Voltaren® Gel receives US regulatory approval as the first approved
topical prescription treatment for pain associated with
* First US approval for a prescription NSAID (non-steroidal
anti-inflammatory drug) treatment that can be applied directly to
site of osteoarthritis pain
* Voltaren Gel the only prescription topical medication proven to
significantly reduce osteoarthritis pain in both the knees and
the joints of the hands
* Offers highly effective pain relief with minimal drug absorption
throughout the body - shown to be 94% less than comparable oral
Basel, October 22, 2007 - Voltaren® Gel (diclofenac sodium topical
gel) 1% has received US regulatory approval as the first topical
prescription treatment that patients can apply directly to sites of
pain associated with osteoarthritis.
The US Food and Drug Administration (FDA) granted the approval for
Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID)
medication, for use in treating pain associated with osteoarthritis
in joints amenable to topical treatment, such as the knees and those
of the hands.
Osteoarthritis is a chronic condition characterized by the breakdown
of cartilage in the joint.
Clinical trials have demonstrated Voltaren Gel to be highly effective
in treating osteoarthritis pain in the hands and knees, which are the
body's most commonly affected joints. It is the first topical
osteoarthritis treatment to have proven its effectiveness in both the
hands and knees through clinical trials.
Voltaren Gel, which will be marketed in the US by the OTC business
unit since this is the case in many other countries, delivers
effective pain relief with a favorable safety profile as its systemic
absorption is 94% less than the comparable oral diclofenac treatment.
"Voltaren Gel is proven to be effective for osteoarthritis of the
hand and knee and has a favorable safety profile. The combination of
benefit and safety provides a welcome new treatment approach for
osteoarthritis, offering patients an alternative to oral therapies,"
said Roy Altman, MD, Professor of Medicine in the Division of
Rheumatology and Immunology at UCLA in Los Angeles and Past President
of the Osteoarthritis Research Society International. "Voltaren Gel
delivers the proven efficacy of diclofenac with significantly less
systemic absorption, minimizing the risk of side effects."
The efficacy and safety of Voltaren Gel were studied in more than 900
patients with knee or hand osteoarthritis. The US approval was based
on several studies, including the results of two randomized,
double-blind, placebo-controlled efficacy studies and a 12-month
Voltaren Gel was shown to significantly reduce pain in hand and knee
osteoarthritis, with pain relief sustained through the end of
treatment. After six weeks of treatment in an efficacy study of
patients with osteoarthritis of the hand, results showed that pain
levels were reduced by nearly half (46%). In a 12-week study in
patients with osteoarthritis of the knee, Voltaren Gel showed a 51%
reduction in pain.
"Voltaren Gel represents an important clinical milestone - it is the
first prescription topical treatment in the US shown to relieve
osteoarthritis pain and to clinically prove efficacy in treating both
the knees and hands," said Jorge Insuasty, MD, Senior Vice President,
Research and Development in the Group's OTC business unit. "Patients
now have the option to effectively treat osteoarthritis pain at the
source with favorable tolerability."
Approximately 21 million people in the US have osteoarthritis, and
the aging population in the US means 72 million more will be at risk
for developing the condition by 2030. Osteoarthritis is a chronic,
painful condition that often leads to working limitations and reduced
Osteoarthritis is a chronic condition characterized by the breakdown
of cartilage in the joint. Cartilage cushions the ends of the bones
in joints - such as knees, hands, elbows, wrists, ankles and feet -
which allows for easy movement. When cartilage erodes, bones can rub
together, resulting in pain and loss of free movement in the
joint. The most common symptoms include pain, joint soreness,
stiffness and deterioration of overall coordination, posture and
Arthritis and related conditions, such as osteoarthritis, cost the US
economy nearly USD 128 billion per year in medical care and indirect
expenses, including lost wages and production.
Despite the high prevalence of osteoarthritis, there is no cure for
this disease, which tends to progressively reduce mobility and the
overall health state in the affected patients.
About Voltaren Gel
Voltaren Gel provides 1% diclofenac sodium in a topical gel
formulation. It is a non-steroidal anti-inflammatory (NSAID)
medication indicated for the pain of osteoarthritis in joints
amenable to topical treatment, such as the knees and those of the
hands. Voltaren Gel delivers highly effective pain relief with a
favorable safety profile as its systemic absorption is 94% less than
comparable oral diclofenac treatment.
Important safety information
The most common adverse reactions reported in Voltaren Gel clinical
trials were application site reactions in 7% of treated patients.
With all NSAIDs there may be an increased risk of serious
cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be fatal. NSAIDs cause an increased risk of serious
gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal. The use
of Voltaren Gel is contraindicated in patients with a known
hypersensitivity to diclofenac. Voltaren Gel should not be
administered to patients who have experienced asthma, urticaria or
other allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been
reported in such patients. Voltaren Gel is contraindicated for the
treatment of peri-operative pain in the setting of coronary artery
bypass graft (CABG) surgery.
Voltaren Gel should not be used in combination with other oral NSAIDs
or aspirin because of the potential for increased adverse effects.
Similarly, combined use of Voltaren Gel with other topical products,
such as sunscreens and cosmetics, on the same skin area has not been
tested and should be avoided because of the potential to alter local
tolerability and absorption.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "often leads to," "may be,"
"can be," or similar expressions, or by express or implied
discussions regarding potential future revenues from Voltaren Gel.
Such forward-looking statements reflect the current views of the
Company regarding future events, and 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 can be no
guarantee that Voltaren Gel will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding commercialization of Voltaren Gel could be affected by,
among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of
existing clinical data, competition in general, increased government,
industry and general public pricing pressures, unexpected regulatory
actions or delays or government regulation generally, and other risks
and factors referred to in Novartis AG'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.
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 our website at
 U.S. Centers for Disease Control and Prevention (CDC). Arthritis
Related Statistics. Available at:
Accessed on October 17, 2007.
 National Institute of Arthritis Musculoskeletal and Skin Diseases
(NIAMS), National Institutes of Health, U.S. Department of Health and
Human Services. Handout on Health: Osteoarthritis. Available at:
Accessed on October 17, 2007.
 Arthritis Foundation. Available at: www.arthritis.org. Accessed
on October 17, 2007.
 U.S. Centers for Disease Control and Prevention (CDC). [CDC
(2007) Update: National and State Medical Expenditures and Lost
Earnings Attributable to Arthritis and Other Rheumatic
Conditions-United States, 2003. MMWR Morb Mortal Wkly Rep,
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