Savient Pharmaceuticals is a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical products that target unmet medical needs in rheumatology and other specialty niche medical markets.  Our focus is on our novel biologic product candidate, Puricase® (pegloticase) that has been developed for treatment-failure gout (TFG).

Pegloticase achieved significant positive results in its Phase 3 program on treatment-failure gout patients which was conducted under the auspices of a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA) and was granted orphan drug designation. At the end of 2008, the FDA accepted for review the Company's Biologics License Application (BLA) for pegloticase and granted it with a priority review status which accelerates the review period to six months. A priority review designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. Under priority review, the target date for an FDA decision on the pegloticase BLA is August 1, 2009.

We believe that if approved, pegloticase may offer physicians and patients with a new treatment option for those patients who are contraindicated to or have failed to achieve therapeutic success at the maximum medically appropriate dose of allopurinol, meaning that they have no effective treatment option.  It is for these treatment-failure patients that pegloticase potentially offers a unique benefit and for which the compound has been granted orphan drug designation.

Savient has licensed worldwide rights to the technology related to Puricase from Duke University and Mountain View Pharmaceuticals, Inc.  Savient’s experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late-stage compounds and exploring co-promotion and co-development opportunities that fit the Company’s expertise in specialty pharmaceuticals and biopharmaceuticals with an initial focus in rheumatology.  Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. 

Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.