2014

New Analysis of Phase III Trials Shows Gout Patients with Chronic Kidney Disease at Any Stage Responded to KRYSTEXXA® Presented in Oral Session at EULAR 2012 Another Study Demonstrates Impact of Gout Pain on Quality of Life and High Unmet Need in Western Europe

EAST BRUNSWICK, N.J., June 6, 2012 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA® (pegloticase) regardless of baseline CKD stage.  CKD stage is assigned based upon level of kidney function as measured by glomerular filtration rate (GFR), with higher stages having lower GFR levels. Six additional abstracts, including a study measuring the impact of gout pain on quality of life in Western Europe, were accepted for presentation or publication at EULAR, June 6-9, 2012.

Uric acid, which is high in patients with gout, is processed and excreted primarily by the kidney.  Impairment of kidney function can alter the uric acid lowering effect of conventional gout treatments and decrease the threshold for a patient to experience treatment-related toxicity.  Some treatments for gout require a dose reduction to avoid toxicity, yet elevated uric acid has been associated with worsening kidney function.

"There are currently limited treatment options available for gout patients with CKD so these data are encouraging because they showed that KRYSTEXXA is effective regardless of CKD stage, or severity of disease, and treatment with KRYSTEXXA does not impact estimated GFR levels, an indicator of kidney function," said Robert A. Yood, M.D., Principal Investigator, Chief of Rheumatology at Reliant Medical Group, and Clinical Professor of Medicine at the University of Massachusetts Medical School.

This post-hoc analysis evaluated more than 200 patients with CKD stages one through four (n=34, 74, 80, 23, respectively) who were randomized to receive treatment with KRYSTEXXA 8 mg every other week, 8 mg every four weeks or placebo.  Baseline CKD stage was similar across treatment arms, and there was no significant difference in rates of response to KRYSTEXXA by CKD stage (p<0.311).  Additionally, treatment with KRYSTEXXA did not impact estimated GFR levels in patients with or without CKD.  Similar results were seen in a 24-month open-label extension study.

In another study presented as a poster at EULAR, 35 percent of patients diagnosed with gout in Western Europe reported experiencing pain in the last 30 days (versus 20 percent in the control group of those who did not report gout; p<0.05).  Of those patients, 23 percent reported severe daily pain (versus 13.5 percent in control group; p<0.05), which impacted quality of life as assessed by the SF-12 health outcome measurement tool.  Based on study data, it is estimated that one in five gout patients in Western Europe experiences moderate to severe daily pain, one of the symptoms of gout.

"Currently there are no approved treatments for RCG in the European Union, so there remains an unmet need in Europe for treatment options for this often debilitating form of gout.  Savient remains committed to working with European regulatory authorities to bring KRYSTEXXA to market as soon as possible," said Kenneth Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient Pharmaceuticals, Inc.

Savient is seeking approval for KRYSTEXXA in Europe and filed its Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in May 2011.  

Full text abstracts can be found via the following links:

ABOUT KRYSTEXXA®

KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme for administration by intravenous infusion for the treatment of refractory chronic gout (RCG) in adult patients. KRYSTEXXA became commercially available in the U.S. by prescription on December 1, 2010 and is the only U.S. Food and Drug Administration approved product specifically indicated for the treatment of RCG. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

For more information about KRYSTEXXA, please visit: http://www.KRYSTEXXA.com.

IMPORTANT SAFETY INFORMATION ABOUT TREATMENT WITH KRYSTEXXA®

KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia.  Patients who are at risk of having a condition known as G6PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA. 

Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do not institute oral urate-lowering therapy while the patient is on KRYSTEXXA therapy.

Possible side effects of KRYSTEXXA include:

  • Anaphylaxis which occurred in some patients treated with KRYSTEXXA. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • Infusion reactions which occurred in some patients treated with KRYSTEXXA. The risk of an infusion reaction is higher in patients who have lost therapeutic response. Because the risk of infusion reactions is higher in patients who lose therapeutic response to KRYSTEXXA, monitor serum uric acid before each infusion and consider discontinuing treatment if levels rise above 6mg/dL, particularly when two consecutive levels above 6 mg/dL are observed.
  • As with other urate-lowering therapies, an increase in gout flares was seen in some patients treated with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.  Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.

ADVERSE REACTIONS

The most commonly reported serious adverse reactions are anaphylaxis, infusion reactions and gout flares. Most common adverse reactions: gout flares (77%), infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%), nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%).

Please see the Full Prescribing Information and Medication Guide at http://www.krystexxa.com/.

ABOUT REFRACTORY CHRONIC GOUT

Gout is a painful, debilitating form of arthritis and affects approximately eight million people in the U.S. alone. A significant sub-population of gout patients, approximately 120,000, are burdened with a difficult-to-treat form of the condition, known as refractory chronic gout (RCG). Symptoms of gout are caused by the body's response to the presence of uric acid crystals in the joints and surrounding tissue, which form when uric acid levels in the blood are elevated (a condition called hyperuricemia). The longer hyperuricemia persists, the higher the risk of developing gout. Symptoms of gout may include painful flares, pain or swelling in the joints (known as "gouty arthritis") or deposits of uric acid crystals under the skin, called "tophi." In cases of RCG, these symptoms may have a major influence on patient health-related quality of life due to the frequency and severity of episodes, the recurrent pain and the disfigurement associated with this condition. Although most cases of gout can be controlled with conventional urate-lowering therapy, when uric acid levels remain high and symptoms persist despite treatment efforts, chronic gout may be defined as refractory.

ABOUT SAVIENT PHARMACEUTICALS, INC.

Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA® (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View Pharmaceuticals, Inc. ("MVP").  Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA.  Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. For more information, please visit the Company's website at www.savient.com.

FORWARD-LOOKING STATEMENTS

All statements other than statements of historical facts included in this press release are 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 our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the safety and efficacy of KRYSTEXXA®, the potential to expand the clinical utility of KRYSTEXXA, status of our KRYSTEXXA marketing efforts in the US and additional plans related thereto both in the US and ex-US, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout (RCG) market size in the US and ex-US, and our market expansion plans including our MAA filing before the EMA are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, developments that may arise in the litigation with Tang Capital; our ability to commercialize KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have anticipated; our ability to retain the personnel; our reliance on third parties to manufacture KRYSTEXXA; competition from existing therapies and therapies that are currently under development, including therapies that are significantly less expensive than KRYSTEXXA; our ability to gain market acceptance for KRYSTEXXA among physicians, patients, health care payers and others in the medical community; whether we are able to obtain financing, if needed; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak only as of the date of publication of this press release. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.

SVNT - G

Contacts:


Investor Relations 

Media Relations

Mary Coleman     

Lindsay Rocco

Savient Pharmaceuticals, Inc.  

Rx Mosaic Health      

information@savient.com  

lrocco@rxmosaic.com

(732) 418-9300 

(862) 596-1304

 

SOURCE Savient Pharmaceuticals, Inc.



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