Crealta was established in August 2013 in partnership with GTCR, one of the nation's leading private equity firms.
Skadden, Arps, Slate, Meagher & Flom LLP and Cole, Schotz, Meisel, Forman & Leonard P.A. are serving as Savient's legal advisors, and Lazard is serving as its financial advisor. Kirkland & Ellis LLP is serving as legal advisor to Crealta.
KRYSTEXXA® IMPORTANT SAFETY INFORMATION
The following information is provided in both the U.S. and European prescribing information.
KRYSTEXXA® is not indicated for the treatment of asymptomatic hyperuricemia. KRYSTEXXA® is indicated for adults who have tried or cannot take oral gout medications and still have high uric acid levels and signs and symptoms of gout. Patients who have a genetic condition known as G6PD deficiency should not use 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 and infusion reactions. 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 hemolysis 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 U.S. 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 Refractory Chronic Gout (RCG) Symptoms of gout are caused by the body's response to the presence of high uric acid (urate) 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." 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 of conventional therapies.
RCG is a chronic disease that, if left untreated, can lead to chronic pain, tophi-induced joint destruction and disfigurement, and significant mobility restrictions for patients. RCG has been granted orphan drug status by the FDA due to the relatively small patient population afflicted with this debilitating condition.
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"), which developed the recombinant uricase enzyme used in the manufacture of KRYSTEXXA®, and Mountain View Pharmaceuticals, Inc. ("MVP"), which developed the PEGylation technology used in the manufacture of KRYSTEXXA®. Each of MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology. Savient also owns or co-owns U.S. and foreign patents and patent applications, which together with the patents of MVP and Duke form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA®. In the U.S., Savient also supplies Oxandrin® (oxandrolone tablets, USP) CIII and co-promotes Kineret® (anakinra) with Swedish Orphan Biovitrum AB (Sobi). For more information, please visit the Company's website at www.savient.com.
About Crealta Crealta is a specialty pharmaceutical company focused on innovative therapeutics designed to improve patient outcomes. The company was formed to acquire, develop, and market specialty pharmaceutical products with a focus on select physician specialties. For more information about Crealta, please visit www.crealtapharma.com, call 1-781-639-1910, or email email@example.com.
About GTCR Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Financial Services & Technology, Healthcare and Information Services & Technology industries. The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth. Since its inception, GTCR has invested more than $10 billion in over 200 companies. For more information, please visit www.gtcr.com.
Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that are not statements of historical fact, including statements regarding the satisfaction of conditions to the closing of the proposed asset sale, the potential of the proposed asset sale and the expectation that the Chapter 11 filings will enable us to sell our assets in an orderly manner and maximize value for our stakeholders, the necessity of bankruptcy court approvals to conduct and complete the proposed asset sale and other statements regarding our strategy, future operations, future financial positions, future performance, commercialization of KRYSTEXXA®, prospects and plans and objectives of management, should be considered forward-looking statements. We often use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "may," "predict," "will," "would," "could," "should," "target" and similar expressions to identify forward-looking statements. Actual results or events could differ materially from those indicated in forward-looking statements as a result of risks and uncertainties, including, among others, the potential adverse impact of the Chapter 11 filings on our liquidity or results of operations, changes in our ability to meet financial obligations during the Chapter 11 process or to maintain contracts that are critical to our operations, the outcome or timing of the Chapter 11 process and the proposed asset sale, the effect of the Chapter 11 filings or proposed asset sale on our relationships with third parties, regulatory authorities and employees, proceedings that may be brought by third parties in connection with the Chapter 11 process or the proposed asset sale, Bankruptcy Court approval or other conditions to the proposed asset sale, and the timing or amount of any distributions to the Company's stakeholders. For a discussion of some of the additional risks and important factors that we believe could cause actual results or events to differ from the forward-looking statements that we make, see the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. In addition, new risks and uncertainties emerge from time to time, and it is not possible for the Company to predict or assess the impact of every factor that may cause its actual results or events to differ from those contained in any forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking statements contained in this press release. Any forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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Savient Pharmaceuticals John P. Hamill, Co- President and Chief Financial Officer Philip K. Yachmetz, Co-President and Chief Business Officer firstname.lastname@example.org 908-864-7382
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