Health Canada expands use of new COX-2 inhibitor
July 25, 2007
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.
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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.
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