Health Canada expands use of new COX-2 inhibitor

    Prexige(*) now available to patients suffering from osteoarthritis in
    any joint

    DORVAL, QC, July 25 /CNW/ - Novartis Pharmaceuticals Canada Inc.
announced today the expanded Health Canada approval of Prexige(*) (lumiracoxib)
for the acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA) in adults. Initially approved for OA of the knee in
November 2006, Prexige is a unique selective COX-2 inhibitor that provides
osteoarthritis patients with an effective and safe option for controlling
pain, improving their mobility and quality of life.(1)
    "This new treatment is welcome news for many patients who have had no
choice but to endure the debilitating effects of osteoarthritis with little
relief from their pain," says Dr. Jameel Razack, a family physician in
Toronto. "With Prexige, we now have a much needed option to offer our
osteoarthritis patients that can effectively and safely reduce their joint
pain and improve their mobility."
    After living with osteoarthritis for many years, George Soteroff, a
Toronto business executive, had run out of options to control the pain in his
knees. Then, a few months ago, Mr. Soteroff's doctor prescribed a new
treatment that allowed him to take back control of his disease, and his life.
    "I was at the point where my knee pain was unbearable and the only
treatment left for me wasn't controlling it. I had run out of options and it
was very frustrating for me, and for my doctor," recalls Mr. Soteroff. "My
entire life was affected - mornings were slowed down by pain and stiffness,
getting around during the day wasn't much easier, and playing golf was very
difficult."
    Uncontrolled pain from OA can have a serious impact on a patient's
physical and emotional well-being, which can significantly reduce the overall
quality of life for the three million Canadians battling this disease.(2)
These patients rely on a variety of treatment options to control their pain,
because not all respond to medications in the same way. But, in recent years,
effective and safe options to treat OA pain have become increasingly limited,
leaving more than one in five patients without sufficient pain relief from
their current non-steroidal anti-inflammatory drug (NSAID) therapy.(3)

    Most common form of arthritis

    OA is the most common form of arthritis, impacting the lives of more than
three million Canadians (1 in 10). The disease affects the joints in the body
and usually involves the hands and weight-bearing joints such as hips, knees,
feet and spine. OA can occur at any age but most people develop it after the
age of 45. Symptoms usually come on slowly and include pain and stiffness or
swelling around the joints.(2)
    "Uncontrolled osteoarthritis symptoms can lead to reduced mobility,
muscle deterioration and a further increase in joint pain," said John Fleming,
President and CEO, The Arthritis Society. "It is always a good day when new
treatment options become available for people with osteoarthritis. We urge
governments, as we always do to recognize the needs of people living with the
pain of arthritis to have timely access to all medications approved for use in
Canada."
    In fact, many patients like George Soteroff depend on effective and safe
treatment options like Prexige to lead productive and active lifestyles.
    "Once I started taking Prexige, I noticed immediate and significant
improvements, from first thing in the morning and lasting all day," says Mr.
Soteroff. "My knees are not sore and the joints are much looser. I walk
without a limp now, rather than a stagger, and I recently played nine holes of
golf, pulling a heavy golf cart up and down hills - a first in a couple of
years!" he adds.

    About Prexige

    Prexige works by blocking cyclooxygenase-2 (COX-2), an enzyme that
promotes joint inflammation, while sparing another similar enzyme called COX-1
which helps protect the mucous lining in the stomach, unlike traditional
NSAIDs. Prexige is considered unique because it is rapidly cleared from the
body, it reaches a higher concentration in the joint synovial fluid, and it is
preferentially retained in inflamed tissue, allowing for once per day
dosing.(4)
    Prexige is the first COX-2 selective inhibitor to be approved in Canada
since the withdrawal of two medications in the same class, in 2004-2005.
COX-2s were first marketed in Canada in 1999 as anti-inflammatory medications
that caused less gastrointestinal side-effects (e.g. ulcers) than traditional
NSAIDs, such as ibuprofen.
    Following the COX-2 withdrawals, several expert bodies in arthritis held
a consensus conference, in 2005, and identified a gap in pain relief for the
three million Canadians living with OA. This group, and the arthritis
community, concluded that patients need a variety of medications, including
COX-2 inhibitors, which are effective and safe.
    Initially approved for OA of the knee in November, 2006, Prexige has the
largest body of evidence supporting the launch of an NSAID, traditional and
COX-2, with a clinical trial database of over 34,000 patients. In the
Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), the
largest safety outcomes study published in OA (18,325 patients), Prexige, at
four times the recommended OA dose, was compared to the traditional NSAIDs
ibuprofen and naproxen.(5,6)
    TARGET found that Prexige provided a 79 per cent reduction in the
incidence of upper GI ulcer complications, among non-aspirin users, in
comparison to those treated with traditional NSAIDs naproxen and
ibuprofen.(5,6,7) The treatment also showed no significant difference in risk
of cardiovascular events, such as heart attack or stroke compared to the other
NSAIDs.(6)
    Recent data presented at the 2007 Annual European Congress of
Rheumatology showed that Prexige has significantly less impact on blood
pressure than ibuprofen, a commonly-used NSAID.(8) These new results are
important because approximately 40 per cent of patients with osteoarthritis
also have high blood pressure (or hypertension).(9,10)
    Novartis is committed to ensuring that Prexige is prescribed
appropriately and has launched a comprehensive, long-term study to monitor
20,000 Canadian patients on selected NSAIDs/COX-2 inhibitors, including
Prexige. This first-of-its kind, real-life study will further build on the
strong body of safety evidence available on Prexige. This commitment will be
further supported through strong health education programs for physicians and
pharmacists across the country.

    Forward-looking statement

    The foregoing release contains forward-looking statements that can be
identified by terminology such as "strong," "sustained pain relief,"
"significant" or similar expressions, or by express or implied discussions
regarding potential additional marketing approvals or future sales of Prexige.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors that may cause actual results with Prexige to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Prexige will
receive any additional marketing approvals in any other countries, or that it
will reach any particular sales levels. In particular, management's
expectations regarding commercialization of Prexige could be affected by,
among other things, additional analysis of Prexige clinical data; new clinical
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; increased government, industry, and general public
pricing pressures; and other risks and factors referred to in the Company's
current Form 20-F on file with the U.S. 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 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 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 conducts hundreds of clinical trials across the country seeking new
treatments for cardiovascular disease, diabetes, cancer, organ
transplantation, musculoskeletal diseases and ophthalmic diseases. In 2006,
the Company invested over $69 million in research and development. Novartis
Pharmaceuticals Canada Inc. employs approximately 850 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
consult http://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 100,000 associates
and operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.


    (*) Prexige is a registered trademark.

    References
    ---------------

    (1)   Prexige (product monograph). Dorval, QC: Novartis Pharmaceuticals
          Canada Inc.; 2007.
    (2)   Osteoarthritis. The Arthritis Society. Available at: 
http://www.arthritis.ca/types%20of%20arthritis/osteoarthritis/default.asp?s=1N
o.(5CB4540E-AB9A-11D4-BCC6-00D0B7474671) Accessed May 24, 2007.
    (3)   Tannenbaum H, Bombardier C, David P, Russell A, et al. An Evidence-
          Based Approach to Prescribing Nonsteroidal Antiinflammatory Drugs.
          Third Canadian Consensus Conference. J Rheumatology 2006;
          33:140-57.
    (4)   Rordorf C, et al. Clinical pharmacology of lumiracoxib: a selective
          cyclo-oxygenase-2 inhibitor. Clin Pharmacokinet 2005;
          44(12):1247-1266.
    (5)   Schnitzer T, et al. Comparison of lumiracoxib with naproxen and
          ibuprofen in the Therapeutic Arthritis Research and
          Gastrointestinal Event Trial (TARGET), reduction in ulcer
          complications: a randomized controlled trial. Lancet. 2004;
          364(9435):665-674.
    (6)   Farkouh M, et al. Comparison of lumiracoxib with naproxen and
          ibuprofen in the Therapeutic Arthritis Research and
          Gastrointestinal
          Event Trial (TARGET), cardiovascular outcomes: a randomized
          controlled trial. Lancet. 2004; 364(9435): 675-684.
    (7)   Pavelka K, et al. Lumiracoxib is effective and well tolerated in
          the long-term treatment of knee osteoarthritis. Ann Rheum Dis
          2005;64 (Suppl. 3):353 (Abstract FRI0319).
    (8)   MacDonald, TM et al. Improved blood pressure control but similar
          efficacy with Prexige 100 mg od compared to ibuprofen 600 mg tid in
          hypertensive patients with osteoarthritis: randomised clinical
          trial. Presented at EULAR 2007 (SAT0239).
    (9)   Singh G, Miller JD, Lee FH, et al. Prevalence of cardiovascular
          disease risk factors among US adults with self-reported
          osteoarthritis: data from the Third National Health and Nutrition
          Examination Survey. Am J Manag Care 2002 Oct;8(15 Suppl):S383-91.
    (10)  Maetzel A, Li LC, Pencharz J,et al. The economic burden associated
          with osteoarthritis, rheumatoid arthritis, and hypertension: a
          comparative study. Ann Rheum Dis. 2004 Apr;63(4):395-401.

For further information: Media contacts: For additional information
about this news release or to arrange an interview with a physician, patient
or The Arthritis Society, please contact: Joanne Koskie, Cohn & Wolfe, (416)
924-5700, ext. 4049, joanne_koskie@ca.cohnwolfe.com; Jason Jacobs, Novartis
Pharmaceuticals Canada Inc., (514) 633-7872, jason.jacobs@novartis.com;
Christina Scicluna, Cohn & Wolfe, (416) 924-5700, ext. 4037,
christina_scicluna@ca.cohnwolfe.com