(By Balaseshan) Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) said it will receive additional potential royalty stream related to European Union approval for acute gouty arthritis treating drug.
Regeneron said the European Commission (EC) has approved Novartis AG's (NYSE: NVS) llaris (canakinumab) 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 European Union (EU) for symptomatic pain relief in a gouty arthritis indication, and is administered in a single, subcutaneous injection of 150 mg, Regeneron noted.
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In the EU, 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.
Under a June 2009 agreement with Novartis, Regeneron receives royalties on worldwide sales of Ilaris. The overall royalty rate in the agreement starts at 4% and reaches 15% when annual sales exceed $1.5 billion. In 2012, Regeneron reported full year Ilaris royalties of $2.8 million.
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Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis but this trial has been discontinued. It is also in phase 1 clinical trials as a possible treatment for chronic obstructive pulmonary disease.
In June 2009, the U.S. FDA approved canakinumab for the treatment of cryopyrin-associated periodic syndromes (CAPS) and in October 2009 the European Medicines Agency approved the drug.
REGN is trading up 0.63% at $172.82 on Monday. The stock has been trading between $102.82 and $188.95 for the past 52 weeks.