Extreme Pain Of Gout Is Detrimental To Quality Of Life & Work , New Poll Shows

Main Category: Gout
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Nov 2006 - 4:00 PDT

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Results of a new survey show that two-thirds (65 percent) of gout patients ranked their typical gout flares -- defined as a sudden, intense pain -- as either close to, or the worst pain possible and say that the flares last an average of eight days. Seventy-two percent reported having experienced at least one flare within the last 12 months. The online survey of 321 gout patients was conducted by Harris Interactive(R) on behalf of Savient Pharmaceuticals, Inc. (Nasdaq: SVNT), whose drug Puricase(R) (PEG-uricase), is currently in Phase 3 development in symptomatic gout patients who have failed previous therapies. The survey results were released today just prior to the 2006 American College of Rheumatology Annual Scientific Meeting in Washington, D.C.

The majority of surveyed gout patients reported that a gout flare has a major or extreme impact on walking (75 percent), putting on shoes (71 percent), and participating in recreational sports and activities (70 percent). About one in five (21 percent) employed gout patients say that they have missed work in the last year due to a gout flare, with 23 percent of those respondents saying they missed seven work days or more.(1) While more than half (57 percent) of gout sufferers see a doctor for treatment, only 13 percent reported seeing a rheumatologist, the type of physician who specializes in rheumatic disorders such as gout, whereas 80 percent see a primary care physician.

"These survey findings confirm that gout is an excruciating and debilitating form of arthritis that can negatively affect daily activities, lifestyle and work productivity," said N. Lawrence Edwards, MD, Professor of Medicine, Rheumatology and Clinical Immunology, University of Florida College of Medicine, and Chairman and CEO of the newly launched Gout & Uric Acid Education Society, a non-profit, patient advocacy organization created to educate patients and healthcare providers about gout and the related consequences of hyperuricemia (http://www.gouteducation.org). "The prevalence of gout has steadily increased in recent decades due to a variety of dietary and lifestyle changes, obesity, greater use of medications that can cause high uric acid levels, and the aging population. Fortunately for patients, the first new prescription treatments for gout in 40 years are being developed."

About Gout

There are an estimated 5 million Americans with gout, including over 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. Over 2 million gout patients are treated for their hyperuricemia with the urate lowering drug, allopurinol, a xanthine oxidase inhibitor, which may take a period of years to achieve meaningful clinical outcomes, if ever.

About the Survey

The survey, conducted on behalf of Savient Pharmaceuticals, also found:

-- Although gout flares are more likely to occur in the big toe (62 percent), many also had a flare in a joint other than the big toe (52 percent).

-- The majority of gout sufferers (71 percent) report that they are currently taking prescription medication from their doctor to treat gout.

-- A vast majority of gout sufferers (95 percent) report they get gout information from their doctor.

Survey Methodology

This survey was conducted online within the United States by Harris Interactive(R) on behalf of Savient Pharmaceuticals, Inc. between October 2 and October 9, 2006 among 321 gout patients (aged 18 and over) who have experienced a gout flare, of which 98 are employed. Harris Interactive recruited the survey respondents via email through the Harris Interactive Chronic Illness Panel. Figures for age by sex, race/ethnicity, education, region and household income were weighted where necessary to bring them into line with their actual proportions in the population. Propensity score weighting was also used to adjust for respondents' propensity to be online.

With a pure probability sample of 321 one could say with a ninety-five percent probability that the overall results would have a sampling error of +/- 5.5 percentage points. Sampling error for data based on sub-samples would be higher and would vary. However, that does not take other sources of error into account. This online survey is not based on a probability sample and therefore no theoretical sampling error can be calculated.

About Puricase (PEG-uricase)

Although therapy for gout has not improved dramatically in 3 decades, this is now changing, particularly for those patients with difficult disease, with the development of Puricase (PEG-uricase), a recombinant, pegylated formulation of urate oxidase, an enzyme present in almost all mammals -- but not in humans -- that eliminates uric acid from the blood and tissues. Savient Pharmaceuticals is developing this Phase 3 compound for the control of hyperuricemia in treatment failure gout.

About Puricase (PEG-uricase) Phase 3 Clinical Studies

Savient is conducting phase 3 clinical studies with Puricase (PEG-uricase) in symptomatic gout patients who cannot benefit from conventional therapies. There is currently no available treatment option for this subset of gout patients. The Phase 3 program is designed to compare the safety and efficacy of Puricase (PEG-uricase) administered by two-hour intravenous infusion every two weeks or every four weeks versus placebo infusion, over a six-month period. Eligible patients must have hyperuricemia and symptomatic gout, and have been unresponsive to or intolerant of conventional therapy. All patients who complete the placebo-controlled trials will be invited to participate in a long-term open label extension.

Efficacy endpoints will include the level of uric acid control, an assessment of the reduction in burden of gout tophi using digital photography, reduction in the frequency of gout flares, improvement in the count of swollen and tender joints, and improvements in patient reported outcomes using the Short Form 36 (SF-36) and the Health Assessment Questionnaire-Disability Index (HAQ-DI).

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 Pharmaceuticals, Inc.

Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader markets. The Company's lead product development candidate, Puricase (PEG-uricase) for treatment failure gout, has reported positive Phase 1 and 2 clinical data; patient dosing in Phase 3 clinical studies began in May 2006. 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 markets Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.

Further information on Savient can be accessed by visiting: http://www.savientpharma.com.

Forward-Looking Statement

This news release contains forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond Savient's control.

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. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about Savient's business and the biopharmaceutical and specialty pharmaceutical industries in which Savient operates. Such risks and uncertainties include, but are not limited to, Savient's stock price and market conditions, delay or failure in developing Puricase (PEG-uricase) and other product candidates, difficulties of expanding Savient'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, Savient'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 Savient's products, economic, political and other risks associated with foreign operations, risks of maintaining protection for Savient's intellectual property, risks of an adverse determination in ongoing or future intellectual property litigation, and risks associated with stringent government regulation of the biopharmaceutical industry. Savient may not actually achieve the plans, intentions or expectations disclosed in Savient's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Savient makes. Stockholders should not place undue reliance on the forward-looking statements, which speak only as to the date of this press release. Savient's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that Savient may make. Except as required by law, Savient does not assume any obligation to update any forward-looking statements.

(1) Due to a small sample sizes, data should only be used directionally.

Author: Carol Cartwright

For further information please visit:
http://www.savientpharma.com