Four Abstracts Accepted for Savient’s Puricase(R) at European League Against Rheumatism 2006 Annual Congress
Savient Pharmaceuticals, Inc., (NASDAQ: SVNT) an emerging specialty pharmaceuticals company focused on developing, manufacturing and marketing novel therapeutic products for unmet medical needs, announced today that four abstracts further detailing data on the Phase 2 clinical trial results of its drug development candidate, Puricase(R) (PEG-uricase), and reporting results of a 12-month non-interventional (observational) study in the Orphan gout population will be presented at the European League Against Rheumatism (EULAR) 2006 Annual Congress in Amsterdam, Netherlands being held June 21-24, 2006.
Abstract titles selected for poster presentations at EULAR 2006 include:
— “A Multicenter Longitudinal Study of Disease Characteristics in Patients with Treatment-failure Gout”
— “Quality of Life in Patients with Treatment-failure Gout”
— “A Phase 2 Study of Multiple Doses of Intravenous Polyethylene Glycol (PEG)-uricase in Patients with Hyperuricemia and Treatment-failure Gout”
— “Resolution of Tophi with Intravenous PEG-uricase in Treatment-failure Gout”
To view chosen abstracts, please visit the congress website at: www.eular.org/eular2006.
Zeb Horowitz, MD, Senior Vice President and Chief Medical Officer observed, “Two of our EULAR Abstracts present data from a 12-month observational study in treatment-failure (Orphan) gout patients. This data had a direct impact on Phase 2 and Phase 3 Puricase trial designs and highlight quantitatively the serious medical consequences of gout leading to a significant adverse impact on patients’ quality of life. The second set of EULAR abstracts expands on the data first reported at the American College of Rheumatology Annual Meeting in November 2005, and contains new data on the occurrence of antibodies.”
“In Phase 2, Puricase achieved a rapid and continuous control of plasma uric acid, and also showed beneficial clinical outcomes unexpected for such a short treatment period, 3 months, for example reduction in frequency of gout flares and elimination of gout tophi. The presence or absence of antibodies did not appear to correlate with efficacy or safety endpoints. We are strongly encouraged by the favorable Phase 2 efficacy and safety results and look forward to moving ahead with our Phase 3 program in the near future,” said Dr. Horowitz.
Christopher Clement, President and Chief Executive Officer of Savient commented, “Since the announcement of our positive Phase 2 results, Puricase has garnered significant scientific and medical attention. We believe the ability of Puricase to normalize plasma uric acid levels within hours and eradicate gout tophi with 3 months of treatment is indeed unprecedented. We are extremely pleased at the acceptance of these abstracts on Puricase at this prestigious scientific meeting for the European rheumatology community and look forward to advancing Puricase into Phase 3 and towards commercialization.”
Savient licensed exclusive, worldwide rights to the technologies related to Puricase (PEG-uricase) from Duke University (“Duke”) of North Carolina and Mountain View Pharmaceuticals, Inc. (“MVP”), a California corporation. Duke developed the recombinant porcine uricase enzyme and MVP developed the PEGylation technology. MVP and Duke were granted U.S. and foreign patents covering the licensed technology. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
ABOUT SAVIENT
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 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 (PEG-uricase), commencement of the Phase 3 clinical trial for Puricase (PEG-uricase), time for completion of patient recruitment and timing for the filing of an NDA for Puricase (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 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.