Novartis highlights pharmaceutical research strategy, intensifying focus on molecular pathways shared by various diseases

5/3/2005, 7:30 AM (Source: GlobeNewswire)
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* Transforming the "grammar" of drug discovery by focusing on
molecular pathways and patient stratification
* Redefining Research-to-Development transition through fast and
rigorous "proof-of-concept" trials
* More than 60 new molecular entities have potential to enter
trials by end of 2008
* Development pipeline progressing well, key data planned for
second half of 2005

Cambridge, Massachusetts, May 3, 2005 - At an investor conference to
highlight progress at the Novartis Institutes for BioMedical Research
(NIBR), senior Novartis scientists presented their new research
strategy focused on molecular pathways that may be shared by various
diseases as an organizing concept in the search for novel compounds
that address unmet needs of patients.

NIBR is the global pharmaceutical research organization of Novartis
that was created in May 2002 to enhance the company's long tradition
of drug discovery research that has produced breakthrough therapies
such as Gleevec®/Glivec® for cancer patients, Sandimmun®/Neoral® for
use in transplantation and helping those with schizophrenia with
Clozaril®. More than 2,800 research scientists are now working
worldwide within various NIBR institutes, including at the global
headquarters in Cambridge, Massachusetts, to redefine drug discovery
in the genomic era.

A key aspect of the NIBR strategy is to target key cellular pathways
that may be part of the underlying mechanism causing various
diseases. Traditional pharmaceutical development has relied heavily
on identifying appropriate drug "targets," such as single genes or
proteins. However, following the decoding of the genome, drug
discovery is moving quickly toward focusing on interacting pathways
of proteins, which may be at the root of several diseases and
inventing compounds that target critical nodes within the signaling
pathways to alter the disease-causing mechanism.

Dr. Mark Fishman, President of NIBR and a member of the Executive
Committee of Novartis, and his leadership team have instituted
several new fundamental discovery platforms, ranging from those
focused on specific gene families to those intended to integrate key
molecular pathways that cause disease and identify "drugable nodes."
These platforms are already delivering targets under consideration
for transition to full-scale clinical development.

"Unmet patient needs and scientific tractability, driven by an
understanding of the mechanistic underpinning of a disease are the
driving factors for project selection and resourcing in our research
endeavors. The focus on disease pathways provides an organizational
framework for studying diseases creating the foundation to discover
exciting novel medicines," said Dr. Daniel Vasella, Chairman and CEO
of Novartis.

"Proof-of-concept" trials to rigorously test compounds early
As part of the drug discovery transformation, compounds developed at
NIBR enter full-scale clinical development only after successfully
completing "proof-of-concept" trials.

These trials, which are typically done with a small group of
patients, are designed to rapidly assess a compound's efficacy in
humans to provide a foundation for early decisions to advance or
terminate projects. This approach stands in contrast to traditional,
sequential Phase I and early Phase II studies, which are primarily
used to assess safety in healthy volunteers and determine dosage for
pivotal Phase III studies.

"All of our drug discovery efforts begin and end with the patient. By
focusing early on the experience of patients alongside a commitment
to understanding the mechanism of action of a particular disease, our
science is geared toward improving both the patient's medical
condition as well as their quality of life," said Dr. Mark Fishman.
"We are harnessing the power of the genome to invent a 'new grammar'
of drug discovery that will translate breakthroughs in biology and
chemistry into innovative medicines for patients."

For example, Novartis scientists recently completed a successful
proof-of-concept trial of a novel antibody, ACZ885, for inflammatory
conditions. This trial examined patients with a rare inherited
inflammatory condition called Muckle-Wells syndrome, which is
manifested by rash, joint aches, fevers and migraine headaches. All
of these symptoms were relieved within days by a single injection of
the antibody, which was directed to an inflammatory signal known as
IL-1 beta. The positive findings in Muckle-Wells patients may be
indicative of efficacy in other related illnesses, such as rheumatoid
arthritis.

In another positive proof-of-concept clinical trial, the success of
LBM642, a dual agonist of PPAR alpha and gamma, in a dyslipidemia
study suggests that the molecule has the potential for efficacy in
metabolic syndrome, a disease cluster including diabetes, high
cholesterol, and obesity. The results show this compound may overcome
many of the disadvantages of other PPAR alpha/gamma dual agonists, in
particular weight gain and edema.

In Oncology, Novartis is best known for introducing Gleevec/Glivec,
which targets the Bcr-Abl kinase in certain forms of chronic myeloid
leukemia (CML) and gastrointestinal stromal tumors (GIST). Another
novel oral compound is AMN107, which has now entered a Phase II
clinical trial for patients with Philadelphia chromosome-positive
(Ph+) chronic myeloid leukemia (CML) who are resistant or intolerant
of Gleevec as well as patients with relapsed or refractory Ph+ acute
lymphoblastic leukemia (ALL), system mastocytosis or
hypereosinophilic syndrome / chronic eosinophilic leukemia. The
decision to proceed to Phase II was based on Phase I clinical data
that showed more than 90% of patients with chronic phase Ph+ CML
achieved a hematologic response, and more than 60% of patients in the
advanced stages of Ph+ CML achieved similar responses.

Novartis has expanded its oncology research activities to include
other mechanisms of action, particularly inhibition of cell
proliferation/survival pathways and activation of apoptosis (cell
death) pathways. One approach being studied is exposing cancer cells
to a first-in-class SMAC mimetic, which is a small molecule that
blocks the anti-apoptotic protein IAP, to induce cell death. Multiple
cancer models have shown that this compound has reduced the size of
tumors in animals.

Valued and open partner to the research community
NIBR is developing a research strategy based on excellent cooperation
with the company's Development team as well as external partners. In
2004, NIBR established approximately 150 collaborations, including 50
with major biotechnology companies, to complement internal research
activities. Novartis recognizes the value of scientific advances made
by partners and seeks to source the best technologies and early-stage
compounds.

Novartis recognizes the importance of open exchange of information.
For example, NIBR and the Broad Institute of MIT and Harvard will
collaborate on a joint project to decipher the genetic causes of
diabetes. This initiative establishes a research partnership of
physicians, geneticists, computational scientists, pharmaceutical
researchers and others to identify inherited risk factors for
developing the disease and its complications. All findings will be
made available to the public for free on the Internet.

NIBR is also complemented by the company's Corporate Research
activities, which aim to leverage the specific scientific knowledge
from the three institutes - the Novartis Institute for Tropical
Disease (NITD) in Singapore, the Genomics Institute (GNF) in La
Jolla, California; and the Friedrich Miescher Institute (FMI) in
Basel. Corporate Research contributes basic biomedical knowledge in
neuroscience, growth control and epigenetics through the FMI, new
therapeutic targets and technologies through the GNF, and will
contribute drugs for neglected diseases through drug discovery
research at NITD.

Strong pipeline set for dynamic progress
NIBR has a group of 63 new molecular entities currently in advanced
pre-clinical development, of which 16 are antibodies and support the
ability to deliver therapies against a broader set of novel molecular
targets. These compounds are spread across eight key therapeutic
areas, including a particular focus on oncology and
cardiovascular/metabolism.

Novartis is consistently ranked as having one of the strongest
pipelines in the industry, with 75 projects in clinical development
and 55 of them in Phase II, III or registration. Some of these
projects have been highlighted by industry experts for being truly
innovative drugs, including SPP100 (hypertension), LAF237 (diabetes),
FTY720 (multiple sclerosis) and QAB149 (asthma and COPD).

"All of our late-stage projects are progressing well in an
increasingly challenging industry environment marked by an
intensified focus on drug safety," said Dr. Joerg Reinhardt, Head of
Development, Novartis Pharma AG. "This year will be one with strong
newsflow with Phase III data and regulatory submissions expected for
key products. We expect to see dynamic progress in our pipeline."

Recent developments include the submission of Exjade® (deferasirox),
a once-daily oral iron chelator, for US and EU approval. Formerly
known as ICL670, Exjade offers the potential to revolutionize the
treatment of iron overload, providing a once-daily oral formulation
to replace a cumbersome infusion therapy for the treatment of this
potentially life-threatening condition associated with blood
transfusions.

A number of additional submissions are planned for 2005, including
the Phase III compound LDT600 for the treatment of hepatitis B as
well as new indications for Gleevec/Glivec® for
Philadelphia-chromosome-positive(Ph+) acute lymphoblastic leukemia
and the breast cancer agent Femara® for use in the early adjuvant
(post-surgery) setting. Phase III data for LAF237 (vildagliptin) as a
monotherapy and in combination with other anti-diabetic agents is
expected at the end of 2005.

This release contains certain forward-looking statements relating to
the Group's business, which can be identified by the use of
forward-looking terminology such as "potential", "pipeline",
"search", "strategy", "may be", "intended to", "designed to", "geared
toward", "suggests", "will", "aim", "expect", "potential", "planned",
or similar expressions, or by express or implied discussions
regarding potential new products or potential future sales of such
new products, or by other discussions of strategy, plans or
intentions. Such statements reflect the current views of the Group
with respect to future events and are subject to certain risks,
uncertainties and assumptions. There can be no guarantee that any new
products will be approved for sale in any market, or that any
products will reach any particular sales levels. In particular,
management's expectations could be affected by, among other things,
unexpected research results; new clinical data; unexpected clinical
trial results; unexpected regulatory actions or delays or government
regulation generally; the Group's ability to obtain or maintain
patent or other proprietary intellectual property protection;
competition in general; government, industry, and general public
pricing pressures and other risks and factors referred to in the
Group's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those described herein as
anticipated, believed, estimated or expected. Novartis 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
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2004, the Group's businesses achieved sales of
USD 28.2 billion and pro forma net income of USD 5.6 billion. The
Group invested approximately USD 4.2 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 81,400
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com.

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Please find full press release in English attached.

A German version is available through the following link:
German press release


Contacts

John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 61 324 2200 (main)
john.gilardi@novartis.com


Nehl Horton
Novartis Global Media Relations
+41 61 324 5749 (direct)
+41 61 324 2200 (main)
nehl.horton@novartis.com
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