EAST BRUNSWICK, N.J., July 2, 2012 – Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced a new publication showing that adult patients with refractory chronic gout (RCG) treated bi-weekly with KRYSTEXXA® (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The article confirms that chronic gout, especially refractory chronic gout, is associated with decline in HRQOL and physical functioning compared to patients without chronic gout. The results were published in the print edition of the July 2012 issue of The Journal of Rheumatology.
"The significant improvements we observed in KRYSTEXXA-treated patients' pain, physical function and health-related quality of life are important as the daily burden of untreated RCG can be tremendous for these patients," said Vibeke Strand, M.D., Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine. "These improvements in quality of life measures also translate into meaningful savings in terms of cumulative treatment costs for patients with RCG."
The pre-specified, pooled analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies of patients receiving treatment with KRYSTEXXA 8 mg every two weeks or every four weeks compared to placebo. At weeks one (baseline), 13, 19 and 25, investigators measured patient-reported HRQOL outcomes through four widely utilized assessment tools, namely, Medical Outcomes Study Short Form-36 (SF-36) physical component summary scores, the Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA) and pain by visual analog scale (VAS).
Results at week 25 demonstrated that mean improvements from baseline were statistically significant and exceeded minimum clinically important differences (MCID) in patients treated with KRYSTEXXA 8 mg every two weeks, the approved dose and schedule. The data demonstrate that at least 50% of patients showed improvements in HRQOL parameters except for HAQ-DI in which 45% of patients showed improvements compared to placebo. Monthly pegloticase also improved HRQOL but the effects were not as robust as the bi-weekly treatment group. There was little to no improvement seen in the placebo group.
"This study underscores the severity of functional impairment experienced by many RCG patients and there is no other treatment to date that has shown to be effective in improving HRQOL and physical function in these patients as that demonstrated by KRYSTEXXA," said Kenneth Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient. "We are pleased to have this analysis accepted for publication by The Journal of Rheumatology, which is a prestigious peer reviewed journal."
The article titled, Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials, appears in the current July 2012 issue of the Journal of Rheumatology, which can be accessed online at http://www.jrheum.org.
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.
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.
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®, status of our KRYSTEXXA marketing efforts and additional plans related thereto, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout (RCG) market size, 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, 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 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.
The Journal of Rheumatology