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 January 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: Releases regarding:
1. FDA Advisory Committee recommends approval of Novartis drug Zometa(R)for
the treatment of cancer-related bone complications (January 31, 2002);
2. Study shows Exelon(R)(rivastigmine) beneficial for patients with
subcortical vascular dementia (January 28, 2002);
3. International consensus meeting confirms Levodopa as the most effective
treatment for Parkinson's disease (January 24, 2002);
4. Novel irritable bowel syndrome (IBS) therapy Zelmac(R)approved in
Australia (January 22, 2002);
5. New publication underscores efficacy and safety of Lescol(R)/lescol(R)XL
(January 17, 2002);
6. Novartis Animal Health enters US farm-animal vaccine market through two
acquisitions (January 17, 2002);
7. Early positive Glivec(R) data in newly diagnosed chronic myeloid
leukemia (CML) study prompt major protocol changes (January 7, 2002).
Page 1 of 16 Total Pages
Investor Relations Novartis International AG
NOVARTIS LOGO CH-4002 Basel
Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zentner
Tel +41 61 324 8612
Francisco Bouzas
Tel +41 61 324 8444
Fax + 41 61 324 8844
Internet Address:
http://www.novartis.com
- Investor Relations Release -
FDA Advisory Committee recommends approval of Novartis drug Zometa(R) for the
treatment of cancer-related bone complications
Basel, 31 January 2002 - Novartis announced today that the Oncologic Drugs
Advisory Committee (ODAC) of the US Food and Drug Administration (FDA)
recommended approval of Zometa(R) (zoledronic acid) for the treatment of bone
complications (metastases) associated with a broad range of tumor types. These
include prostate cancer, lung cancer, and other tumor types for which no
intravenous bisphosphonate therapy is currently approved for treatment, as well
as breast cancer and the osteolytic lesions associated with multiple myeloma.
Zometa offers patients and clinicians a highly effective treatment with a
convenient 15-minute infusion time.
"Novartis is pleased that ODAC has recognized the favorable results of Zometa in
the treatment of bone metastases in a broad range of tumor types and has
recommended its approval," said David Parkinson, MD, Vice President, Clinical
Research at Novartis Oncology. "Based on extensive experience, we believe that
Zometa offers significant benefit for helping cancer patients manage this
painful and debilitating aspect of their disease."
The FDA generally follows the recommendations of its Advisory Committees
although it is not obliged to do so. Novartis submitted the new drug application
(NDA) for the use of Zometa in these indications to the US FDA on 22 August 2001
and, on 23 October 2001 the NDA received a priority review designation.
Submission to the EMEA in the European Union was made on 30 July 2001.
Clinical Data
The NDA for Zometa is based on data from three large international clinical
trials evaluating more than 3,000 patients with myeloma, breast cancer, prostate
cancer, lung cancer and other solid tumors. This is the largest set of clinical
trials ever conducted to evaluate the efficacy and tolerability of a
bisphosphonate in treating cancerous bone lesions.
About Zometa
ZOMETA is a new generation intravenous (IV) bisphosphonate. Novartis has
previously received marketing clearance for Zometa in the treatment of
hypercalcaemia of malignancy (HCM), also known as tumor-induced hypercalcaemia
(TIH), in the European Union and more than 60 countries, including the United
States, Switzerland, Brazil, Canada and Australia.
Contraindications and Adverse Events
In clinical trials in patients with bone metastases, Zometa was generally well
tolerated with a safety profile similar to other bisphosphonates. The most
commonly reported adverse events included flu-like syndrome (fever, arthralgias,
myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness,
cough,
Page 2 of 16 Total Pages
dyspnoea and edema. Occasionally, patients experienced electrolyte and
mineral disturbances, such as low serum phosphate, calcium, magnesium and
potassium.
Bisphosphonates, including Zometa, have been associated with reports of renal
function deterioration. Patients who receive Zometa should have periodic
evaluations of standard laboratory and clinical parameters of renal function.
Doses of Zometa should not exceed 4 mg and the duration of infusion should be no
less than 15 minutes. Zometa should only be used during pregnancy if the
potential benefit justifies the risk to the fetus. Zometa is contraindicated in
patients with clinically significant hypersensitivity to zoledronic acid or
other bisphosphonates, or any of the excipients in the formulation of Zometa.
This release contains certain forward-looking statements relating to the
Company's business, which can be identified by the use of forward-looking
terminology such as "recommended approval," "highly effective," "we believe,"
"potential," "favorable results," and "offers significant benefit," or similar
expressions, or by discussions of strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause actual results with Zometa to be materially
different from any future results, performance or achievements expressed or
implied by such statements. Some of these are uncertainties relating to
unexpected regulatory delays, further clinical trial results regarding efficacy
or safety of Zometa, government regulation or competition in general, as well as
factors discussed in the Company's Form 20F filed with the Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70,000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com
# # #
Page 3 of 16 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
Study shows Exelon(R)(rivastigmine) beneficial for patients with subcortical
vascular dementia
Supports possible future application for Exelon use beyond current indication
for Alzheimer's disease
Basel, 28 January 2002 - Exelon(R) (rivastigmine) improves various aspects of
mental functioning and behavior in individuals with subcortical vascular
dementia, according to a study1 presented today at the Second International
Congress on Vascular Dementia in Salzburg, Austria. Exelon is currently approved
for treatment of mild to moderate Alzheimer's disease, and is under
investigation for the treatment of vascular dementia.
"This is the first study to evaluate the safety and efficacy of Exelon in
patients with subcortical vascular dementia, a condition for which there are
currently few therapeutic options," said Rita Moretti, MD, lead author of the
study and a Neurologist at Cattinara Hospital at the University of Trieste in
Italy. "These initial findings are very promising because they showed that
Exelon provided broad, significant and sustained improvements in these patients,
and also reduced stress levels among the patients' caregivers," she said.
Subcortical vascular dementia is one of the major types of vascular dementia
which is due to poor blood circulation in the subcortical area of the brain. It
refers to a decline in mental functioning that interferes with the ability to
perform routine activities. Vascular dementia is the second most common cause of
dementia, accounting for about 20 percent of all cases by itself and up to
another 20 percent in combination with Alzheimer's disease. Alzheimer's disease
is the leading cause of dementia, accounting for about 50 percent of all cases.
Vascular dementia usually affects people between the ages of 60 and 75 and is
slightly more common in men than in women.2
In the study, ten men and six women diagnosed with subcortical vascular dementia
were randomly assigned to be treated with either Exelon (3 mg/day, increased to
6 mg/day over 4 weeks) or cardioaspirin for 22 months (results after 12 months
have previously been reported3). At the beginning and end of the study, patients
were given a variety of standard tests to assess various aspects of cognitive
function, the ability to perform daily living activities, behavioral symptoms
(e.g., mood, delusions and hallucinations), caregiver stress level, and side
effects.
By the end of the study, the Exelon group showed significant improvement in
"executive function," a type of cognitive function related to the ability to
plan and organize, and in behavioral symptoms, compared to baseline (p < 0.01
and p < 0.05, respectively) and compared to the control group (p < 0.001 and p <
0.01, respectively). The improvements in the Exelon patients were reflected in
the lower stress levels among their caregivers by the end of the study (p < 0.05
vs. baseline, p < 0.01 vs. caregivers of control patients). On average, all the
other measures were maintained at baseline levels among patients given Exelon.
By contrast, control patients showed no improvements on any of the tests, and
showed significant deterioration over baseline in executive function and
Clinical Dementia Rating (both p < 0.05).
Page 4 of 16 Total Pages
"Deterioration in executive function and behavior are cardinal features of
subcortical vascular dementia," said Dr. Moretti. "Therefore, assessing them was
particularly relevant in this study, and the improvements we observed suggest
Exelon is beneficial in treating the disease," she said.
Side effects in both groups were well tolerated, with transitory nausea the most
frequently reported in both groups. No patient withdrew from either group before
the end of the study and no serious adverse events were reported. No specific or
organic cardiac problems were reported. Although patients were allowed to
continue any previous medication, no side effects that might be related to drug
interactions were reported.
Although its exact causes are not understood, Alzheimer's disease and vascular
dementia are associated with a decline in the ability to transmit signals
between nerves in the brain, especially those that rely on the neurotransmitter
acetylcholine. Exelon is unique because it works in treating Alzheimer's disease
by inhibiting the two key enzymes involved in breaking down acetylcholine -
acetylcholinesterase and butyrylcholinesterase - thus preventing the breakdown
of the neurotransmitter and prolonging its action. Other drugs used to treat
Alzheimer's disease, such as donepezil and galantamine, inhibit
acetylcholinesterase but not butyrylcholinesterase. Recent research suggests
that butyrylcholinesterase may play an increasingly important role in regulating
acetylcholine levels as Alzheimer's disease progresses, and that the dual
inhibitory action of Exelon may provide greater and more sustained efficacy in
treating patients with the disorder.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 "possible future application", "improves", "is under
investigation", "very promising", "significant improvement" "improvements,
"suggests", "may provide", or similar expressions. Such forward looking
statements involve known and unknown risks, uncertainties and other factors that
may cause actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements. There are
no guarantees that the aforementioned clinical trials will result in the
commercialisation of any product in any market. Any such commercialisation can
be affected by, amongst other things, uncertainties relating to product
development, regulatory actions or delays or government regulation generally,
the ability to obtain or maintain patent or other proprietary intellectual
property protection and competition in general, as well as factors discussed in
the Company's Form 20F filed with the Securities and Exchange Commission. Should
one or more of these risks or uncertainties 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
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70 000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
# # #
1 Moretti R, Torre P, Antonello RM, Cazzato G. Rivastigmine is safe and
effective for at least 22 months in patients with subcortical vascular dementia.
Abstract number 37. Presented at: The Second International Congress on Vascular
Dementia, Salzburg, Austria, January 25, 2002.
2 The "Dementia" Directory. Vascular dementia.
Available at http://www.zarcrom.com/users/alzheimers/odem/d4.html
3 Moretti R, Torre P, Antonello RM, Cazzato G. Rivastigmine. In subcortical
vascular dementia: a comparison trial on efficacy and tolerability for 12 months
follow up. Eur J Neurol 2001;8:361-2.
4 Ballard CG. Advances in the treatment of Alzheimer's disease: benefits of
dual cholinesterase inhibition. Eur Neurol 2002;47:64-70.
Page 5 of 16 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
International consensus meeting confirms Levodopa as the most effective
treatment for Parkinson's disease
Meeting also concludes that use of COMT inhibitors may enhance levodopa benefits
Basel, 24 January 2002 - The world's leading experts in Parkinson's disease (PD)
agree that levodopa therapy is deservedly unchallenged as the most effective
treatment for the distressing symptoms of PD. Introduced in the 1960s, levodopa
represents the cornerstone of PD therapy, and all patients receive this
medication at some point during the course of their disease.
Speaking from the international levodopa consensus meeting held on 17th-18th
January 2002 in Zurs, Austria, Professor Yves Agid, a leading neurologist and
head of neurology at the Hospital de la Salpetriere, Paris, France said "We have
been impressed by the evidence presented at this international consensus
meeting, which confirms once again that levodopa is still the most effective PD
therapy available today. Furthermore, the increasing evidence that the problems
previously associated with levodopa therapy can now be resolved, will allow
physicians to prescribe levodopa with confidence and ensure that it continues to
be the mainstay of treatment for many years to come."
A panel of 28 internationally renowned neurologists and neuroscientists met in
Austria to discuss the role of levodopa in clinical practice where all experts
unanimously agreed that levodopa fully deserves it's place as the gold standard
of therapy for the treatment of PD. In the past, levodopa therapy has been
compromised by a series of complications that include involuntary movements and
motor complications. Evidence was presented that the mechanism responsible for
these complications relate not so much to levodopa itself, but rather to the way
in which it is administered. Recent studies strongly indicate that new ways of
delivering levodopa, including the use of a COMT inhibitor, reduces the risk of
developing motor complications in animal studies, and this may be the same in
humans.
Scientists also discussed the potential of levodopa to be toxic and concluded
that, while levodopa can be toxic in some in vitro models, an increasing number
of studies suggest it may confer neuroprotection.
Commenting on the main conclusions from this meeting, Professor Fabrizio
Stocchi, Director of the Parkinson's Disease Research, Vincenza, Italy said "In
the past 4 years, since the last consensus meeting, we have significantly
advanced in our understanding of the mechanisms underlying the effects of
levodopa. There is now clinical evidence that a more continuous, phsiological
delivery of levodopa can reverse motor complications. It appears that one of the
ways to achieve this is by using a combination of levodopa with a COMT
inhibitor."
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 enhance", "unchallenged", "will allow", "continues",
"gold standard", "indicate", reduces the risk", "may be", "it appears", suggest"
or
Page 6 of 16 Total Pages
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. Such statements reflect the current
views of the meeting with respect to future events and are subject to certain
risks, uncertainties and assumptions. Many factors could cause the actual
results, performance or achievements to be materially different from any future
results, performances or achievements that may be expressed or implied by such
forward-looking statements. Some of these are uncertainties relating to clinical
trials and product development, unexpected regulatory delays or government
regulation generally, and obtaining and protecting intellectual property, as
well as factors discussed in the Group'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, 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
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70 000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
Orion Pharma is a research and development-orientated pharmaceutical division of
the Orion Group. The Orion Group (HEX:ORI) is one of the leading companies in
the healthcare sector in the Nordic area of Europe. The 2000 net sales of the
Group were EUR 948 million. The Orion Group employs around 5,300 people.
Pharmaceutical R&D at Orion Pharma produce new innovative drugs in four core
therapy areas: CNS therapies, cardiology and critical care, hormonal therapies,
and respiratory therapies. Entacapone, a COMT enzyme inhibitor, is Orion
Pharma's patented molecule discovery, which Orion Pharma developed through
multinational clinical trials. Entacapone is available globally as Comtess and
Comtan. For further information please consult http://www.orionpharma.com.
# # #
Page 7 of 16 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
Novel irritable bowel syndrome (IBS) therapy Zelmac(R)approved in Australia
Basel, 22 January 2002 - Novartis announced today that the Australian
Therapeutics Goods Administration has granted marketing authorization for
Zelmac(R) (tegaserod), the first medication clinically proven to provide
symptomatic relief for women with abdominal pain/discomfort and constipation
associated with irritable bowel syndrome (IBS).
"The approval of Zelmac in Australia is very encouraging and will provide timely
access to a much needed therapy for patients suffering from the chronic,
debilitating symptoms of IBS" said Nicholas J. Talley, Professor of Medicine,
University of Sydney. "I am optimistic that this product will significantly
improve the daily quality of life of thousands of Australian women."
The prevalence of IBS in Australia ranges from 10-20%,1 with two thirds of
sufferers being female. Zelmac is the first single effective therapy available
in Australia to treat the multiple symptoms of IBS, which include abdominal
pain/discomfort, and constipation.
"The approval of Zelmac in Australia is yet another milestone in our ongoing
commitment to launch this product globally," said Thomas Ebeling, CEO, Novartis
Pharma AG. "We believe this approval will serve as additional positive evidence
of the safety and efficacy profile of Zelmac to health authorities in other
countries, as we continue to negotiate with their regulatory bodies."
About Zelmac
Zelmac is approved in Switzerland and in several Latin American countries
including Mexico, Argentina, Venezuela and Columbia. Novartis continues to work
with the U.S. Food and Drug Administration (FDA) and the European Agency for the
Evaluation of Medicinal Products (EMEA) to help bring the benefits of this
important new therapy to patients in need.
Clinical Data
The approval of Zelmac in Australia is based on clinical trials involving more
than 4,500 patients. Throughout the trials two-thirds of patients treated with
Zelmac experienced overall symptom relief, including improvements in abdominal
pain/discomfort, bloating and constipation.2 The majority had relief within one
week.3 The drug was well tolerated with an adverse event profile similar to that
of placebo, with the exception of headache and diarrhea, which in most cases was
mild and transient.4,5 Discontinuations based on adverse events were 6.4 % for
the Zelmac treated group compared with 4.6 % for the placebo group in the final
trial.2
The foregoing press release contains certain forward-looking statements related
to the business of Novartis, which can be identified by the use of
forward-looking terminology such as "encouraging", "will provide", "will soon be
launched", "continues", "ongoing", or similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that
may cause actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements.
Management's expectation regarding the commercial potential of tegaserod in any
market could be affected by, amongst other things, uncertainties relating to
product development, regulatory actions or
Page 8 of 16 Total Pages
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
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70 000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
# # #
References:
1. Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M. Treatment of
irritable bowel syndrome with Chinese herbal medicine: a randomized
controlled trial. JAMA 1998;280:1585-1590.
2. Mueller-Lissner S, et al. Tegaserod, a 5-HT4 partial agonist, relieves
symptoms in irritable bowel syndrome patients with abdominal pain,
bloating and constipation. Aliment Pharmacol Ther 2001;16:1655-66.
3. Integrated summary of efficacy. January 2000. Novartis, data on file.
4. Lefkowitz M, et al. Tegaserod provides relief of symptoms in female
patients with irritable bowel syndrome (IBS) suffering from abdominal
pain and discomfort, bloating and constipation. (Abstr).
Gastroenterology 2001;120:A104.
5. Integrated summary of safety. December 2000. Novartis data on file.
Page 9 of 16 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 publication underscores efficacy and safety of Lescol(R)/Lescol(R)XL
Basel, 17 January 2002 - Lescol(R)/Lescol(R) XL (fluvastatin), the
cholesterol-lowering drug from Novartis, offers a particularly favourable
efficacy/safety profile according to a large-scale analysis of CPK (creatine
phosphokinase) safety data published in this month's American Journal of
Cardiology(1). Based on an analysis of all the Lescol studies conducted by
Novartis from 1987 to 2001 and involving nearly 9000 patients, the report
confirms that Lescol/Lescol XL as monotherapy is highly effective in lowering
blood lipids, and has a CPK safety profile similar to that of placebo (inactive
treatment).
"This is a key finding", said co-author Dr Jonathon Isaacsohn, Cincinnati, Ohio.
"Statins have proved generally well tolerated and have a favourable safety
profile, but there may be significant differences between them. Our analysis of
CPK elevations in these clinical trials shows that Lescol/Lescol XL has a very
favourable safety profile, similar to that of placebo. No cases of
rhabdomyolysis were observed."
Importantly, a previous pooled analysis of three phase-3 studies demonstrated
that Lescol/Lescol XL was effective in managing lipid levels, achieving
reductions of up to 38% in harmful LDL-cholesterol, and up to 31% in
triglycerides, while raising levels of beneficial HDL-cholesterol by up to 21%2.
This underscores the drug's favourable efficacy/safety profile in patients who
need comprehensive lipid management.
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 "effective", "achieving", or similar expressions. Such
forward looking statements involve known and unknown risks, uncertainties and
other factors that may cause actual results to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There are no guarantees that the aforementioned clinical trials will
result in the commercialisation of any product in any market. Any such
commercialisation can be affected by, amongst other things, uncertainties
relating to product development, regulatory actions or delays or government
regulation generally, the ability to obtain or maintain patent or other
proprietary intellectual property protection and competition in general, as well
as factors discussed in the Company's Form 20F filed with the Securities and
Exchange Commission. Should one or more of these risks or uncertainties
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
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70 000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com
* * *
1 Benghozi et al. Am J Cardiol 2002;89:231-3.
Page 10 of 16 Total Pages
2 Ballantyne et al: Efficacy and Tolerability of Fluvastatin Extended-Relases
Delivery System: A Pooled Analysis. Clinical Therapeutics 2001, No 2, Vol 23,
p177-192
Page 11 of 16 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 Animal Health enters US farm-animal vaccine market through two
acquisitions
Basel, 17 January 2002 - Novartis Animal Health today announced that it has
acquired Grand Laboratories Inc. and ImmTech Biologics Inc., two US companies
specialized in the development, manufacture and marketing of vaccine products
for cattle and pigs. The acquisitions provide Novartis with immediate entry into
the world's largest farm animal vaccine market, the US. The two businesses
generated combined revenues of USD 33 million in 2001. Financial details were
not disclosed.
"These acquisitions are strategically linked by strong synergies," said
Hans-Beat Gurtler, CEO of Novartis' Animal Health Sector. "Grand Laboratories'
well-established manufacturing, registration and marketing capabilities ideally
support and enhance ImmTech's state-of-the-art research. The two companies have
an exciting development portfolio in important disease areas that are not fully
covered by vaccines today," Mr Gurtler added.
Novartis Animal Health has been strategically expanding into the attractive and
growing animal vaccine market since 1999, when it bought the British company
Vericore. The following year it acquired the Canadian vaccine businesses of
Biostar and Cobequid.
Located in Larchwood, Iowa, Grand Laboratories Inc. is one of the largest animal
vaccine companies in the US. As a fully integrated business with research,
development, manufacturing and marketing capabilities, it offers a broad range
of conventional cattle and pig vaccines and has a promising end-stage pipeline
to fuel future growth.
ImmTech Biologics Inc. is a small and innovative animal vaccine company situated
in Bucyrus, Kansas, and focused on the development of novel products for cattle
and pig rearing. The company holds several proprietary technologies and also has
a number of new product introductions pending.
The acquisitions include the production sites and research facilities of both
companies, as well as all brands of cattle and pig vaccines for respiratory and
enteric diseases. Novartis Animal Health intends to maintain the combined
current staff of approximately 230.
The foregoing information contains forward-looking statements that can be
identified by terminology such as "promising", "intend" or similar expressions.
Such forward-looking 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 expectations regarding future
research and development results, or the performance of the acquired companies,
could be affected by, among other things, unexpected regulatory delays or
government regulation generally; uncertainties relating product development; the
introduction of competitive products; changes in the market for animal-based
products; changes in the company's ability to obtain or maintain patent and
other proprietary intellectual property protection and competition in general.
Page 12 of 16 Total Pages
Some of these factors are discussed in the Form 20-F filed by Novartis with the
Securities and Exchange Commission. Should one or more of theses risk or
uncertainties matereialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated,
believed, estimated or expected.
Novartis Animal Health researches, develops and commercializes leading animal
treatments that meet the needs of pet owners, farmers and veterinarians.
Headquartered in Basel, Switzerland and present in 40 countries, Novartis Animal
Health employs approximately 2000 associates worldwide and achieved sales of CHF
1.08 billion in 2000. For more information, please consult www.ah.novartis.com.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70 000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
# # #
Page 13 of 16 Total Pages
Investor Relations Novartis International AG
NOVARTIS LOGO CH-4002 Basel
Switzerland
Karen J Huebscher, PH.D.
Tel +41 61 324 8433
Nafida Bendali
Tel +41 61 324 3514
Sabine Moravi, MBA
Tel + 41 61 324 8989
Silke Zentner
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 -
Early positive Glivec(R) data in newly diagnosed chronic myeloid leukemia (CML)
study prompt major protocol changes
Basel, 7 January 2002 - In an interim analysis of the ongoing Phase III study
comparing Glivec(R) (imatinib)1 to standard therapy (interferon injections plus
Ara-C chemotherapy) for initial treatment in newly-diagnosed CML patients, the
Glivec arm was found - early on - to demonstrate a substantially higher
response. Based on this finding, the Independent Data Monitoring Board (IDMB)
has recommended a change in the protocol to enable the patients on standard
therapy who have not achieved a major cytogenetic response to switch to Glivec
at this time.
The changes to the study protocol as recommended by the IDMB (comprised of
independent hematologists and a clinical statistician) are being communicated to
investigators and patients beginning 3 January. These changes allow patients on
the control arm who have not achieved a major cytogenetic response after one
year of treatment with interferon-alpha and cytarabine to switch to Glivec. A
cytogenetic response is the disappearance or reduction in the number of
cancerous cells. Patient consent forms will be changed to inform patients of the
new data, and to urge them to speak with their physicians.
Called the IRIS study (International Randomized study of Interferon vs. STI571),
this large, international multicentre Phase III trial is evaluating Glivec vs.
the combination of standard interferon and cytarabine as first line therapy in
patients with chronic myeloid leukemia. Between June 2000 and January 2001, the
ongoing study enrolled 1106 patients in 177 centres across 16 countries. The
study was designed to help determine the long-term outcome (including survival)
of patients with newly diagnosed CML treated with Glivec in comparison to the
combination of interferon-alpha and cytarabine.
The Independent Data Monitoring Board further recommended that a formal,
peer-reviewed presentation of the 12-month data results be made to the
scientific community at the earliest possible opportunity.
Preliminary results from a different and smaller, single-institution study in
newly diagnosed CML patients were presented in December, 2001 at the annual
meeting of the American Society for Hematology.* The data from this trial on the
use of Glivec in 47 newly diagnosed patients with early chronic phase CML showed
that after three months of treatment, 77% (36 patients) had achieved complete or
major cytogenetic responses [(Ph<35%) Philadelphia chromosome, hallmark of the
disease]. The hematologic response rate was 98% (46 patients). In comparison, in
previously reported studies of other agents (interferon-alpha alone
--------
1 Outside the US: Glivec(R)(imatinib); in the US: Gleevec(TM)(imatinib mesylate)
Page 14 of 16 Total Pages
and interferon-alpha with cytarabine (Ara-C) and homoharringtonine [Triple Rx])
2-24% of patients on other treatments achieved complete or major cytogenetic
responses after three months of treatment.
Contraindications and Adverse Events
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 1% of patients in chronic phase, 2% in accelerated
phase and 5% in blast crisis. The most common side effects included nausea,
fluid retention, vomiting, diarrhea, hemorrhage, 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 "early positive results," "to help determine,"
"preliminary results," or similar expressions. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause
actual results with Glivec to be materially different from any future results,
performance or achievements expressed or implied by such statements. In
particular, management's ability to ensure satisfaction of the FDA's further
requirements is not guaranteed and management's expectations regarding further
commercialization of Glivec could be affected by, among other things, additional
analysis of data; new data; unexpected clinical trial results for Glivec in the
IRIS trial or other Glivec clinical trials; unexpected regulatory actions or
delays or government regulation generally; the Company's ability to obtain or
maintain patent or other proprietary intellectual property protection;
competition in general; and other risks and factors referred to in the Company's
current Form 20-F on file with the Securities and Exchange Commission of the
United States. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in
pharmaceuticals, consumer health, generics, eye-care, and animal health. In
2000, the Novartis Group's ongoing businesses achieved collective sales of CHF
29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in
R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group
companies employ about 70,000 people and operate in over 140 countries around
the world. For further information please consult http://www.novartis.com.
* Presented by Hagop Kantarjian, MD, Professor of Medicine, Chairman,
Department of Leukemia and Chief, Section of Leukemia Developmental
Therapeutics, M.D. Anderson Cancer Center, Houston, Texas.
# # #
Page 15 of 16 Total Pages
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Novartis AG
Date: February 5, 2002 By: /s/ RAYMUND BREU
-------------------------
Name: Raymund Breu
Title: Chief Financial Officer
Page 16 of 16 Total Pages