Savient Reaches Agreement To Sell Substantially All Assets To Crealta
- KRYSTEXXA® (pegloticase), the only product approved for refractory chronic
gout, included in the sale.
BRIDGEWATER, N.J. and GLENDALE, Wis., Dec. 11, 2013
BRIDGEWATER, N.J. and GLENDALE, Wis., Dec. 11, 2013 /PRNewswire/ --Savient
Pharmaceuticals, Inc. (NASDAQ: SVNT) ("Savient") announced today 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
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
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
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
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.
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 firstname.lastname@example.org.
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.
SVNT — G
John P. Hamill, Co- President and Chief Financial Officer
Philip K. Yachmetz, Co-President and Chief Business Officer
Kelly Sullivan / James Golden
Joele Frank, Wilkinson Brimmer Katcher
SOURCE Savient Pharmaceuticals, Inc.; Crealta Pharmaceuticals
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