BRIDGEWATER, N.J. and DUBLIN, Jan. 8, 2013 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient Pharma Ireland Ltd., today announced that the European Commission has granted a marketing authorization for KRYSTEXXA® (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
"There is currently no other treatment option in the EU for patients with severe chronic tophaceous gout who do not respond to oral xanthine oxidase inhibitors," said Dr. Thomas Bardin, MD, Professor and Head of the Rheumatology department at the Lariboisière Hospital in Paris, France. "KRYSTEXXA addresses a significant unmet medical need and represents an important development for healthcare professionals and European patients suffering from this debilitating disease."
"European approval of KRYSTEXXA demonstrates our ongoing commitment to this underserved population by offering a much needed treatment option to these patients and marks a significant milestone for the Company," said Lou Ferrari, President and Chief Executive Officer of Savient. "We continue to establish relationships with clinicians and key opinion leaders in Europe, and we anticipate product launch in the region by mid-2013."
The European Commission's approval decision was based upon safety and efficacy data from Savient's two pivotal Phase III studies, and a long-term open label extension study of KRYSTEXXA, as well as non-clinical and chemistry, manufacturing and control information.
Until the product becomes commercially available in the EU, Savient will continue to provide KRYSTEXXA to patients through the established Named Patient Programme (NPP).
ABOUT CHRONIC TOPHACEOUS GOUT Symptoms of gout are caused by the body's response to the presence of high uric acid levels which can lead to the formation of urate 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 urate crystals under the skin, called "tophi." In cases of severe debilitating chronic tophaceous gout, these symptoms have a major influence on patient health due to the frequency and severity of episodes. Although most cases of gout can be controlled with conventional urate-lowering therapy, uric acid levels may remain high and symptoms persist despite treatment efforts, even at maximum medically appropriate doses.
ABOUT KRYSTEXXA KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme for administration by intravenous infusion. The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
KRYSTEXXA was approved in the US in September 2010. KRYSTEXXA is indicated in the US for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
IMPORTANT SAFETY INFORMATION The following information is provided in both the US and European prescribing information.
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.
Warnings and Precautions:
- Anaphylaxis and infusion reactions have been reported to occur during and after administration of 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 discontinue treatment if levels rise above 6mg/dL, particularly when two consecutive levels above 6 mg/dL are observed.
- 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.
In addition, the European Summary of Product Characteristics (SmPC) includes two other special warnings and precautions for use.
- If haemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
- Patients over 100 kg body weight may have higher titers of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group.
The most commonly reported serious adverse reactions were anaphylaxis, infusion reactions and gout flares. The SmPC includes the following very common adverse reactions: gout flares, infusion reactions, nausea, dermatitis, urticaria, pruritus, skin irritation and dry skin. In the US prescribing information, the most common adverse reactions (5% or greater) reported were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.
Please see full prescribing information for KRYSTEXXA.
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 who do not respond 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 US and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns US 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 US 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 EU, market demand and reimbursement for KRYSTEXXA, our view of the market size in the US and EU, and our market expansion plans outside the US and EU 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.
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