One of Novartis's top blockbuster hopefuls registered promising data in two pivotal trials for gout, offering supportive data for a string of regulatory filings in Europe and the U.S.
ACZ885--an antibody also known as Ilaris which blocks the interleukin-1 beta protein--provided significantly improved pain relief and a sharp reduction in the risk of fresh attacks of gout compared to an injectable steroid. Investigators recruited more than 450 patients for the studies who didn't fit the profile for standard therapies.
For Novartis the promising Phase III results mark another significant success for the R&D side of the business. Analysts give the treatment a solid shot at achieving blockbuster status with more than a billion dollars in annual revenue--provided the pharma company can continue to broaden the use of the drug beyond the one percent to four percent of the population which suffers from gouty arthritis with new indications for use. And the late-stage wins provide Novartis's management with fresh evidence to prove that its R&D ops can deliver.
"These findings show that ACZ885 may represent an important advance in the treatment of gouty arthritis in sufferers whose disease cannot be appropriately managed with currently available treatments," says Professor Alexander So, one of the studies' investigators. "Scientists only recently learned that the root cause of the pain in gouty arthritis is interleukin-1 beta. Through specifically targeting interleukin-1 beta, these studies show ACZ885 can effectively treat painful attacks while extending the time to new attacks."