We are a specialty biopharmaceutical company focused on developing pegloticase (KRYSTEXXA™) for the treatment of chronic gout in patients refractory to conventional therapy.

Chronic gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.  Pegloticase is not meant for the treatment of asymptomatic hyperuricemia.

In our two replicate randomized, double-blind, placebo-controlled Phase 3 clinical trials, pegloticase, a biologic PEGylated uricase enzyme, demonstrated the normalization of uric acid in patients with chronic gout refractory to conventional therapy. There is no drug or biologic approved for this patient population. 

We believe that if approved, pegloticase will offer physicians and patients a new treatment option for those patients with contraindication to or who have failed to achieve therapeutic success at the maximum medically appropriate dose of xanthine oxidase inhibitors or allopurinol. It is for these patients with refractory chronic gout that pegloticase potentially offers a benefit and for which the compound has been granted orphan drug designation in the United States.

 

 

Savient has licensed worldwide rights to the technology related to pegloticase from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. Oxandrin is a registered trademark of Savient Pharmaceuticals, Inc.  KRYSTEXXA is a trademark of Savient Pharmaceuticals, Inc.