Savient Pharma Says KRYSTEXXA Received European Commission Marketing Authorization

SavientPharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, SavientPharma Ireland Ltd., today announced that the European Commission has granteda marketing authorization for KRYSTEXXA^® (pegloticase) for the treatment ofsevere debilitating chronic tophaceous gout in adult patients who may alsohave erosive joint involvement and who have failed to normalize serum uricacid with xanthine oxidase inhibitors at the maximum medically appropriatedose or for whom these medicines are contraindicated."There is currently no other treatment option in the EU for patients withsevere chronic tophaceous gout who do not respond to oral xanthine oxidaseinhibitors," said Dr. Thomas Bardin, MD, Professor and Head of theRheumatology department at the Lariboisière Hospital in Paris, France. "KRYSTEXXA addresses a significant unmet medical need and represents animportant development for healthcare professionals and European patientssuffering from this debilitating disease."   "European approval of KRYSTEXXA demonstrates our ongoing commitment to thisunderserved population by offering a much needed treatment option to thesepatients and marks a significant milestone for the Company," said Lou Ferrari,President and Chief Executive Officer of Savient. "We continue to establishrelationships with clinicians and key opinion leaders in Europe, and weanticipate product launch in the region by mid-2013."The European Commission's approval decision was based upon safety and efficacydata from Savient's two pivotal Phase III studies, and a long-term open labelextension study of KRYSTEXXA, as well as non-clinical and chemistry,manufacturing and control information.  Until the product becomes commercially available in the EU, Savient willcontinue to provide KRYSTEXXA to patients through the established NamedPatient Programme (NPP).