Novartis suspends Canadian marketing and sales of Zelnorm(R) in response to request from Health Canada



    
    - Recent retrospective analysis of pooled clinical trial data shows that
      the incidence of cardiovascular ischemic events in patients taking
      Zelnorm higher than in those taking placebo

    - Novartis believes Zelnorm provides important benefits for appropriate
      patients.

    - Discussions ongoing with Health Canada to evaluate best way to continue
      to make Zelnorm available to appropriate Canadian patients
    

    DORVAL, QC, March 30 /CNW Telbec/ - Novartis is complying with a request
from Health Canada to suspend Canadian marketing and sales of Zelnorm(R)(1)
(tegaserod maleate) as a treatment for irritable bowel syndrome with
constipation (IBS-C) and chronic idiopathic constipation (CIC).
    This action has been taken following a retrospective analysis of data
from more than 18,000 patients in the Zelnorm clinical trial database.
    A small (but non statistically significant) imbalance in cases of angina
pectoris was recorded and included in the Canadian label when Zelnorm was
approved in 2002. However, a recent analysis of the entire Zelnorm clinical
database revealed a statistically significant imbalance in the incidence of
cardiovascular ischemic events in patients taking Zelnorm compared to those
taking placebo. These events included myocardial infarction, stroke, and
unstable angina pectoris.
    The data, which were reviewed by independent experts, showed that events
occurred in 13 out of 11,614 Zelnorm-treated patients (0.11%), compared to one
case out of 7,031 placebo-treated patients (0.01%). All patients affected had
pre-existing cardiovascular disease and/or CV risk factors.
    Results obtained from multiple mechanistic studies do not suggest any
arterial vasoconstrictive effects of tegaserod.
    "My review of the data suggested that a causal relationship is unlikely
between tegaserod and the rare cardiovascular ischemic events observed in
clinical trials," said Jeffrey L. Anderson, MD, Professor of Internal Medicine
at the University of Utah and Associate Chief, Cardiology Division, LDS
Hospital in Salt Lake City and an independent cardiologist who reviewed the
data. "Furthermore, the data did not show any consistent pattern of event
type, time to event or dose relationship in tegaserod-treated patients."
    Nevertheless, Novartis has suspended the marketing and sales of Zelnorm
in response to Health Canada's request in order to further evaluate this
important safety information.
    Novartis and Health Canada will communicate this information to
physicians and patients, and will discuss the best way to continue to make
Zelnorm available to appropriate patients. Canadian patients taking Zelnorm
are being advised to stop taking their medication and consult their physicians
regarding alternative treatment options.

    About Zelnorm

    Zelnorm received Health Canada approval for the treatment of women with
IBS-C in Canada in March 2002. Zelnorm also received Health Canada approval
for the treatment of patients less than 65 years of age with chronic
idiopathic constipation in Canada in October 2005.
    Zelnorm/Zelmac is approved for the treatment of IBS with constipation in
more than 50 countries including Australia, Switzerland, Canada, the US,
Mexico, China and Brazil. Zelnorm is also approved for the treatment of
chronic constipation in more than 20 countries including the US, Canada and
Mexico. Novartis markets the therapy under the trademark Zelnorm (tegaserod
maleate) in the US, Canada, Philippines and South Africa; and as Zelmac
(tegaserod) in Switzerland, Latin America and the Asia-Pacific region.

    Disclaimer

    The foregoing release contains certain forward-looking statements that
can be identified by terminology such as "will," "outlook," or similar
expressions, or by express or implied discussions regarding potential future
approvals to return Zelnorm/Zelmac to the market, or potential future sales of
Zelnorm/Zelmac, or the potential impact of Zelnorm/Zelmac on the potential
future sales or earnings of the Novartis Group or its Pharmaceuticals
Division. Such forward-looking statements involve known and unknown risks,
uncertainties or 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. There can be no guarantee that
Zelnorm/Zelmac will be approved by the FDA or other health authorities for
return to the market for any indication, or that Zelnorm/Zelmac will achieve
any particular level of sales. Nor can there be any guarantees that the
Novartis Group, or the Pharmaceuticals Division, will achieve any particular
financial results. In particular, management's expectations regarding these
matters could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical
trial results or results of data analysis, including additional analysis of
existing clinical data and other data regarding patients' experience with
Zelnorm/Zelmac, or unexpected new clinical or other such data; competition in
general; government, industry and general public pricing pressures; the
ability to obtain or maintain patent or other proprietary intellectual
property protection; as well as factors discussed in the Company's Form 20-F
filed with the US Securities and Exchange Commission. Novartis is providing
the information in this press release as of this date and does not undertake
any obligation to update any forward-looking statements contained in this
press release as a result of new information, future events or otherwise.

    About Novartis Canada

    Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, diabetes, cancer, organ
transplantation, musculoskeletal diseases and ophthalmic diseases. In 2005,
the Company invested over $65 million in research and development. Novartis
Pharmaceuticals Canada Inc. employs approximately 800 people in Canada and its
headquarters are located in Dorval, Quebec. In addition to Novartis
Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis
Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including
Novartis Nutrition Corporation and Gerber (Canada) Inc.) Sandoz Canada and
CIBA Vision Canada Inc. For further information about Novartis Canada, please
visit www.novartis.ca.

    About Novartis

    Novartis AG (NYSE:   NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. We are strengthening our
medicine-based portfolio, which is focused on strategic growth platforms in
innovation-driven pharmaceuticals, high-quality and low-cost generics, human
vaccines and leading self-medication OTC brands. Novartis is the only company
with leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 101,000 associates
and operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.

    --------------
    (1) Also marketed as Zelmac in some countries




For further information:

For further information: Jason Jacobs, Communications, Novartis
Pharmaceuticals Canada, (514) 633-7872, jason.jacobs@novartis.com


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890