BRIDGEWATER, N.J., Nov. 12, 2012 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that new data from an open-label extension (OLE) study published in the Annals of the Rheumatic Diseases reinforced the safety and efficacy profile of KRYSTEXXA® (pegloticase) treatment for refractory chronic gout (RCG) over the long-term. OLE data aligned with outcomes seen in the KRYSTEXXA pivotal Phase III clinical trials, with no new safety signals identified. Improvements in clinical status were sustained or advanced during and up to two and a half years of additional treatment as evidenced by flare and tophus reduction first initiated in KRYSTEXXA-treated Phase III trial participants who maintained goal range urate-lowering responses. In addition to publication in the international peer-reviewed journal, two posters further demonstrating the safety and efficacy seen in the OLE study will be presented this week at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/AHRP) Annual Meeting, November 9-14, 2012.
"These data are encouraging because they confirm the long-term safety of KRYSTEXXA as well as a durable and progressive response to treatment," said Michael A. Becker, M.D., principal investigator, Professor Emeritus of Medicine, University of Chicago. "This is great news for those patients who have refractory chronic gout, or RCG, since treatment options are limited for this severe, debilitating and progressive form of gout."
The study enrolled 151 patients who completed one of the two Phase III randomized, double-blind, placebo-controlled registration trials. Patients received either 8 mg KRYSTEXXA every two weeks, or the same dose every four weeks, for the management of RCG. Consistent with Phase III trials, gout flares and injection reactions were the most frequently reported adverse events (71 percent and 44 percent of patients, respectively), and they were least common in patients with a sustained response to KRYSTEXXA and those receiving treatment every two weeks. In most patients defined as KRYSTEXXA responders in the Phase III trials, plasma and serum uric acid levels remained less than 6 mg/dL, and sustained and progressive improvements in tophus resolution and flare incidence were seen throughout the study period.
"We are pleased that the results from the open-label extension study were selected for publication by the peer-reviewed Annals of the Rheumatic Diseases and presentation at ACR/ARHP, further validating the benefits of long-term treatment with KRYSTEXXA for RCG patients," said Kenneth M. Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient. "These results mark an important milestone for KRYSTEXXA as the medical community continues to establish its place in the RCG treatment paradigm."
The KRYSTEXXA OLE publication in the ARD and the supportive full text ACR/ARHP abstracts can be found via the following links:
Annals of the Rheumatic Diseases (ARD) is an international peer review journal, and one of more than 40 specialist titles published by BMJ Group. www.ard.bmj.com. It is co-owned with the European League Against Rheumatism (EULAR).
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. KRYSTEXXAbecame 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 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 within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, and 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®, market demand and our ability to gain market acceptance for KRYSTEXXA among physicians, patients, health care payors and others in the medical community; our ability to execute on our plans for the expansion of clinical utility for KRYSTEXXA; our market expansion plans for KRYSTEXXA outside the United States, including our Marketing Authorization Application which is pending before the European Medicine Agency, our ability to service our outstanding debt obligations, our financing needs and liquidity, market acceptance of reimbursement risks with third party payors, and our view of the market size for KRYSTEXXA in the US and ex-US and our view of our penetration of this market 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. Other important factors that may affect our business are 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.
SOURCE Savient Pharmaceuticals, Inc.