Savient Pharmaceuticals Initiates Patient Dosing for Puricase(R) Phase 3 Clinical Study; Company on Track for BLA Filing in Late 2007
Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) a specialty pharmaceutical company engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs, announced today that it has dosed the first patient in its Phase 3 clinical studies of Puricase(R), (PEG-uricase) for the treatment of patients with symptomatic gout for whom conventional therapy is contraindicated or has been ineffective.
The two, replicate Phase 3 clinical studies, Gout Outcomes and Uric acid Treatment or “GOUT 1″ and “GOUT 2″, are designed to compare the safety and efficacy of Puricase(R) administered by two-hour intravenous infusion every two weeks or every four weeks versus placebo infusion, over a six-month period. Each study will randomize approximately 100 patients.
Christopher Clement, Chairman and Chief Executive Officer of Savient Pharmaceuticals, Inc. said, “The start of patient dosing represents an important step in moving Puricase(R) towards commercialization. As we have stated previously, our focus and resources are being devoted towards the development of this promising drug for the treatment of severe gout.”
“The two GOUT studies now underway at approximately 60 clinical sites in the US, Mexico, and Canada incorporate an innovative design and novel methodologies to demonstrate both uric acid control and attainment of clinical outcomes. The first patient was randomized into the Phase 3 program last month as planned, but because of a required run-in/wash-out period between screening and start of dosing, no patient received the first study drug dose in May. Achievement of first patient dosing now, within about one month of FDA’s approval of our Special Protocol Assessment is an important milestone for validating the operational effectiveness of our Phase 3 development team,” said Zeb Horowitz, M.D., Chief Medical Officer and Senior Vice President. “Our CRO partner, Kendle International, which has been working very closely with the Savient team, has a successful track record in the clinical investigation of other biological drugs, particularly those administered by intravenous infusion for rheumatologic diseases. As such, they are ideal collaborators in the clinical development of Puricase (PEG-uricase). “
ABOUT GOUT
According to the National Institutes of Health, gout accounts for approximately 5 percent of all cases of arthritis and is one of the most painful rheumatic diseases. There an estimated 5 million Americans with gout, including perhaps 25,000-100,000 patients for whom conventional therapy is contraindicated or has been ineffective. Gout results from deposits of needle-like crystals of uric acid in connective tissue and in the joints. These deposits lead to inflammatory arthritis, which causes joint swelling, redness, heat, pain, and stiffness and damage to the affected joints. In patients for whom conventional therapy is contraindicated or has been ineffective, the disease can become chronic, progressively worsen and cause debilitating flares of pain and swelling, development of tophi, loss of 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 for individuals with symptomatic gout who cannot be treated adequately by conventional therapies. Puricase(R), (PEG-uricase) has successfully completed Phase 1 and 2 studies, proving to be safe and well-tolerated with few adverse events. Savient licensed exclusive, worldwide rights to the technologies related to Puricase(R) (PEG-uricase) from Duke University (“Duke”) of North Carolina and Mountain View Pharmaceuticals, Inc. (“MVP”), a California corporation. Duke developed the recombinant porcine urate oxidase and MVP developed the PEGylation technology. MVP and Duke were granted U.S. and foreign patents covering the licensed technology. Puricase(R) is a registered trademark 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 engaged in developing, manufacturing and marketing pharmaceutical products that 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 reported positive Phase 1 and 2 clinical data. 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 initial focus in rheumatology. Savient markets its product Oxandrin(R) (oxandrolone, USP) in the United States. The Company’s subsidiary, Rosemont Pharmaceuticals Ltd., develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market. Rosemont’s product portfolio includes over 100 liquid formulations primarily targeting the geriatric population. Puricase(R) is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on the Company can be accessed by visiting: www.savientpharma.com .
FORWARD LOOKING LANGUAGE
This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included in this report regarding the Company’s strategy, expected future financial position, results of operations, cash flows, financing plans, discovery and development of products, strategic alliances, competitive position, plans and objectives of management are forward-looking statements. Words such as “anticipate,”"believe,”"estimate,”"expect,”"intend,”"plan,”"will” and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, the statements regarding the clinical development of Puricase(R) (PEG-uricase), the progress of the Phase 3 clinical trials for Puricase(R) (PEG-uricase), and timing for the filing of an NDA for Puricase(R) (PEG-uricase) are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company’s business and the biopharmaceutical and specialty pharmaceutical industries in which the Company operates. Such risks and uncertainties include, but are not limited to, the Company’s ability to find a buyer for Rosemont Pharmaceuticals and to negotiate and consummate a sale of Rosemont at an attractive price; delay or failure in developing Puricase(R) and other product candidates; difficulties of expanding the Company’s product portfolio through in-licensing; introduction of generic competition for Oxandrin; fluctuations in buying patterns of wholesalers; potential future returns of Oxandrin or other products; the Company’s continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative technologies or more effective products by competitors; reliance on third-parties to manufacture, market and distribute many of the Company’s products; economic, political and other risks associated with foreign operations; risks of maintaining protection for the Company’s intellectual property; risks of an adverse determination in on-going or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company’s forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. The Company’s forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that the Company may make. The Company does not assume any obligation to update any forward-looking statements.
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