Savient Pharmaceuticals Announces First Shipment to Specialty Distributors in the United States and Pricing of KRYSTEXXA(TM)
EAST BRUNSWICK, N.J., Nov. 30, 2010 /PRNewswire/ — Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that it is commencing shipment of KRYSTEXXA(TM) (pegloticase) to specialty distributors and that KRYSTEXXA will be commercially available by prescription in the United States effective December 1, 2010. A PEGylated uric acid specific enzyme, KRYSTEXXA was granted approval by the Food and Drug Administration (FDA) on September 14, 2010 for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA, targeted for this orphan population, is now the first and only therapy available to address this unmet medical need for highly symptomatic chronic gout sufferers who are refractory to conventional therapy here in the United States.
A specialty distribution network has been established that will allow healthcare providers direct access for ordering KRYSTEXXA. The wholesale acquisition cost (WAC) of KRYSTEXXA will be priced at $2,300.00 per 8 mg vial for IV administration. Savient is committed to providing patients access to our breakthrough therapy KRYSTEXXA. Through the KRYSTEXXA Connexxions(TM) program, Savient offers patients and healthcare providers coverage and reimbursement support, patient assistance and informational resources. Patient assistance support is currently available for those eligible patients in the United States who do not have insurance coverage. Additionally, Savient intends to expand the KRYSTEXXA Connexxions program to include a co-payment support program in the coming weeks. For more information, please visit www.krystexxa.com.
“The U.S. commercial availability of KRYSTEXXA is a significant milestone in our efforts to provide this novel life transforming therapy for the orphan patient population. These patients are currently suffering from a debilitating and crippling form of chronic gout and their signs and symptoms are inadequately controlled by existing medications,” stated Paul Hamelin, R.Ph., President of Savient. “We look forward to working with patients, healthcare providers and payers to identify appropriate patients to be initiated on this life transforming therapy. Once therapy is initiated, patients can be closely monitored to ensure those who exhibit sustained significant positive clinical response continue treatment with KRYSTEXXA.”
Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
Savient believes it remains on track for a full promotional launch of KRYSTEXXA in early 2011. For more information about KRYSTEXXA and the KRYSTEXXA Connexxions program for reimbursement and patient assistance, healthcare professionals and patients may call 1-800-579-7839 from 8:00 a.m. – 8:00 p.m. Eastern Time Monday through Friday, or visit www.krystexxa.com.
KRYSTEXXA(TM) (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. 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. Full prescribing information for KRYSTEXXA can be found at www.krystexxa.com.
Important Safety Information About Treatment with KRYSTEXXA
The full prescribing information for KRYSTEXXA contains a boxed warning regarding anaphylaxis and infusion reactions. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. KRYSTEXXA should only be administered in a healthcare setting and by healthcare providers prepared to manage anaphylaxis. Patients being treated with KRYSTEXXA should be pre-medicated with antihistamines and corticosteroids prior to infusion and should be closely monitored for an appropriate period of time after administration. Since the risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response, patients’ serum uric acid levels should be monitored prior to infusions and discontinuation of treatment should be considered if such levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
KRYSTEXXA is contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of hemolysis and methemoglobinemia. It is recommended that patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) be screened for G6PD deficiency before starting KRYSTEXXA.
As with most uric acid lowering therapeutics, an increase in gout flare is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued, however, gout flare prophylaxis (i.e., non-steroidal anti-inflammatory drugs [NSAID] or colchicine upon initiation of treatment) is recommended for at least the first 6 months of therapy unless medically contraindicated or not tolerated. In months 1 through 3, gout flares occurred in 74% of patients taking KRYSTEXXA every 2 weeks and in 51% of patients who received placebo. During the next three months of therapy (months 4 through 6), gout flares occurred in 41% of patients treated with KRYSTEXXA every 2 weeks and in 67% of patients who received placebo.
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. As such, caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure and such patients should be monitored closely following infusion.
As with all therapeutic proteins, there is a potential for immunogenicity with KRYSTEXXA. Due to this, patients receiving re-treatment may be at increased risk of infusion reactions and should be monitored carefully for such reactions. The impact of anti-PEG antibodies on patients’ responses to other PEG-containing therapeutics is unknown.
The most commonly reported adverse reactions (occurring in at least 5% of KRYSTEXXA-treated patients) were gout flare, infusion reaction, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
Savient will conduct a post-approval observational safety study in 500 patients treated for one year to further evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex-related adverse events, and to identify serious adverse events associated with KRYSTEXXA therapy.
Savient has worked with the FDA to create a Risk Evaluation and Mitigation Strategy (REMS) program to help physicians, healthcare providers and patients make treatment decisions for adults who suffer with chronic gout that is refractory to conventional therapy based on the KRYSTEXXA comprehensive and current benefit:risk information. The KRYSTEXXA REMS program consists of a communication plan for healthcare providers and a medication guide for patients.
Full prescribing information for KRYSTEXXA can be found at www.krystexxa.com.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA(TM) (pegloticase), which was approved by the FDA on September 14, 2010 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(R) (oxandrolone tablets, USP) CIII in the U.S.
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 our preparations to commercially launch KRYSTEXXA(TM) 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; our reliance on third parties to manufacture, market and distribute KRYSTEXXA; our ability to gain market acceptance for KRYSTEXXA among physicians, patients, healthcare payors 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.
SOURCE Savient Pharmaceuticals, Inc.