Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) ("Savient") announced that it has reached agreement on the terms of an acquisition agreement with Crealta Pharmaceuticals LLC ("Crealta") through which Crealta would acquire substantially all of the assets of Savient, including all KRYSTEXXA® assets, for gross proceeds of approximately $120.4 million. The agreement was reached following an auction conducted pursuant to bidding procedures approved by the U.S. Bankruptcy Court for the District of Delaware (the "Court"). A hearing at which Savient and Crealta will seek the required Court approval of the sale is scheduled for Friday, December 13, 2013.
According to the terms of the acquisition agreement, Crealta will purchase Savient's pharmaceutical portfolio, which is highlighted by the chronic refractory gout drug KRYSTEXXA®. KRYSTEXXA® is a novel biologic product that was designated as an orphan drug by the FDA based on the relatively small patient population with refractory chronic gout ("RCG"). KRYSTEXXA® is a PEGylated uric acid specific enzyme, or uricase, that has been shown to dramatically reduce uric acid levels for many patients suffering from RCG.
"We are thrilled to be able to acquire KRYSTEXXA from Savient, thus ensuring the continued availability of an important therapy for patients suffering from what can be a debilitating condition," said Ed Fiorentino, Chairman and CEO of Crealta. "Crealta is committed to providing education and support to patients and their health care providers so that KRYSTEXXA can continue to be used safely and effectively. KRYSTEXXA represents the type of product that Crealta strives to deliver to patients, namely specialty products addressing significant health care conditions. We believe this is a meaningful step in Crealta's journey to becoming a leading specialty pharmaceutical company."
The transaction is subject to certain closing conditions, including approval from the Court and the termination of the waiting period under Hart-Scott-Rodino. Upon the completion of the sale, Savient's previously announced agreement with US WorldMeds, LLC and Sloan Holdings C.V. will terminate in accordance with its terms. Additional information, court filings and other documents related to this process, is available through Savient's claims agent, the Garden City Group, at www.gcginc.com/cases/svnt or 866-297-1238.
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.