Crealta Pharmaceuticals LLC Announces Completion of the Acquisition of
Substantially All of the Assets of Savient Pharmaceuticals, Inc.
Acquisition is highlighted by KRYSTEXXA® (pegloticase), the only product
approved for the treatment of refractory chronic gout
GLENDALE, Wis., Jan. 10, 2014
GLENDALE, Wis., Jan. 10, 2014 /PRNewswire/ --Crealta Pharmaceuticals LLC
("Crealta"), a new specialty pharmaceutical company, announced today the
completion of the acquisition of substantially all of the assets of Savient
Pharmaceuticals, Inc. ("Savient"). Crealta previously announced the winning of
an auction for these assets, the signing of a definitive acquisition agreement
with Savient, and the subsequent approval of the transaction by the U.S.
Bankruptcy Court for the District of Delaware.
The key asset acquired by Crealta is KRYSTEXXA (pegloticase), a novel biologic
product that was approved by the FDA in 2010. KRYSTEXXA is a PEGylated uric
acid specific enzyme, or uricase, that has been shown to statistically
significantly reduce uric acid levels for many patients with refractory
"We are tremendously excited to have completed the transaction, and more
importantly, to ensure the continued availability of this critical product,"
commented Ed Fiorentino, Chairman and CEO of Crealta. "Crealta is committed to
providing outstanding support and service to healthcare professionals and the
patients that they serve with refractory chronic gout."
Crealta was established in August 2013 in partnership with GTCR, one of the
nation's leading private equity firms.
KRYSTEXXA IMPORTANT SAFETY INFORMATION
The following information is provided in both the U.S. and European
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
Warnings and Precautions:
oAnaphylaxis 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
oInfusion 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
oAn 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.
oIf hemolysis and/or methemoglobinemia occur in patients receiving
KRYSTEXXA, treatment should be immediately and permanently discontinued
and appropriate measures initiated.
oPatients 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
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
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
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.
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.
SOURCE Crealta Pharmaceuticals LLC
Contact: Edna Kaplan, KOGS Communication, 781-639-1910/office,
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