on Outcomes, Research and Education, Evanston
Northwestern Healthcare, Evanston, Illinois. "In an early analysis, the IRIS
study has shown that at the 12-month checkpoint, Glivec is significantly more
effective than the combination of IFN and Ara-C in patients with newly diagnosed
CML. These quality of life data demonstrate that Glivec offers an important
added benefit by enabling treatment of patients without significantly impairing
their lifestyles. And, a good quality of life suggests that patients are likely
to stay on treatment."
The quality of life assessment was based on the Functional Assessment of Cancer
Therapy--Biologic Response Modifiers (FACT-BRM) scale, a standardized QoL
questionnaire that evaluates physical, functional, social/family and emotional
well-being. The difference in quality of life was evident within one month after
start of treatment, during which patients on Glivec consistently scored higher
than those on the combination therapy.
Page 27 of 41 Total Pages
Clinical Data
The QoL study was part of IRIS, an open-label, Phase III trial that enrolled
1,106 patients in 177 centres in 16 countries. One study arm received Glivec at
400 mg/day by mouth; the other arm received the combination of IFN by
subcutaneous injection at 5 million IU/m2/day plus Ara-C 20 mg/m2/day by
intravenous infusion for 10 days each month. In this study, QoL was assessed
based on FACT-BRM at the beginning of treatment, and was re-evaluated monthly
for the first six months and every three months thereafter. A total of 1,049
patients completed at least one QoL assessment and 885 patients completed at
least six assessments: 486 in the Glivec arm and 399 in the IFN/Ara-C arm. The
average composite scores (Trial Outcome Index [TOI], measured from 0-108 highest
QoL) at 12 months were 84.3 for Glivec and 67.1 for IFN/Ara-C, a statistically
significant difference of 17.2 (p<0.001). These findings are clinically
relevant, having substantial impact on the future course of the disease.
Patients in the Glivec group were able to maintain their quality of life,
whereas those in the IFN/Ara-C group experienced a decline in QoL that was
evident within the first month of treatment.
The early results of the IRIS study also were presented at the EHA meeting. The
study suggested that Glivec was significantly more effective than the
combination therapy in achieving a cytogenetic response in the first-line
treatment of patients newly diagnosed with chronic phase CML. Complete
cytogenetic response, the elimination of the Philadelphia chromosome, is
regarded as the ultimate goal of CML treatment. The results presented were based
on data collected up to 12 months after the last patient was randomized; the
median follow-up was 14 months. The results showed that patients had achieved
major and complete cytogenetic responses of 84% and 69% (Ph<35%), compared with
patients in the IFN/Ara-C arm, who experienced major and complete cytogenetic
responses of 30% and 11.5%. The complete haematologic response rates were 96%
for the Glivec arm and 67% of the IFN/Ara-C arm.
"Both the IRIS data and the quality of life findings strongly support the use of
Glivec early in the course of CML," said Francois Guilhot, MD, Head of the
Department of Oncology, Haematology and Cell Therapy at Jean Bernard Hospital,
Poitiers, France. "These data provide very encouraging news to patients and
physicians alike. "
Last January, based on a review of the six-month positive results for Glivec, an
Independent Data Monitoring Board (IDMB) requested a change in the study
protocol that enabled patients receiving IFN/Ara-C to switch to Glivec if they
had not achieved a major cytogenetic response after one year of the combination
therapy.
At the time of this analysis, fewer than 1% of Glivec-treated patients crossed
over to the IFN/Ara-C therapy, compared with 39% of IFN/Ara-C-treated patients
who crossed over to Glivec due to insufficient efficacy or intolerance.
In the IRIS study, the safety profile with Glivec was similar to that of
previous Phase II studies, and was superior to that of the IFN/Ara-C combination
regimen. The most frequent adverse events with Glivec were mild to moderate
superficial oedemas, muscle cramps, skin rash and nausea. The most frequent
adverse events with IFN/Ara-C were nausea, fatigue, headache and diarrhea. In
the Glivec arm, only 2% and 0.7% of patients discontinued from the study or
crossed over the control arm for safety reasons, respectively. In contrast, in
the IFN/Ara-C arm, 6% and 23% of patients discontinued from the study or crossed
over for safety reasons, respectively.
Page 28 of 41 Total Pages
About Glivec
Glivec is one of the first oncology drugs that validate rational drug design
based on an understanding of how some cancer cells work. It is a signal
transduction inhibitor, which potentially interferes with the pathways that
signal the growth of tumor cells. It works by inhibiting the Philadelphia
chromosome, the abnormality that characterizes CML in most patients. To date,
Novartis has received marketing clearance for Glivec for the CML indication
worldwide.
In most countries where Glivec is approved, it is indicated for the treatment of
patients with Philadelphia chromosome-positive CML in blast crisis, accelerated
phase, or in chronic phase after failure of interferon-alpha therapy.
In February 2002, Glivec received approval from the US Food and Drug
Administration (FDA) for the treatment of patients with Kit (CD 117) positive
unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal
tumors (GISTs). Three months later, on 24 May 2002, Glivec received approval for
the GIST indication in the European Union. Glivec also is approved for the GIST
indication in Switzerland, where it was approved on 9 April 2002.
Contraindications and Adverse Events
In the second-line treatment of CML patients, the majority of patients treated
with Glivec experienced adverse events at some time. Most events were of mild to
moderate grade and treatment was discontinued for adverse events only in 2% of
patients in chronic phase, 3% in accelerated phase and 5% in blast crisis. 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.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "significantly more effective, " "significantly better, "
"suggests" and "important added benefit" 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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 29 of 41 Total Pages
Additional information can be found at www.novartisoncology.com and at
www.novartisoncologyvpo.com.
Page 30 of 41 Total Pages
[NOVARTIS LOGO] Novartis Pharmaceuticals
Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA
Tel +1- 973 781 8300
Internet Address:
http://www.pharma.us.novartis.com
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
FDA grants marketing clearance for Ritalin(R) LA, a once-daily formulation of
Ritalin(R) for ADHD that lasts through the entire school day
East Hanover, NJ, Dublin, Ireland, Warren, NJ, 6 June 2002 - Novartis
Pharmaceuticals Corporation (NYSE: NVS), Elan Corporation, plc (NYSE: ELN)
("Elan"), and Celgene Corporation (Nasdaq: CELG) announced today that the US
Food and Drug Administration (FDA) has granted marketing clearance for
Ritalin(R) LA (methylphenidate HCl) extended-release capsules for the treatment
of Attention-Deficit/Hyperactivity Disorder (ADHD). Ritalin LA, a new once-daily
formulation of Ritalin(R) (methylphenidate HCl), eliminates the need for a
mid-day dose during school. Ritalin LA uses SODASTM technology*, a proprietary
drug delivery technology of Elan. The medication is available in 20, 30 and 40
mg beaded capsules for oral administration.
"Ritalin LA represents an important advance in the treatment of ADHD," said
Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School
and Assistant Director of the Pediatric Psychopharmacology Research Program at
Massachusetts General Hospital. "It provides the rapid onset, and the proven
safety and efficacy of Ritalin in one, single morning dose. Ritalin LA is
effective in treating ADHD symptoms throughout the school day, eliminating the
need for children to take their medication while in school."
Each bead-filled capsule of Ritalin LA provides an immediate release of Ritalin
for rapid onset of action, and a second release of the medication approximately
four hours after administration. The bimodal release formulation of Ritalin LA
provides two peak concentrations of medication, mimicking twice-daily
administration of Ritalin, but with less fluctuation. Ritalin LA provides the
same rapid onset as Ritalin and its efficacy lasts throughout the school day.
Ritalin LA may be swallowed as whole capsules, or, for children who have
difficulty swallowing, it may be administered by sprinkling the beaded contents
on applesauce.
A double-blind, placebo-controlled study involving 134 patients, aged 6 to 12
years, demonstrated Ritalin LA to be effective in treating ADHD symptoms. In
this study, in which efficacy was evaluated by examining presence of ADHD
symptoms in home and school settings, Ritalin LA was administered once-daily at
individually titrated doses ranging from 10-40 mg/day for up to two weeks.
Efficacy was measured by the change from baseline in the Conners ADHD/DSM-IV
total subscale for teachers (CADS-T), a validated tool for the assessment of
ADHD symptoms by teachers. Results of the analysis demonstrated that Ritalin LA
was statistically superior to placebo in managing ADHD symptoms, including
symptoms of inattention and hyperactivity.
Page 31 of 41 Total Pages
Ritalin LA was proven to be safe and well tolerated. In a placebo controlled,
double-blind, parallel group study with 134 children, adverse events were
reported in 25% of treated patients compared with 24% in the placebo group. The
most commonly reported adverse events included anorexia, insomnia, sore throat,
headache and vomiting. Overall discontinuation rates were 1.5% for Ritalin LA
and 0% for placebo.
Ritalin LA is contraindicated in patients known to be hypersensitive to the drug
or to Ritalin, in patients with glaucoma, in patients with motor tics, and in
patients with a family history or diagnosis of Tourette's syndrome. In addition,
Ritalin LA is contraindicated during treatment with monoamine oxidase inhibitors
and should not be taken until at least 14 days after discontinuation of a
monoamine oxidase inhibitor. Ritalin LA should be given cautiously to patients
with a history of drug dependence or alcoholism.
ADHD is a neurobiologic disorder that interferes with an individual's ability to
regulate activity level and behavior, and sustain focus in developmentally
appropriate ways. It is the most studied childhood psychiatric disorder and is
supported by a substantial body of scientific evidence. Scientific research
indicates that ADHD may be related to disturbances in certain neurotransmitters
in the brain. Novartis supports only the proper diagnosis and treatment of ADHD.
Recognizing that no single treatment is perfect for everyone, Ritalin LA is
recommended as part of a comprehensive treatment regimen including behavior
modification and counseling.
Ritalin LA was developed by Elan's drug delivery division and will be supplied
to Novartis under an exclusive worldwide royalty and manufacturing agreement
between the companies. Novartis Pharmaceuticals Corporation has
commercialization rights to Ritalin LA in the US
Ritalin LA joins the Novartis ADHD product portfolio, which includes Ritalin,
Ritalin SR, and Focalin(TM) (dexmethylphenidate HCl). Celgene Corporation of
Warren, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding
Canada) license covering its intellectual property rights associated with
Ritalin LA as well as Focalin. Pursuant to an agreement between Novartis Pharma
AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals
Corporation markets Focalin in the US
The foregoing press release contains forward-looking statements that can be
identified by forward-looking terminology such as, "new", "important advance",
"to offer" or similar expressions. Such statements involve known and unknown
risks, uncertainties and other factors that may cause the actual results to be
materially different from any future results, performance, or achievements
expressed or implied by such statements. In particular, management's expectation
regarding the commercialization of Ritalin LA could be affected by amongst other
things, results from future clinical trials, 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 anticipated, believed, estimated or expected.
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.
Page 32 of 41 Total Pages
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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
Elan is a leading worldwide, fully integrated biopharmaceutical company
headquartered in Ireland, with its principal research, development,
manufacturing and marketing facilities located in Ireland and in the US Elan is
focused on the marketing of therapeutic products and services in neurology, pain
management, infectious disease, dermatology, oncology and the development and
commercialization of products using its extensive range of proprietary drug
delivery technologies. Elan shares trade on the New York, London and Dublin
Stock Exchanges. For further information, please feel free to visit the
Company's Web site at http://www.elan.com.
Celgene Corporation, headquartered in Warren, New Jersey, is an independent
biopharmaceutical company engaged primarily in the discovery, development and
commercialization of orally administered small molecule drugs for the treatment
of cancer and inflammatory diseases through gene regulation. Please feel free to
visit the Company's Web site at http://www.celgene.com.
*SODAS(TM) is a trademark of Elan Corporation, plc.
# # #
For complete prescribing information, please contact Gina Moran or Denise
Brashear of Novartis Pharmaceuticals at ++1- 973-781-8300.
Contact:
Regina Moran Denise Brashear
Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals Corporation
++1-973-781-5567 ++1-973-781-7336
regina.moran@pharma.novartis.com denise.brashear@pharma.novartis.com
Robert Hugin Emer Reynolds
Celgene Corporation Elan Corporation, plc
++1-732-271-4102 ++1-353-1-709-4000
rhugin@celgene.com emer.reynolds@elan.com
Jack Howarth
Elan Corporation, plc
++1-212-407-5740
jack.howarth@elan.com
Page 33 of 41 Total Pages
[NOVARTIS LOGO] Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA
Tel +1-973 781 8300
Internet Address:
http://www.pharma.us.novartis.com
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
Novartis launches new educational ADHD web site
"ADHDinfo.com" offers parents, school personnel and healthcare providers
reliable information, resources and support about ADHD
East Hanover, NJ, 4 June 2002 - Novartis Pharmaceuticals Corporation announced
today the availability of a new Attention-Deficit/Hyperactivity Disorder (ADHD)
online resource designed to provide reliable educational information about ADHD
to parents and healthcare professionals. The Web site, www.adhdinfo.com, was
previewed at the American Psychiatric Association (APA) 155th Annual Meeting in
Philadelphia, Pennsylvania in May.
"This valuable new resource provides families and healthcare professionals with
practical information about approaches to ADHD management and serves as an
important source for reliable information and support," said Timothy Wilens,
M.D., Associate Professor of Psychiatry, Harvard Medical School.
ADHDinfo.com is divided into 4 primary sections:
o Parents & Caregivers - provides information to help parents better
understand ADHD as well as tips and tools for helping children and teens
with ADHD cope in school and at home.
o School Personnel - outlines special educational considerations for
children with ADHD and discusses ways teachers and other school personnel
can work with parents to help children and teens with the disorder.
o Healthcare Providers - offers information about diagnosis and treatment of
ADHD as well as resources to learn up-to-date scientific information, such
as symposia schedules and listings of related journal publications.
o S.T.A.R.T. Now - offers information about a new program called Straight
Talk About Responsible Treatment (S.T.A.R.T.) Now. The S.T.A.R.T. Now
program is designed to educate teens with ADHD, their parents and school
officials about appropriate use of stimulant medications in the treatment
of ADHD.
"Education about ADHD plays a vital role in the overall comprehensive care of
this disorder," said Larry Perlow, M.D., Senior Vice President and General
Manager, Novartis Pharmaceuticals Corporation. "That's why Novartis has made
available this online resource to health care providers and families touched by
ADHD."
Page 34 of 41 Total Pages
ADHD is a neurobiologic disorder that interferes with an individual's ability to
regulate activity level and behavior, and sustain focus in developmentally
appropriate ways. It is the most studied childhood psychiatric disorder and is
supported by a substantial body of scientific evidence. Scientific research
indicates that ADHD may be related to disturbances in certain neurotransmitters
in the brain. Novartis supports only the proper diagnosis and treatment of ADHD.
The Novartis ADHD product portfolio includes Ritalin(R) (methylphenidate),
Ritalin SR, and Focalin(TM) (dexmethylphenidate HCl), a refined formulation of
Ritalin. Celgene Corporation (Nasdaq: CELG) of Warren, New Jersey, granted
Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering
its intellectual property rights associated with Focalin as well as Ritalin LA,
a once-daily form of Ritalin that is currently under review at the Food and Drug
Administration (FDA). Pursuant to an agreement between Novartis Pharma AG and
Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation
markets Focalin in the U.S.
In addition, Novartis Pharmaceuticals Corporation received an approvable letter
from the FDA for Ritalin LA in October 2001. Ritalin LA was developed by Elan
Corporation, plc's drug delivery division and will be supplied to Novartis under
an exclusive worldwide royalty and manufacturing agreement between the
companies. Novartis Pharmaceuticals Corporation has commercialization rights to
Ritalin LA in the U.S.
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 72 600 people and
operate in over 140 countries around the world. For further information. For
further information please consult http://www.pharma.us.novartis.com or
http://www.novartis.com.
# # #
Contact:
Regina Moran Denise Brashear
Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals Corporation
973-781-5567 973-781-7336
regina.moran@pharma.novartis.com denise.brashear@pharma.novartis.com
- OR -
Julie Bane
Feinstein Kean Healthcare
617-761-6762
jbane@fkhealth.com
Page 35 of 41 Total Pages
[NOVARTIS LOGO] Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA
Tel +1-973 781 8300
Internet Address:
http://www.pharma.us.novartis.com
MEDIA RELEASE o COMMUNIQUE AUX MEDIAS o MEDIENMITTEILUNG
Novartis introduces S.T.A.R.T. (Straight Talk About Responsible Treatment) Now
program to educate about appropriate use of ADHD medications
For free educational brochures, people can call toll-free 1-888-NOW-NOVA
or visit http://www.ADHDinfo.com
East Hanover, NJ, 4 June 2002 - Novartis Pharmaceuticals Corporation today
announced a new program designed to educate teens, parents and school officials
about appropriate use of stimulant medications in the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD). The program, called Straight
Talk About Responsible Treatment (S.T.A.R.T.) Now, launches with a brochure
series and web site designed to help ensure that ADHD medications are only taken
as prescribed by qualified healthcare providers.
The S.T.A.R.T. Now program contains information for children who have been
diagnosed with ADHD and who have been prescribed a stimulant medication as part
of their treatment plan, their parents, and school personnel involved in
administering medications at school. The brochures will be disseminated through
the National Association of School Nurses (NASN) and the content will be
available on the Internet at http://www.adhdinfo.com, Novartis' online resource
for ADHD information. People can also call toll-free 1-888-NOW-NOVA to request a
free copy of one or more of the brochures.
"The S.T.A.R.T. Now program provides valuable information about how to use and
store stimulant medications safely and correctly," said Judith Robinson,
Executive Director, National Association of School Nurses. "It is extremely
important to take steps towards ensuring appropriate use of any medication,
especially those that are sometimes administered in school. That is why we're so
pleased to be a part of this initiative."
S.T.A.R.T. Now was developed in consultation with the following organizations*:
o The Drug Enforcement Administration (DEA)
o The National Association of School Nurses (NASN)
o The National Council for Patient Information and Education (NCPIE)
o The National Institute on Drug Abuse (NIDA)
o The National Institute of Mental Health (NIMH)
Page 36 of 41 Total Pages
Stimulant medications are the most commonly prescribed treatment for ADHD and
are successful in treating symptoms in up to 90% of patients. Research suggests
that stimulants such as Ritalin enhance nerve-to-nerve communication in people
with ADHD by blocking the reuptake of the neurotransmitters, thereby making more
neurotransmitters available to boost the "signal" between neurons.
"As with all prescription medications, medications for ADHD must be taken only
as prescribed and handled appropriately. In order for this to happen, people
need to be equipped with easy-to-understand, reliable information about the
medications they are taking," said Larry Perlow, M.D., Senior Vice President and
General Manager, Commercial Operations, Novartis Pharmaceuticals Corporation.
"We are proud to offer S.T.A.R.T. Now and hope that in so doing, we're supplying
families with the information they need to get the best care possible."
ADHD is a neurobiologic disorder that interferes with an individual's ability to
regulate activity level and behavior, and sustain focus in developmentally
appropriate ways. It is the most studied childhood psychiatric disorder and is
supported by a substantial body of scientific evidence. Scientific research
indicates that ADHD may be related to disturbances in certain neurotransmitters
in the brain. Novartis supports only the proper diagnosis and treatment of ADHD.
The Novartis ADHD product portfolio includes Ritalin(R) (methylphenidate),
Ritalin SR, and Focalin(TM) (dexmethylpenidate HCl). Celgene Corporation
(Nasdaq: CELG) of Warren, New Jersey granted Novartis Pharma AG an exclusive
worldwide (excluding Canada) license covering its intellectual property rights
associated Focalin as well as Ritalin LA, a once-daily form of Ritalin that is
currently under review at the Food and Drug Administration (FDA). Pursuant to an
agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation,
Novartis Pharmaceuticals Corporation markets Focalin in the U.S.
In addition, Novartis Pharmaceuticals Corporation received an approvable letter
from the FDA for Ritalin LA in October 2001. Ritalin LA was developed by Elan
Corporation plc's drug delivery division and will be supplied to Novartis under
an exclusive worldwide royalty and manufacturing agreement between the
companies. Novartis Pharmaceuticals Corporation has commercialization rights to
Ritalin LA in the U.S.
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.
In keeping with this mission, Novartis Pharmaceuticals Corporation has a long
history of supporting education and mental health programs from organizations
such as the National Council on Patient Information and Education; the National
Alliance for the Mentally Ill; Children and Adults with Attention-Deficit/
Hyperactivity Disorder; and the Lab School of Washington. In an effort to
continue to provide innovative solutions to patient information and education,
the company has recently partnered with Oscar-winning producer Ann Michaels in
the production of Listen to the Children, a documentary film focused on
children's mental health within the United States.
Page 37 of 41 Total Pages
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 72 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.pharma.us.novartis.com or http://www.novartis.com.
NASN is a specialty nursing association dedicated to improving the health and
educational success of children and youth by developing and providing leadership
to advance school nurse practice and by establishing quality standards that
conform to clinical nursing practice standards. With more than 11,000 members,
50 affiliates nationwide and one overseas affiliate; NASN is committed to
providing high quality education and resources to keep school nurses informed of
the latest trends in school nursing practice. Furthermore, NASN benefits school
nurses by speaking as one voice nationally; by increasing the visibility of
school nursing; by advocating for minimum levels of preparation; by advocating
for manageable nurse to student ratios; and by providing a forum for discussion
of school health issues.
*These organizations do not endorse any particular products or companies.
# # #
Contact:
Regina Moran Denise Brashear
Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals Corporation
973-781-5567 973-781-7336
regina.moran@pharma.novartis.com denise.brashear@pharma.novartis.com
- OR -
Julie Bane
Feinstein Kean Healthcare
617-761-6762
jbane@fkhealth.com
Page 38 of 41 Total Pages
[NOVARTIS LOGO] 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 2002 international Galien Prize for innovative cancer therapy,
Glivec(R)
After obtaining the national Galien Prize 2002 in six countries, Glivec has now
received a supreme award on an international level
Basel, 3 June 2002 - For the first time, Novartis has been awarded the
prestigious international Galien Prize for therapeutic innovation. It was
awarded to the innovative drug, Glivec(R) (imatinib)*, a molecularly-targeted
treatment for certain forms of chronic myeloid leukemia (CML) in cancer
patients. 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. In the past two years, Novartis research was
honoured nine** times with Galien Prizes for therapeutic innovation.
According to Dr. Daniel Vasella, Chairman and CEO of Novartis AG, "This
prestigious award is a testament to the success of our research and development
efforts and the tremendous medical and scientific potential of Glivec. We are
pleased that eminent professors from all the partner countries of the Galien
Prize have recognised once again this drug which has opened new horizons in
oncology."
This award follows on the heels of additional encouraging research results
presented at the 2002 meeting of the American Society of Clinical Oncology in
Orlando, Florida, USA and the approval of the European Commission for the
treatment of patients with Kit (CD 117) positive unresectable (inoperable)
and/or metastatic malignant gastrointestinal stromal tumors (GISTs).
The international Galien Prize is awarded every two years. The award recognises
innovative therapeutic drugs that have made a substantial improvement in
therapy. Drugs that have already won a prize on a national level compete for the
international prize. This year, Glivec was awarded with the national Galien
Prize in Belgium, Canada, France, Luxembourg, Netherlands and Portugal. The
deliberation meeting for the international Galien Prize was held in Madrid,
under the aegis of the press group MediMedia Spain. The international jury
brought together 13 renowned scientists who represented the national juries. The
prize will be awarded in Madrid on 17 October 2002.
Since 1970, Novartis has received 12 national Prix Galien in six countries for
the innovative therapies Rimactan(R), Parlodel(R), Sandimmune(R),
Sandostatin(R), Simulect(R), Visudyne(R) and recently Glivec(R). Further,
research into Glivec has garnered additional prizes including the Bruce F. Cain
Award from the American Association for Cancer Research (AACR) on April 9 2002
and the
Page 39 of 41 Total Pages
Warren Alpert Foundation Scientific Prize, awarded by Harvard Medical School on
May 2 2002. Both prizes were awarded for the discovery and the preclinical work
on Glivec.
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
Philadelphia chromosome, the abnormality that characterises 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 gastrointestinal stromal tumors (GISTs). For patients with
metastatic or unresectable (inoperable) disease, GISTs represent an incurable
malignancy with a median survival of approximately one year. Until now, surgery
has been the only effective treatment option for most GISTs, resulting
essentially in palliation of the disease.
Glivec was approved in the EU on 7 November 2001 for its initial treatment of
Philadelphia chromosome-positive 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
worldwide. The recent approval in GIST marks the second approval for Glivec
within seven months in the EU.
Contraindications and adverse events
The majority of CML-patients treated with Glivec experience adverse events at
some time. Most events were of mild to moderate grade and treatment was
discontinued for adverse events only in 2% of patients in chronic phase, 3% in
accelerated phase and 5% in blast crisis. 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.
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 72, 600 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Additional information can be found at www.novartisoncologyvpo.com and at
www.novartisoncology.com
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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: July 2, 2002 By: /s/ MALCOLM B. CHEETHAM
---------------------------
Name: Malcolm B. Cheetham
Title: Head Group Financial
Reporting and Accounting
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