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 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.
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
kaplan@kogspr.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.
SVNT — G
Contacts:
Savient Pharmaceuticals
John
P. Hamill, Co- President and Chief Financial Officer
Philip K. Yachmetz, Co-President and
Chief Business Officer
information@savient.com
908-864-7382
Kelly Sullivan / James Golden
Joele Frank, Wilkinson Brimmer
Katcher
212-355-4449
Crealta Pharmaceuticals
Cheri
Kieca
847-234-6715
SOURCE Savient Pharmaceuticals, Inc.; Crealta
Pharmaceuticals