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Novartis AG (NVS)'s Ilaris Cleared for Gouty Arthritis in EU


3/1/2013 7:33:14 AM

Basel, March 1, 2013 - Novartis announced today that the European Commission (EC) has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered in a single, subcutaneous injection of 150 mg[1].

Ilaris is specifically indicated for the 'symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate'[1].

The EC also granted an additional year of data exclusivity to Novartis based on the significant clinical benefit over existing treatments demonstrated for Ilaris.

"The approval of Ilaris for acute gouty arthritis attacks in patients without appropriate treatment options provides new hope for those debilitated by this excruciating condition," said David Epstein, Division Head of Novartis Pharmaceuticals. "Ilaris targets interleukin-1 beta, a key player in gouty arthritis inflammation. Our vision is to realize the potential of Ilaris wherever IL-1 beta plays a key role and available treatment options don't give patients the help they need."

Gouty arthritis, commonly referred to as gout, is a serious, chronic and progressive inflammatory disease that generally affects 1 to 4% of adults[2],[7]-[10]. Gouty arthritis attacks occur when the body has a strong inflammatory response to uric acid crystals forming in the affected joint, typically of the toe, foot, ankle, or knee[2],[4]. The disease is associated with a high prevalence of comorbidities, such as hypertension, kidney disease, diabetes, dyslipidemia and cardiovascular disease. These conditions can lead to contraindications for existing therapies and complications for disease management[5],[6],[11],[12].

Data from two Phase III trials and their extensions, which supported the EU approval for Ilaris in acute gouty arthritis attacks, showed that patients treated with Ilaris experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide (TA)[13]. The majority of adverse events (AEs) were mild to moderate, with infections (e.g. upper respiratory tract infections and nasopharyngitis) being the most frequent of them.

About Ilaris Phase III Studies

Ilaris has been assessed for the treatment of acute gouty arthritis attacks in two multicentre, randomized, double-blind, active-controlled studies in patients with frequent gouty arthritis attacks (>=3 in the previous year) who were unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy). The studies were 12 weeks in duration followed by 12 week double-blind initial extensions[13].

A total of 454 patients were randomized to receive a single dose of Ilaris 150 mg via subcutaneous injection or TA 40 mg via intramuscular injection[13].

Both trials used an internationally recognized pain scale (visual analogue scale, or VAS) to measure differences in pain 72 hours after treatment. Pain intensity in the overall study population was statistically significantly lower for Ilaris 150 mg compared to TA at 72 hours (-10.7 mm, p<0.0001), with an absolute mean decrease in VAS score of approximately -50 mm. Reduction in pain was observed as early as 6 hours after dosing in both groups. A statistically significant difference between treatments was observed from 24 hours to 7 days. Ilaris also reduced the risk of subsequent attacks[13].

Safety results showed an increased incidence of AEs for Ilaris compared to TA, with 66% vs. 53% of patients reporting any adverse event and 20% vs. 10% of patients reporting an infection adverse event over 24 weeks[1].

A sub-analysis of these studies included 101 patients unable to use NSAIDs and colchicine, and on stable urate lowering therapy (ULT) or unable to use ULT. Pain relief was similar to that shown in the total study population (-10.2 mm for Ilaris 150 mg compared with TA at 72 hours, p=0.0208)[14].

About Ilaris

Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, which is an important part of the body's immune system defenses[1]. Excessive production of IL-1 beta plays a prominent role in certain inflammatory diseases. Ilaris works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation.

In addition to its approval in refractory gouty arthritis in the EU, Ilaris is approved in more than 60 countries, including in the EU, US, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). CAPS is a suite of rare, life-long, genetic, autoinflammatory diseases with debilitating symptoms[1]. The approved indication may vary depending upon the individual country.

Ilaris is being investigated in a number of rare inflammatory conditions, which include, systemic juvenile idiopathic arthritis (SJIA), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), colchicine-resistant Familial Mediterranean Fever (FMF) and cardiovascular disease. Not all patients with these diseases would be eligible for treatment with Ilaris, if approved for the applicable disease.

In the US, Novartis continues to work with the Food and Drug Administration (FDA) to determine the next steps for ACZ885 in gouty arthritis, following a Complete Response letter received in August 2011 with a request by the Agency for additional clinical data to evaluate the benefit risk profile in refractory patients.

About Gouty Arthritis

Gouty arthritis is the most common form of inflammatory arthritis in adults[10],[15]. This chronic and progressive disease is characterized by recurrent attacks in select joints[2]. The intense inflammatory response associated with these attacks may cause severe pain and debilitating symptoms that can last a week or more[2]-[4].

Treatments currently available to manage the pain and inflammation of gouty arthritis attacks, such as NSAIDs, colchicine or corticosteroids, may be inadequate or inappropriate in patients who have certain coexisting medical problems[1],[6],[16]. As a result, there is a significant unmet medical need among individuals with gouty arthritis.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "is being investigated," "vision," "hope," "potential," "would be," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Ilaris or regarding potential future revenues from Ilaris. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Ilaris to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Ilaris will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Ilaris will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Ilaris could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG'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 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 provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

[1] Ilaris [prescribing information]. Surrey, UK: Novartis Pharmaceuticals UK Ltd; 2013.

[2] Schumacher HR, Jr. The pathogenesis of gout. Cleve Clin J Med 2008; 75 Suppl 5:S2-4.

[3] So A, De Meulemeester M, Pikhlak A, et al. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum 2010; 62(10):3064-76.

[4] Mandell BF. Clinical manifestations of hyperuricemia and gout. Cleve Clin J Med 2008; 75 Suppl 5:S5-8.

[5] Harrold LR, Yood RA, Mikuls TR, et al. Sex differences in gout epidemiology: evaluation and treatment. Ann Rheum Dis 2006; 65(10):1368-72.

[6] Riedel AA, Nelson M, Wallace K, Joseph-Ridge N, Cleary M, Fam AG. Prevalence of Comorbid Conditions and Prescription Medication Use Among Patients With Gout and Hyperuricemia in a Managed Care Setting. J Clin Rheumatol 2004; 10(6):308-14.

[7] Badley E, DesMeules M. Arthritis in Canada: an ongoing challenge. Ottawa: Public Health Agency of Canada. 2003.

[8] Begg S, Vos T, Barker B, Stevenson C, Stanley L, Lopez AD, 2007. The burden of disease and injury in Australia 2003. PHE 82. Canberra: AIHW.

[9] Annemans l, Spaepen E, Gaskin M, et al. Gout in the UK and Germany: prevalence, comorbidities and management in general practice 2000-2005. Ann Rheum Dis. 2008; 67(7):960-6.

[10] Zhu Y, Pandya B, Choi H. Increasing gout prevalence in the US over the last two decades: The National Health and Nutrition Examination Survey (NHANES). Presented at: The American College of Rheumatology Annual Scientific Meeting, Oct, 2010, Atlanta, GA, USA.

[11] Choi HK, Ford ES, Li C, Curhan G. Prevalence of the metabolic syndrome in patients with gout: the Third National Health and Nutrition Examination Survey. Arthritis Rheum 2007; 57(1):109-15.

[12] Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther 2010; 12(2):R63.

[13] Schlesinger N, Alten RE, Bardin T, et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised, multicentre, active-controlled, double-blind trials and their initial extensions. Ann Rheum Dis 2012; 71(11):1839-48.

[14] Bardin T, So A, Alten R, et al. Efficacy and safety of canakinumab vs triamcinolone acetonide in patients with gouty arthritis unable to use nonsteroidal anti-inflammatory drugs and colchicine, and on stable urate lowering therapy (ULT) or unable to use ULT. Abstract at: ACR/ARHP Annual Meeting; November, 2012, Washington, D.C., USA.

[15] Silman AJ, Pearson JE. Epidemiology and genetics of rheumatoid arthritis. Arthritis Res. 2002;4 Suppl 3:S265-72.

[16] Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of gout. Rheumatology (Oxford) 2007; 46(8):1372-4.

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