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 dated July 25, 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. Zometa(R) receives EU approval for the prevention of cancer-related bone
complications
2. FDA approves Zelnorm(TM), a novel treatment for irritable bowel syndrome
in women with constipation
Page 1 of 7 Total Pages
Novartis 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 -
Zometa(R) receives EU approval for the prevention of cancer-related bone
complications
Zometa is the first and only bisphosphonate demonstrating efficacy across a
broad range of solid tumors
Basel, 24 July 2002 - Novartis today announced that the European Agency for the
Evaluation of Medicinal Products (EMEA) has granted marketing authorization in
the European Union (EU) for Zometa(R) (zoledronic acid) for the prevention of
skeletal related events in patients with advanced malignancies involving bone.
These malignancies include multiple myeloma, prostate cancer, breast cancer,
lung cancer, renal cancer and other solid tumors. This is the broadest range of
tumor types in which a bisphosphonate has ever demonstrated efficacy. Zometa
offers patients and clinicians a highly effective treatment with a convenient
15-minute infusion time.
"We are pleased to see that medical and regulatory authorities around the world
are recognizing the value of Zometa in treating the debilitating bone
complications associated with advanced cancer," said David Epstein, President,
Novartis Oncology.
Advanced malignancies in a broad range of solid tumors, including breast, lung,
prostate, bladder and renal cancers often spread (metastasize) to bones, while
multiple myeloma is a type of cancer that originates in the bones. Zometa is an
intravenous bisphosphonate newly indicated to prevent these complications - or
skeletal related events (SREs) - which represent a significant problem for
cancer patients in the advanced stages of the disease. They include pathological
fractures, spinal compression, radiation or surgery to bone, or tumor-induced
hypercalcaemia.
In February, the US Food and Drug Administration granted approval for the use of
Zometa in treating patients with multiple myeloma and patients with documented
bone metastases from solid tumors, in conjunction with standard antineoplastic
therapy. Additionally, recent clinical practice guidelines from The American
Society of Clinical Oncology support the use of Zometa in the treatment of bone
lesions in multiple myeloma. The guidelines will be published in the September
issue of the Journal of Clinical Oncology and are currently available online
(JCO July 1, 2002).
Clinical Data
The approval for Zometa is based on data from three large international clinical
trials evaluating more than 3000 patients with myeloma, prostate cancer, breast
cancer, lung cancer and other solid tumor types studied in the clinical trials.
This is the largest set of clinical trials ever conducted to
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evaluate the efficacy and tolerability of a bisphosphonate in preventing
skeletal complications in patients with bone metastases.
Zometa has been shown in clinical trials to decrease the skeletal complications
of patients with multiple myeloma and with bone metastases from solid tumors.
Results have also demonstrated that Zometa delays the initial onset of bone
complications by more than two months in patients with non-small cell lung
cancer and other solid tumors. In two placebo-controlled clinical studies
conducted in patients with bone metastases from prostate cancer or other solid
tumors, there was a decrease in the number of patients with skeletal related
events, whereas the time to first skeletal related event was delayed.
About Zometa
To date, Novartis has received marketing authorisation for Zometa in the
multiple myeloma and bone metastases indication in more than 35 countries,
including the EU. Previously, Novartis received marketing clearance for Zometa
in the treatment of hypercalcaemia of malignancy, also known as tumor-induced
hypercalcaemia, in more than 70 countries throughout the world.
Contraindications and Adverse Events
In clinical trials in patients with bone metastases, Zometa had a safety profile
similar to other bisphosphonates. The most commonly reported adverse events
included flu-like syndrome (fever, arthralgias, myalgias, bone pain), fatigue,
gastrointestinal reactions, anaemia, weakness, cough, dyspnoea and oedema.
Zometa is contraindicated during pregnancy, in breast-feeding women and in
patients with clinically significant hypersensitivity to zoledronic acid or
other bisphosphonates, or any of the excipients in the formulation of Zometa.
Zometa and other bisphosphonates have been associated with reports of renal
insufficiency. Patients should have serum creatinine assessed prior to receiving
each dose of Zometa; single doses of Zometa should not exceed 4 mg and the
duration of infusion should be no less than 15 minutes. Caution is advised when
Zometa is administered with other potentially nephrotoxic drugs.
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 74,000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 3 of 7 Total Pages
Novartis 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 -
FDA approves Zelnorm(TM), a novel treatment for irritable bowel syndrome in
women with constipation
Zelnorm(TM) is first and only prescription therapy in the US for the relief of
the common symptoms of abdominal pain and discomfort, bloating, and constipation
in women with IBS
Basel, 24 July 2002 - The Novartis drug Zelnorm(TM) (tegaserod maleate)* today
became the first and only prescription medication approved by the US Food and
Drug Administration (FDA) for the short-term treatment of women with irritable
bowel syndrome (IBS) whose primary bowel symptom is constipation. Until now, no
prescription medication has been approved in the United States to treat the
multiple symptoms of abdominal pain and discomfort, bloating, and constipation
associated with IBS. The medical community has recognized that therapies
traditionally used to treat these symptoms have been generally ineffective or
poorly tolerated.
"Zelnorm marks a breakthrough for the millions of women who have suffered for
years with IBS with constipation waiting for a safe and effective therapy to
relieve their symptoms," said Daniel Vasella, MD, Chairman and CEO, Novartis AG.
"As with our discoveries in oncology, heart disease and transplantation, Zelnorm
reflects our commitment to bring innovative treatments to patients with
significant unmet needs. We will rapidly make Zelnorm available to patients, and
plan for an early fall market introduction. "
About IBS
IBS is characterized by abdominal pain and discomfort, bloating, and altered
bowel function (constipation and/or diarrhea). IBS affects up to one in five
Americans. Second only to the common cold as a leading cause of workplace
absenteeism in the US, IBS costs the US healthcare system up to an estimated $30
billion annually in direct and indirect costs.
"Patients suffering from abdominal pain and discomfort, bloating, and
constipation associated with IBS endure a great deal of distress, often
preventing them from participating in such simple everyday activities as going
to work or school, participating in sports, or enjoying a vacation with their
family," said Nancy Norton, President and Founder of the International
Foundation for
----------------
* In the US, Canada, and South Africa: Zelnorm(TM)(tegaserod maleate), all other
countries: Zelmac(R)(tegaserod)
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Functional Gastrointestinal Disorders. "The approval of Zelnorm is very
exciting news for millions of women who suffer from this condition."
Until recently, the cause of IBS has been poorly understood and under
appreciated. However, in recent years, new research has yielded a better
understanding of IBS and its causes. People who have abdominal pain and
discomfort, bloating and constipation associated with IBS have a lower GI tract
that may be more sensitive and work more slowly than it should. This may be due
to the way their lower GI tract reacts to changes in a naturally occurring
chemical in their body that regulates mobility in the intestinal system, and the
perception of pain and discomfort.
About Zelnorm
Zelnorm is the first agent in a new class of drugs called serotonin-4 receptor
agonist (5HT4 agonist) developed to target the GI tract. By activating 5HT4
receptors, Zelnorm stimulates the peristaltic reflex and normalizes impaired
mobility in the GI tract. Zelnorm is the first agent proven to provide relief of
the abdominal pain and discomfort, bloating and constipation caused by IBS.
"IBS with constipation is a very real medical disorder that has frustrated
patients and physicians due to the obvious lack of any safe and effective
prescription medications to treat the painful symptoms," said Pete Peterson, MD,
University of Texas, Southwestern School of Medicine in Dallas. "Zelnorm is an
important advancement in IBS therapy. We can now provide safe and effective
symptom relief to a significant number of patients for whom this was not
possible before."
The FDA approval of Zelnorm is based on clinical trials that show Zelnorm
provides relief of the abdominal pain and discomfort, bloating and constipation
in women with IBS. Three multicenter, double blind, placebo-controlled studies
involved 2,470 women with at least a three-month history of IBS symptoms prior
to the study baseline period. Patients received either Zelnorm 6 mg/b.i.d. or a
placebo over a three-month period.
Each week, participants rated their responses to the "Subject's Global
Assessment of Relief," a measurement tool which takes into account overall well
being, symptoms of abdominal pain and discomfort, and constipation. Based on
this assessment, more patients on Zelnorm experienced relief than patients on
placebo. In addition, Zelnorm was shown to provide relief of the individual
symptoms of abdominal pain and discomfort, bloating, and constipation.
In clinical studies, Zelnorm was generally well tolerated. The side effects that
occurred more often with Zelnorm than with placebo were headache (15% vs. 12%)
and diarrhea (9% vs. 4%). The majority of the Zelnorm patients reporting
diarrhea had a single episode. In most cases, diarrhea occurred within the first
week of treatment. Typically, diarrhea resolved with continued therapy. Zelnorm
is not indicated for patients who are currently experiencing or frequently
experience diarrhea. The safety and effectiveness of Zelnorm in men have not
been established.
Zelnorm was discovered and developed by Novartis. Zelnorm, known internationally
as Zelmac, is approved in more than 30 countries including Australia,
Switzerland, Canada and Brazil. Novartis also is conducting clinical assessments
of Zelnorm as a potential treatment for other important gastrointestinal
disorders such as chronic constipation and functional dyspepsia. It is the tenth
Novartis product to receive FDA approval since January 2000.
The foregoing press release contains forward-looking statements that can be
identified by terminology such as "will rapidly make Zelnorm available", "plan
for an early fall market
Page 5 of 7 Total Pages
introduction", "also is conducting", "potential treatment", or similar
expressions, or by statements regarding the potential sales of Zelnorm in the
US, or by discussions of potential additional indications for Zelnorm. 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 of the commercial success of Zelnorm in the
US or elsewhere, or that the aforementioned clinical assessments will result in
the commercialization of any additional indications for Zelnorm in any market.
Any such commercial success or commercialization of additional indications, or
other results, performance or achievements expressed or implied in such
statements, 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, uncertainties relating to
pharmaceutical production, 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 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
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 74 000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
# # #
Page 6 of 7 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: July 25,2002 By: /s/ MALCOLM B. CHEETHAM
--------------------------------
Name: Malcolm B. Cheetham
Title: Head Group Financial
Reporting and Accounting
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