Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) a specialtypharmaceutical company engaged in developing, manufacturing, andmarketing pharmaceutical products that address unmet medical needs,announced today that it has dosed the first patient in its Phase 3clinical studies of Puricase(R), (PEG-uricase) for the treatment ofpatients with symptomatic gout for whom conventional therapy iscontraindicated or has been ineffective.The two, replicate Phase 3 clinical studies, Gout Outcomes andUric acid Treatment or “GOUT 1″ and “GOUT 2″, are designed to comparethe safety and efficacy of Puricase(R) administered by two-hourintravenous infusion every two weeks or every four weeks versusplacebo infusion, over a six-month period. Each study will randomizeapproximately 100 patients.
Christopher Clement, Chairman and Chief Executive Officer ofSavient Pharmaceuticals, Inc. said, “The start of patient dosingrepresents an important step in moving Puricase(R) towardscommercialization. As we have stated previously, our focus andresources are being devoted towards the development of this promisingdrug for the treatment of severe gout.”
“The two GOUT studies now underway at approximately 60 clinicalsites in the US, Mexico, and Canada incorporate an innovative designand novel methodologies to demonstrate both uric acid control andattainment of clinical outcomes. The first patient was randomized intothe Phase 3 program last month as planned, but because of a requiredrun-in/wash-out period between screening and start of dosing, nopatient received the first study drug dose in May. Achievement offirst patient dosing now, within about one month of FDA’s approval ofour Special Protocol Assessment is an important milestone forvalidating the operational effectiveness of our Phase 3 developmentteam,” said Zeb Horowitz, M.D., Chief Medical Officer and Senior VicePresident. “Our CRO partner, Kendle International, which has beenworking very closely with the Savient team, has a successful trackrecord in the clinical investigation of other biological drugs,particularly those administered by intravenous infusion forrheumatologic diseases. As such, they are ideal collaborators in theclinical development of Puricase (PEG-uricase). ”
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According to the National Institutes of Health, gout accounts forapproximately 5 percent of all cases of arthritis and is one of themost painful rheumatic diseases. There an estimated 5 millionAmericans with gout, including perhaps 25,000-100,000 patients forwhom conventional therapy is contraindicated or has been ineffective.Gout results from deposits of needle-like crystals of uric acid inconnective tissue and in the joints. These deposits lead toinflammatory arthritis, which causes joint swelling, redness, heat,pain, and stiffness and damage to the affected joints. In patients forwhom conventional therapy is contraindicated or has been ineffective,the disease can become chronic, progressively worsen and causedebilitating flares of pain and swelling, development of tophi, lossof joint functionality, renal disease and kidney stones.
ABOUT PURICASE(R), (PEG-URICASE)
Puricase(R) is a chemically modified form of recombinant uricase,based on mammalian sequences, under development by Savient forindividuals with symptomatic gout who cannot be treated adequately byconventional therapies. Puricase(R), (PEG-uricase) has successfullycompleted Phase 1 and 2 studies, proving to be safe and well-toleratedwith few adverse events. Savient licensed exclusive, worldwide rightsto the technologies related to Puricase(R) (PEG-uricase) from DukeUniversity (“Duke”) of North Carolina and Mountain ViewPharmaceuticals, Inc. (“MVP”), a California corporation. Dukedeveloped the recombinant porcine urate oxidase and MVP developed thePEGylation technology. MVP and Duke were granted U.S. and foreignpatents covering the licensed technology. Puricase(R) is a registeredtrademark of Mountain View Pharmaceuticals, Inc.
ABOUT SAVIENT PHARMACEUTICALS
Based in East Brunswick, New Jersey, Savient Pharmaceuticals,Inc., is an emerging specialty pharmaceuticals company and is engagedin developing, manufacturing and marketing pharmaceutical productsthat address unmet medical needs in both niche and broader markets.The Company’s lead product development candidate, Puricase(R)(PEG-uricase), for the treatment of refractory gout has reportedpositive Phase 1 and 2 clinical data. Savient’s experienced managementteam is committed to advancing its pipeline and expanding its productportfolio by in-licensing late stage compounds and exploringco-promotion and co-development opportunities that fit the Company’sexpertise in specialty pharmaceuticals and initial focus inrheumatology. Savient markets its product Oxandrin(R) (oxandrolone,USP) in the United States. The Company’s subsidiary, RosemontPharmaceuticals Ltd., develops, manufactures, and markets through itsown sales force oral liquid formulations of prescription products forthe UK pharmaceutical market. Rosemont’s product portfolio includesover 100 liquid formulations primarily targeting the geriatricpopulation. Puricase(R) is a registered trademark of Mountain ViewPharmaceuticals, Inc. Further information on the Company can beaccessed by visiting: www.savientpharma.com .